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A Randomised Trial to Optimise Gestational Weight Gain and Improve Maternal and Infant Health Outcomes through Antenatal Dietary, Lifestyle and Exercise Advice: The OPTIMISE Randomised Trial

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There are well-recognised associations between excessive gestational weight gain (GWG) and adverse pregnancy outcomes, including an increased risk of pre-eclampsia, gestational diabetes and caesarean birth. The aim of the OPTIMISE randomised trial was to evaluate the effect of dietary and exercise advice among pregnant women of normal body mass index (BMI), on pregnancy and birth outcomes. The trial was conducted in Adelaide, South Australia. Pregnant women with a body mass index in the healthy weight range (18.5–24.9 kg/m2) were enrolled in a randomised controlled trial of a dietary and lifestyle intervention versus standard antenatal care. The dietitian-led dietary and lifestyle intervention over the course of pregnancy was based on the Australian Guide to Healthy Eating. Baseline characteristics of women in the two treatment groups were similar. There was no statistically significant difference in the proportion of infants with birth weight above 4.0 kg between the Lifestyle Advice and Standard Care groups (24/316 (7.59%) Lifestyle Advice versus 26/313 (8.31%) Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to 1.55; p = 0.732). Despite improvements in maternal diet quality, no significant differences between the treatment groups were observed for total GWG, or other pregnancy and birth outcomes.
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Article
A Randomised Trial to Optimise Gestational Weight
Gain and Improve Maternal and Infant Health
Outcomes through Antenatal Dietary, Lifestyle and
Exercise Advice: The OPTIMISE Randomised Trial
Jodie M. Dodd 1, 2, * , Andrea R. Deussen 1and Jennie Louise 1
1Discipline of Obstetrics & Gynaecology, and Robinson Research Institute, The University of Adelaide,
Adelaide, SA 5006, Australia; andrea.deussen@adelaide.edu.au (A.R.D.); jennie.louise@adelaide.edu.au (J.L.)
2Department of Perinatal Medicine Women’s and Children’s Hospital, North Adelaide,
Adelaide, SA 5006, Australia
*Correspondence: jodie.dodd@adelaide.edu.au
Received: 6 November 2019; Accepted: 26 November 2019; Published: 2 December 2019


Abstract:
There are well-recognised associations between excessive gestational weight gain (GWG)
and adverse pregnancy outcomes, including an increased risk of pre-eclampsia, gestational diabetes
and caesarean birth. The aim of the OPTIMISE randomised trial was to evaluate the eect of dietary
and exercise advice among pregnant women of normal body mass index (BMI), on pregnancy and
birth outcomes. The trial was conducted in Adelaide, South Australia. Pregnant women with a body
mass index in the healthy weight range (18.5–24.9 kg/m
2
) were enrolled in a randomised controlled
trial of a dietary and lifestyle intervention versus standard antenatal care. The dietitian-led dietary
and lifestyle intervention over the course of pregnancy was based on the Australian Guide to Healthy
Eating. Baseline characteristics of women in the two treatment groups were similar. There was no
statistically significant dierence in the proportion of infants with birth weight above 4.0 kg between
the Lifestyle Advice and Standard Care groups (24/316 (7.59%) Lifestyle Advice versus 26/313 (8.31%)
Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to 1.55; p=0.732).
Despite improvements in maternal diet quality, no significant dierences between the treatment
groups were observed for total GWG, or other pregnancy and birth outcomes.
Keywords: dietary and lifestyle intervention; gestational weight gain; randomised controlled trial
1. Introduction
Obesity represents a significant global health burden, with the World Health Organisation
highlighting the importance of weight gain prevention in adults of healthy weight, particularly among
women of reproductive age [
1
]. In any given 5-year period, 20% of women of reproductive age
have sucient weight gain to progress them into a higher body mass index (BMI) category [
2
,
3
].
Furthermore, the rate of weight gain is highest (approximately 700 g per year) among women of
normal BMI [
4
,
5
]. Pregnancy often represents a significant turning point in a woman’s cardiovascular
and metabolic health trajectory secondary to pregnancy-related changes, including relative insulin
resistance, which promotes weight gain [6], and risk of developing obesity subsequently [7,8].
There is substantial observational literature relating to gestational weight gain (GWG), which
has been summarised by the Institute of Medicine (IoM) [
9
,
10
]. These recommendations advocate a
GWG of 11.5 to 16.0 kg for women of normal body mass index (BMI 18.5–24.9 kg/m
2
) [
9
,
10
]. However,
approximately 40% of women gain in excess of this amount [
10
]. There are well-recognised associations
between excessive GWG and adverse pregnancy outcomes for the woman, including an increased
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Nutrients 2019,11, 2911 2 of 16
risk of pre-eclampsia, gestational diabetes and caesarean birth [
11
14
]. There are also longer-term
health consequences for women, including post-partum weight retention (PPWR) and development of
obesity [
15
17
], with over 70% of women of normal BMI retaining more than 5 kg of weight 1 year
after birth [
18
,
19
]. Women with excessive GWG also have a greatly increased risk of developing both
diabetes [20,21] and cardiovascular disease in later life [2225].
Excessive GWG is a well-recognised risk factor for high infant birth weight and is independently
associated with an increased risk of child obesity in the ospring [
26
28
], thereby creating a vicious
cycle in which the intergenerational eects of obesity are perpetuated [
29
]. Specifically, the risk of early
childhood obesity increases by a factor of 1.08 (95% CI 1.03–1.14) per kilogram of maternal weight gained
above the IoM recommendations [30]. Furthermore, it has been suggested that high maternal weight
gain may induce a persisting susceptibility of an individual to an obesogenic environment [
30
,
31
].
There is also increasing evidence for an eect of excessive maternal GWG on subsequent cardiovascular
risk and hypertension in children [27,32] and adolescents [33].
Despite recognition of the associations between excessive GWG in women of normal BMI during
pregnancy and beyond, there is more limited information describing eective antenatal dietary
interventions to optimise weight gain and improve health. In a systematic review of the literature,
12 randomised
trials involving 2713 pregnant women were identified [
34
]. Of these trials, 8 specifically
recruited 1048 women of normal BMI, although only 5 reported clinical outcomes (714 women) [
34
].
Providing a combined dietary and lifestyle intervention during pregnancy was associated with a
modest 1.25 kg dierence in weight gain (5 studies, 714 women) [
34
]. However, the eect on clinical
pregnancy outcomes was less clear, being reported in only 2 trials, with 243 women [34].
The aim of the OPTIMISE randomised trial was therefore to evaluate the eect of dietary and
exercise advice among pregnant women of normal BMI, on pregnancy and birth outcomes.
2. Materials and Methods
2.1. Trial Design
We conducted a randomised controlled trial, in which women with a BMI of 18.5 to 24.9 kg/m
2
,
and a singleton pregnancy between 10 +0–20 +0 weeks were eligible to participate [
35
]. Women with
a multiple pregnancy, or with diabetes (type 1 or type 2) diagnosed prior to pregnancy were excluded.
Ethical approval was provided by the research ethics committee of the Women’s and Children’s
Hospital (Adelaide, South Australia), approval number HREC/13/WCHN/152, and the study registered
with the Australian and New Zealand Clinical Trials Registry (ACTRN 12614000583640). Recruitment
to the trial commenced in June 2014.
Women were screened for eligibility at the time of their first antenatal appointment. All women
presenting to the Women’s and Children’s Hospital had their height and weight measured, and BMI
calculated by research sta. Eligible women were provided with information about the study and
were counselled by a research assistant, prior to their provision of written consent to participate.
Randomisation: We used a computer-based randomisation service in the Discipline of Obstetrics
and Gynaecology, The University of Adelaide. The randomisation schedule used balanced variable
blocks with stratification for parity (0 versus 1 or more) and was prepared by an investigator who was
not involved with recruitment or clinical care.
Women were randomised to either the ‘Lifestyle Advice Group’ or the ‘Standard Care Group’.
Blinding of participants was not possible given the nature of the intervention, but where possible,
antenatal care-providers, outcome assessors and data analysts were blinded to treatment allocation.
Treatment Allocation: Women randomised to the Lifestyle Advice Group received an intervention
consisting of six sessions provided across the course of pregnancy. Three sessions were face-to-face,
with two provided by the dietitian shortly after trial entry and again at 28 weeks’ gestation, and
one provided by a research assistant at 36 weeks’ gestation. Women also received three telephone
calls from the research assistant at 20, 24 and 32 weeks’ gestation. The dietary advice provided was
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consistent with current Australian dietary standards [
36
], while specifically maintaining a balance of
carbohydrates, fat and protein, and encouraging women to reduce their intake of energy dense and
non-core foods high in refined carbohydrates and saturated fats. Women were advised to increase their
intake of fibre, and to consume two servings of fruit, five servings of vegetables and three servings of
dairy each day [3638].
Tailoring of the intervention was informed by stage theories of health decision making where an
individual progresses through a series of cognitive phases when undertaking behavioural change [
39
].
The initial planning session with a research dietitian provided women with written dietary and activity
information, an individual diet and physical activity plan, recipe book and example menu plans.
Women were encouraged to set achievable goals for dietary and exercise change, supported to make
these lifestyle changes and to self-monitor their progress, using a SMART goals approach. The SMART
Goal approach includes setting goals that are specific, measurable, achievable, realistic and timely.
Therefore, a SMART goal incorporates all of these criteria to increase the chances of goal achievement.
These principles were reinforced at subsequent contacts with research sta[37,38].
Women who were randomised to the Standard Care Group received their antenatal care according
to hospital guidelines, which did not include information relating to dietary intake, physical activity or
weight gain during pregnancy.
All women were asked to complete a food frequency questionnaire, physical activity questionnaire
and quality of life assessments at trial entry, 28 and 36 weeks’ gestation and six months postpartum.
Each woman’s weight was recorded at trial entry and at 36 weeks’ gestation or nearest to birth, with
gestational weight gain determined as the dierence between weight at 36 weeks and trial entry.
All women were oered a research ultrasound at 28 and 36 weeks’ gestation to assess foetal growth
(results not presented in this manuscript). After birth, information relating to birth and infant outcomes
was obtained from the case notes by the research assistant, who remained blinded to the woman’s
allocated treatment group.
Consistent with state-wide clinical practice guidelines, all women were screened for gestational
diabetes at approximately 28 weeks’ gestation [
40
]. During the course of the trial, diagnostic criteria
for gestational diabetes changed across the state from a positive 75 g oral glucose tolerance test with
fasting blood glucose >5.5 mmol/L, or 2 h
7.8 mmol/L, to fasting blood glucose
5.1 mmol/L,
1 h 10.0 mmol/L,
or 2 h
8.5 mmol/L [
40
]. Women diagnosed with gestational diabetes remained
in the study and were oered treatment with further dietary modification and metformin or insulin
added as required to maintain appropriate glycaemic control [40].
2.2. Outcome Measures
The primary trial outcome was the proportion of infants with birth weight >4 kg. A range of
secondary study outcomes were collected and listed below.
2.2.1. Secondary Infant Outcomes
Adverse outcomes for the infant: including preterm birth before 37 weeks’ gestation; perinatal
mortality (either stillbirth (intrauterine foetal death after trial entry and prior to birth), or infant death
(death of a live born infant prior to hospital discharge, and excluding lethal congenital anomalies));
infant birth weight; infant birth weight <2500 g; infant birth weight >4500 g; large for gestational age
defined as infant birth weight >90th percentile for gestational age and infant sex; small for gestational
age defined as infant birth weight <10th percentile for gestational age and infant sex; hypoglycaemia
requiring intravenous treatment; admission to neonatal intensive care unit or special care baby unit;
hyperbilirubinaemia requiring phototherapy; nerve palsy; fracture; birth trauma; shoulder dystocia;
corticosteroid use; respiratory distress syndrome (with moderate or severe respiratory disease defined as
mean airway pressure >10 cm H
2
O and/or inspired oxygen fraction (FiO
2
)>0.80 with ventilation) [
41
];
discharge home on oxygen; patent ductus arteriosus; proven systemic infection requiring treatment;
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retinopathy of prematurity; necrotising enterocolitis; neonatal encephalopathy [
42
]; seizures; length of
hospital stay; and infant not exclusively breast fed at hospital discharge.
2.2.2. Maternal Antepartum, Labour and Birth Outcomes
Adverse outcomes for the woman: including maternal hypertension and pre-eclampsia
(in accordance
with recognised Australasian Society for the Study of Hypertension in Pregnancy
criteria) [
43
]; maternal gestational diabetes; need for and length of antenatal hospital stay; antepartum
haemorrhage requiring hospitalisation; preterm prelabour ruptured membranes; chorioamnionitis;
need and reason for induction of labour; any antibiotic use during labour; caesarean section; postpartum
haemorrhage (blood loss >600 mL); perineal trauma; wound infection; endometritis; length of postnatal
hospital stay; thromboembolic disease; maternal death.
2.2.3. Maternal Weight Change
Maternal weight changes: including total gestational weight gain; average weekly gestational
gain; gestational weight gain below, within and above IoM recommendations [
10
]; and anthropometric
assessment (skin-fold thickness measurement (SFTM), body circumferences and bio-impedance to
assess adiposity).
2.2.4. Maternal Diet and Physical Activity
Maternal changes in diet and physical activity as measured by questionnaires completed by
the woman at trial entry, 28 and 36 weeks’ gestation (Harvard Semi-quantitative Food Frequency
Questionnaire [
44
,
45
], and the Short Questionnaire to Assess Health-enhancing physical activity
(SQUASH) [46]).
2.2.5. Maternal Quality of Life
Maternal quality of life and emotional wellbeing as measured by questionnaires completed by the
woman at trial entry, 28 weeks and 36 weeks’ gestation relating to quality of life (as measured using
the SF12 Health Survey Questionnaire) [
47
]; preferences for treatment, satisfaction with care; anxiety
(as measured by the Short Form Spielberger State Trait Inventory [
48
]) and depression (as measured by
the Edinburgh Postnatal Depression Scale [49]).
2.3. Sample Size Estimate
The primary clinical endpoint was the incidence of infants born with birth weight >4 kg, with an
estimated incidence in women eligible for this trial of 8.72% [
50
]. To detect a dierence from 8.72% to
3.89% (alpha 0.05; power 70%), we required 624 women.
2.4. Analysis and Reporting of Results
All analyses followed a pre-specified statistical analysis plan, as shown in Supplementary File
1. Baseline characteristics of all randomised women were examined descriptively as an indication of
comparable treatment groups, and included maternal age, parity, race, height, weight, smoking status,
past obstetric history and a diagnosis of previous gestational diabetes. Primary and secondary outcomes
were analysed on an “intention to treat” basis, according to the treatment allocated
(Lifestyle Advice
or Standard Care) at the time of randomisation. Continuous outcomes were analysed using linear
regression, and binary outcomes were analysed using log binomial regression. Outcomes measured
at multiple time points included a time-by-treatment interaction term, with generalised estimating
equations used to account for correlation between repeated measures.
As specified in the Statistical Analysis Plan, the primary analyses were adjusted analyses based
on imputed data. Unadjusted analyses, and analyses on unimputed data (not presented), were also
performed as secondary sensitivity analyses. Adjusted models included the stratification variable
Nutrients 2019,11, 2911 5 of 16
(parity) as well as BMI (continuous variable), smoking, socio-economic status (as indicated by the
Australian Bureau of Statistics’ 2011 Socio-economic Index for Areas—Index of Relative Socio-economic
Disadvantage (SEIFA IRSD) quintile) and maternal age at trial entry as covariates.
There was one missing value for the primary outcome and other infant birth weight outcomes;
many other outcomes (including infant anthropometry, infant and maternal delivery data) had less
than 1% missing data, while infant SFTM and other maternal antenatal measures had between 20–40%
missing data. Multiple imputation by the fully conditional specification (chained equations) method
was used to create 100 complete datasets for analysis [
51
]. The imputation model included all outcomes,
all stratification variables, maternal baseline height, weight and gestational age, and maternal weight
at 36 weeks’ gestation. Estimates were derived in the standard manner by combining the estimates
from each imputation using Rubin’s rules [
51
]. As there was only one missing value for the primary
outcome, no missing not at random (MNAR) sensitivity analyses were performed. Analyses were
performed using Stata version 15 (StataCorp, 77845 Texas, USA).
Data cannot be made publicly available because of ethics and Institutional Review Board
restrictions. However, researchers can apply for data access to the corresponding author.
3. Results
3.1. Participant Characteristics
Between June 2014 and April 2017, 2602 eligible women were approached to participate, with 645
randomised, 323 (50.1%) to Lifestyle Advice and 322 (49.9%) to Standard Care, as shown in Figure 1.
Four women were randomised in error prior to the start of the trial (all four from the Lifestyle Advice
Group) and were not included in analyses, leaving a total of 641 women (319 Lifestyle Advice Group
and 322 Standard Care). A further four women (two in each group) terminated pregnancies for
foetal anomalies; four women suered a stillbirth (all in the Standard Care Group); and two liveborn
infants died after birth (both in the Lifestyle Advice Group). Two stillbirths occurred in the setting of
chorioamnionitis prior to 24 weeks’ gestation; one occurred at 40 weeks secondary to Escherichia coli
sepsis; and one unexplained stillbirth occurred at 39 weeks. One liveborn infant died secondary to
extreme prematurity following spontaneous birth at 23 weeks, and the second infant, born at 36 weeks,
died at a few hours of age from pulmonary hypoplasia secondary to multicystic dysplastic kidney
disease. Overall, 633 women and 629 liveborn infants were included in the analyses, with adequate
data available for 628 (99.8%) for the primary outcome of birth weight above 4.0 kg. There were no
maternal deaths.
The baseline characteristics of women in the two treatment groups were similar at trial entry, as
shown in Table 1. The median BMI of the cohort was 22.20 kg/m
2
(inter-quartile range (IQR) 20.87
to 23.60 kg/m
2
). The mean maternal age of participants was 31.5 years, with 59% of women in their
first ongoing pregnancy. The median gestational age at trial entry was approximately 16.3 weeks
(IQR 14.57 to 18.14 weeks), 4.4% of women were smokers, and 30.5% of women were from the highest
two quintiles of social disadvantage.
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Figure 1. Flow of participants in the trial. Notes:
1
This number excludes four women who were
randomised in error prior to trial registration.
2
Termination of pregnancy (TOP)
3
Three hundred and
twelve infants with non-missing data included in raw data analysis, one infant with missing data had
outcomes imputed and was therefore included in the imputed analysis.
4
Stillbirths excluded from
infant outcomes analysis but included for analysis of maternal antenatal outcomes only.
The baseline characteristics of women in the two treatment groups were similar at trial entry, as
shown in Table 1. The median BMI of the cohort was 22.20 kg/m
2
(inter-quartile range (IQR) 20.87 to
23.60 kg/m
2
). The mean maternal age of participants was 31.5 years, with 59% of women in their first
ongoing pregnancy. The median gestational age at trial entry was approximately 16.3 weeks (IQR
14.57 to 18.14 weeks), 4.4% of women were smokers, and 30.5% of women were from the highest two
quintiles of social disadvantage.
Eligible Women Approached
n = 2602 1
Declined n = 1961
No reason / not interested: n = 758
Too busy/ too much time involved n = 712
No to research/focus on pregnancy n = 267
Health/personal/family issues n = 65
Don’t want/need diet/lifestyle advice n = 51
In a study, don’t want to do another n = 34
Partner doesn’t approve participation n = 32
Doesn’t want extra ultrasound scans n = 31
Other n = 11
Randomised n = 641 1
Lifestyle Advice Group n = 319
Withdrawn (no consent for data use): n = 1
Miscarriage or TOP2: n = 2
Stillbirth: n = 0
Standard Care Group n = 322
Withdrawn (no consent for data use): n = 3
Miscarriage or TOP2: n = 2
Stillbirth: n = 4
Live Births n = 316
Neonatal death: n = 2
Maternal death: n = 0
Live Births n = 313
Neonatal death: n = 0
Maternal death: n = 0
Data Available for Primary Outcome n =
316
Data Available for Primary Outcome n =
312
Included in analysis:
Infant outcomes: n = 316
Maternal outcomes: n = 3164
Included in analysis:
Infant outcomes: n = 3133
Maternal outcomes: n = 3174
Figure 1.
Flow of participants in the trial. Notes:
1
This number excludes four women who were
randomised in error prior to trial registration.
2
Termination of pregnancy (TOP)
3
Three hundred and
twelve infants with non-missing data included in raw data analysis, one infant with missing data had
outcomes imputed and was therefore included in the imputed analysis.
4
Stillbirths excluded from
infant outcomes analysis but included for analysis of maternal antenatal outcomes only.
Nutrients 2019,11, 2911 7 of 16
Table 1. Baseline characteristics.
Characteristic Lifestyle Advice
(n=316) **
Standard Care
(n=317) ** Overall (n=633) **
Maternal age in (years) * 31.60 (4.63) 31.45 (4.63) 31.53 (4.76)
Gestational age at entry (weeks) +16.21 (14.43, 18.14) 16.29 (14.71, 18.14) 16.29 (14.57, 18.14)
Body mass index at entry (kg/m2)+22.17 (20.81, 23.70) 22.20 (20.90, 23.46) 22.20 (20.87, 23.60)
Height at trial entry +165.18 (7.18) 164.74 (7.18) 164.96 (7.17)
Weight at trial entry +60.56 (6.92) 60.22 (6.92) 60.39 (6.88)
Public patient #312 (98.73) 315 (99.37) 627 (99.05)
Ethnicity #
Caucasian 212 (67.09) 215 (67.82) 427 (67.46)
Asian 50 (15.82) 45 (14.20) 95 (15.01)
Indian, Pakistani, Sri Lankan 22 (6.96) 29 (9.15) 51 (8.06)
Other 32 (10.13) 28 (8.83) 60 (9.47)
Nulliparous #189 (59.81) 186 (58.68) 375 (59.24)
Smoker #15 (4.75) 13 (4.10) 28 (4.42)
SEIFA IRSD 1Quintile # ˆ
Q1 (most disadvantaged) 48 (15.19) 58 (18.30) 106 (16.75)
Q2 78 (24.68) 93 (29.34) 87 (13.74)
Q3 48 (15.19) 39 (12.30) 156 (24.64)
Q4 80 (25.32) 76 (23.97) 156 (24.64)
Q5 (least disadvantaged) 62 (19.62) 51 (16.09) 113 (17.85)
*=mean and standard deviation.
+
=median and interquartile range.
#
=number and %. ˆ =socioeconomic index
of relative social disadvantage as measured by SEIFA. ** =includes all women randomised who did not withdraw
consent to use their data, and who did not suer miscarriage or termination of pregnancy prior to 20 weeks gestation.
Note that numbers reported in this table incorporate some corrections post-randomisation to parity categories used
(as stratification variable) when randomising participants. Eighteen participants were categorised as having parity 0
at randomisation when they in fact had parity 1+, and five participants were categorised as having parity 1+at
randomisation when they in fact had parity 0.
1
SEIFA IRSD: Socio-economic Index for Areas—Index of Relative
Socio-economic Disadvantage.
3.2. Pre-Specified Infant Outcomes
There was no statistically significant dierence in the proportion of infants with birth weight
above 4.0 kg between the Lifestyle Advice and Standard Care groups (24/316 (7.59%) Lifestyle Advice
versus 26/313 (8.31%) Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to
1.55; p=0.732), as shown in Table 2.
3.3. Maternal Diet Quality
When compared with women who received standard care, women who received lifestyle advice
demonstrated improvements in their reported dietary quality as measured by the healthy eating index
(HEI) at both 28 (74.35 ±7.65 Lifestyle Advice Group vs. 72.11 ±8.21 Standard Care Group; adjusted
mean dierence 2.21; 95% CI 0.98 to 3.45; p<0.001) and 36 weeks’ gestation (74.10
±
8.77 Lifestyle
Advice Group vs. 72.50
±
8.43 Standard Care Group; adjusted mean dierence 1.57; 95% CI 0.22 to
2.91; p=0.023), as shown in Table 3. There were no observed dierences in reported physical activity,
as shown in Table 3.
3.4. Pre-Specified Maternal Antepartum Outcomes
Despite improvements in maternal diet quality, there were no dierences between the treatment
groups observed for total GWG (11.32
±
3.96 kg Lifestyle Advice versus 11.70
±
3.78 kg Standard
Care; adjusted mean dierence (aMD)—0.37; 95% CI—0.97 to 0.23; p=0
·
227), as shown in Table 4.
Similarly, there were no observed dierences in the proportion of women who gained weight above
(28 (8.72%) Lifestyle Advice versus 41 (13.16%) Standard Care; aRR 0.58; 95% CI 0.32 to 1.04; p=0.066)
or below (160 (50.71%) Lifestyle Advice versus 162 (51.68%) Standard Care; aRR 0.85; 95% CI 0.60 to
1.21; p=0.366) the IOM recommendations, as shown in Table 4.
Nutrients 2019,11, 2911 8 of 16
Table 2. Pre-specified infant outcomes by treatment group.
Outcome Lifestyle Advice
(n=316) **
Standard Care
(n=313) **
Unadjusted Estimate
(95% CI)
Unadjusted
pValue
Adjusted Estimate
(95% CI) c
Adjusted
pValue
Birthweight >4 kg a24 (7.59) 26 (8.31) 0.91 (0.54, 1.56) 0.739 0.91 (0.54, 1.55) 0.732
Birthweight (g) b3291.97 (586.20) 3370.92 (511.24) 78.96 (164.95, 7.03) 0.072 78.39 (164.00, 7.22) 0.073
Birthweight z-score b0.01 (0.87) 0.04 (0.89) 0.05 (0.18, 0.09) 0.503 0.04 (0.18, 0.09) 0.532
Gestational age at delivery (weeks)
b39.12 (2.38) 39.46 (1.63) 0.33 (0.65, 0.02) 0.040 0.34 (0.66, -0.02) 0.039
Large for gestational age a22 (6.96) 25 (8.00) 0.87 (0.50, 1.51) 0.621 0.88 (0.51, 1.52) 0.641
Small for gestational age a21 (6.65) 25 (8.01) 0.83 (0.47, 1.45) 0.512 0.84 (0.48, 1.47) 0.545
Birthweight below 2.5kg a20 (6.33) 15 (4.82) 1.31 (0.69, 2.52) 0.411 1.32 (0.69, 2.54) 0.399
Birthweight >4.5 kg d0 (0.00) 2 (0.64) 0.246
Neonatal intensive/special
care nursery admission a27 (8.54) 34 (10.89) 0.78 (0.49, 1.27) 0.323 0.80 (0.50, 1.30) 0.368
Neonatal death d2 (0.63) 0 (0.00) 0.499
Hypoglycaemia a10 (3.16) 23 (7.41) 0.43 (0.21, 0.88) 0.022 0.44 (0.21, 0.91) 0.026
Hyperbilirubinaemia a23 (7.28) 15 (4.80) 1.52 (0.81, 2.85) 0.196 1.53 (0.82, 2.87) 0.181
Shoulder dystocia a9 (2.85) 13 (4.16) 0.68 (0.30, 1.58) 0.373 0.69 (0.30, 1.59) 0.386
Nerve palsy a, d 0 (0.00) 0(0.00)
Bone fracture a, d 0 (0.00) 1 (0.32) 0.497
Birth trauma a, d 1 (0.32) 2 (0.64) 0.622
a
Number and percentage, estimates are relative risks and 95% confidence interval.
b
Mean and standard deviation, estimates are dierences in means and 95% confidence interval.
d
Due
to small numbers of events, no analysis of these outcomes was possible; the p value for comparison between groups has been calculated using a Fisher’s Exact Test. For nerve palsy, there
were no events in either group.
c
Adjusted analyses: all outcomes were adjusted for the stratification variable parity (0 vs. 1+), maternal age (continuous), maternal pre-pregnancy
body mass index (BMI) (continuous) and SEIFA IRSD Quintile. ** =includes all infants of women randomised who did not withdraw consent to use their data, and who did not suer
miscarriage or termination of pregnancy prior to 20 weeks gestation, or stillbirth.
Nutrients 2019,11, 2911 9 of 16
Table 3. Pre-specified maternal antepartum diet quality and physical activity outcomes by treatment group.
Outcome Lifestyle Advice
(n=316) **
Standard Care
(n=313) **
Unadjusted Estimate
(95% CI)
Unadjusted
pValue
Adjusted Estimate
(95% CI) f
Adjusted
pValue
Healthy Eating Index b, e <0.001 * <0.001 *
Trial Entry 72.94 (9.22) 73.56 (7.89) 0.62 (1.96, 0.72) 0.362 0.66 (1.99, 0.68) 0.334
28 Weeks 74.35 (7.65) 72.11 (8.21) 2.25 (1.01, 3.48) <0.001 2.21 (0.98, 3.45) <0.001
36 Weeks 74.10 (8.77) 72.50 (8.43) 1.60 (0.25, 2.95) 0.020 1.57 (0.22, 2.91) 0.023
Total Energy (kJ) b, e 0.017 * 0.017 *
Trial Entry 8917.75 (3182.65) 8899.67 (3796.04) 18.07 (525.98, 562.13) 0.948 20.93 (516.71, 558.57) 0.939
28 Weeks 9358.47 (3782.64) 8692.51 (2829.24) 665.95 (141.52, 1190.38) 0.013 668.81 (155.43, 1182.19) 0.011
36 Weeks 8809.72 (3233.50) 8697.78 (3132.76) 111.93 (381.78, 605.65) 0.657 114.79 (375.44, 605.03) 0.646
Glycaemic Index b, e 0.183 * 0.183 *
Trial Entry 47.23 (4.85) 47.54 (4.88) 0.31 (1.07, 0.45) 0.427 0.26 (1.01, 0.49) 0.496
28 Weeks 47.22 (3.70) 48.13 (4.46) 0.91 (1.55, 0.27) 0.005 0.86 (1.50, 0.23) 0.008
36 Weeks 47.18 (4.73) 47.79 (4.57) 0.61 (1.34, 0.12) 0.099 0.56 (1.28, 0.16) 0.124
Glycaemic Load b, e 0.113 * 0.113 *
Trial Entry 110.53 (48.61) 115.02 (67.51) 4.50 (13.76, 4.76) 0.341 4.06 (13.15, 5.02) 0.381
28 Weeks 117.43 (55.86) 114.87 (45.96) 2.56 (5.43, 10.54) 0.530 2.99 (4.89, 10.87) 0.457
36 Weeks 109.28 (46.41) 113.87 (51.31) -4.59 (-12.14, 2.95) 0.233 4.16 (11.62, 3.31) 0.275
Metabolic Equivalent Task Score b, e 0.998 * 0.998 *
Trial Entry 9809.81 (4176.78) 9744.88 (4427.83) 64.93 (607.56, 737.42) 0.850 82.27 (581.63, 746.16) 0.808
28 Weeks 9085.84 (4076.53) 9028.78 (4440.41) 57.06 (614.93, 729.06) 0.868 74.40 (588.00, 736.81) 0.826
36 Weeks 7863.59 (4848.39) 7786.89 (4609.72) 76.70 (664.65, 818.05) 0.839 94.04 (637.23, 825.32) 0.801
b
Mean and standard deviation, estimates are dierences in means and 95% confidence interval.
e
Repeated measures outcomes: models included a time by intervention interaction term,
and separate estimates of treatment eect were derived at each time point regardless of the significance of this interaction term.
f
Adjusted analyses: all outcomes were adjusted for the
stratification variable parity (0 vs. 1+), maternal age (continuous), maternal pre-pregnancy BMI (continuous) and SEIFA IRSD Quintile. * Denotes p value testing for interaction between
treatment and time, i.e., whether eect of intervention diered between time points. ** =includes all women randomised who did not withdraw consent to use their data, and who did not
suer miscarriage or termination of pregnancy prior to 20 weeks gestation, or stillbirth.
Nutrients 2019,11, 2911 10 of 16
Table 4. Pre-specified maternal antepartum outcomes by treatment group.
Outcome Lifestyle Advice
(n=316) **
Standard Care
(n=313) **
Unadjusted Estimate
(95% CI)
Unadjusted p
Value
Adjusted Estimate
(95% CI) f
Adjusted
pValue
Total Gestational Weight Gain (kg) b11.32 (3.96) 11.70 (3.78) 0.39 (0.99, 0.21) 0.205 0.37 (0.97, 0.23) 0.227
Average Weekly Gestational
Gain (kg) b0.57 (0.21) 0.60 (0.21) 0.03 (0.06, 0.01) 0.114 0.03 (0.06, 0.01) 0.132
Institute of Medicine Category: total
gestational weight gain d0.168 0.177ˆ
Below 160 (50.71) 162 (51.68) 0.85 (0.60, 1.21) 0.362 0.85 (0.60, 1.21) 0.366
Within 128 (40.57) 110 (35.16) (reference) (reference)
Above 28 (8.72) 41 (13.16) 0.57 (0.32, 1.03) 0.062 0.58 (0.32, 1.04) 0.066
Institute of Medicine Category:
weekly gestational weight gain d0.386 0.444ˆ
Below 61 (19.25) 46 (14.78) 1.40 (0.84, 2.31) 0.196 1.36 (0.82, 2.26) 0.235
Within 105 (33.12) 111 (35.47) (reference) (reference)
Above 151 (47.63) 156 (49.75) 1.03 (0.71, 1.48) 0.895 1.02 (0.70, 1.48) 0.916
Pregnancy Hypertension a5 (1.58) 4 (1.30) 1.22 (0.33, 4.51) 0.764 1.87 (0.52, 6.70) 0.338
Pre-Eclampsia/Eclampsia a6 (1.90) 9 (2.91) 0.65 (0.24, 1.81) 0.414 0.70 (0.25, 1.96) 0.502
Clinical Diagnosis of Gestational
Diabetes Mellitus a, 39 (12.43) 39 (12.46) 1.00 (0.64, 1.55) 0.995 1.02 (0.66, 1.59) 0.929
Antenatal Hospital Admission a43 (13.61) 52 (16.61) 0.82 (0.56, 1.19) 0.294 0.81 (0.56, 1.18) 0.272
Antenatal Length Stay c0.83 (4.18) 0.42 (1.49) 1.98 (1.00, 3.92) 0.049 1.99 (1.03, 3.85) 0.042
Antepartum Haemorrhage a4 (1.27) 7 (2.24) 0.57 (0.17, 1.91) 0.360 0.62 (0.18, 2.10) 0.443
Preterm Prelabour Ruptured
Membranes a5 (1.58) 4 (1.28) 1.24 (0.34, 4.57) 0.748 1.17 (0.32, 4.32) 0.814
a
Number and percentage, estimates are relative risks and 95% confidence interval regression models.
b
Mean and standard deviation, estimates are dierences in means and 95%
confidence interval.
c
Mean and standard deviation, and estimates are relative risk ratios and 95% confidence intervals.
d
Number and percentage in each category, estimates are odds
ratios and 95% confidence intervals.
f
Adjusted analyses: all outcomes were adjusted for the stratification variable parity (0 vs. 1+), maternal age (continuous), maternal pre-pregnancy
BMI (continuous) and SEIFA IRSD Quintile. ˆ Denotes p value for a global test of any dierence between categories in the multinomial logistic regression model.
Adjusted model for this
outcome required log Poisson regression with robust variance estimation due to convergence issues with the log binomial model. ** =includes all women randomised who did not
withdraw consent to use their data, and who did not suer miscarriage or termination of pregnancy prior to 20 weeks gestation, or stillbirth.
Nutrients 2019,11, 2911 11 of 16
There were no significant dierences observed between the two treatment groups with regards to
the occurrence of pregnancy-related complications, including hypertension, pre-eclampsia or eclampsia,
gestational diabetes, antepartum haemorrhage or preterm prelabour ruptured membranes, as shown in
Table 4. There were no significant dierences in the number of antenatal hospital admissions between
the two groups, however, there was a borderline statistically significant dierence in the mean number
of antenatal days in hospital (0.83 (4.18) Lifestyle Advice Group versus 0.42 (1.49) in the Standard Care
Group; aRR 1.99; 95% CI 1.03 to 3.85; p=0.042). This dierence can be explained by the extremely long
antenatal hospital admissions for three women in the Lifestyle Advice Group, as shown in Table 4.
Self-reported maternal quality of life was similar between groups, as shown in Table S1.
3.5. Pre-Specified Maternal Labour and Birth Outcomes
While there was a reduction in the risk of requiring induction of labour among women in the
Lifestyle Advice group (74 (23.42%) Lifestyle Advice versus 109 (34.96%) Standard Care; aRR 0.66;
95% CI 0.52
to 0.85; p=0
·
001), this likely reflected chance dierences in the need for induction of labour
for post-dates pregnancy (21 (28.38%) Lifestyle Advice versus 43 (39.45%) Standard Care), as shown in
Table 5. There were no significant dierences observed between the two groups with regards to risk of
caesarean birth (73 (23.17%) Lifestyle Advice versus 74 (23.79%) Standard Care; aRR 0.95; 95% CI 0.72
to 1.26; p=0.713).
Table 5. Pre-specified maternal labour and birth outcomes by treatment group.
Outcome
Lifestyle
Advice
(n=316) **
Standard
Care
(n=313) **
Unadjusted
Estimate
(95% CI)
Unadjusted
pValue
Adjusted
Estimate
(95% CI)
Adjusted
pValue
Chorioamnionitis a3 (0.95) 5 (1.60) 0.59 (0.14, 2.46) 0.470 0.56 (0.14, 2.28) 0.418
Induction of Labour a74 (23.42) 109 (34.96) 0.67 (0.52, 0.86) 0.002 0.66 (0.52, 0.85) 0.001
Antibiotics during Labour
a147 (46.52) 137 (43.75) 1.06 (0.89, 1.26) 0.486 1.04 (0.88, 1.23) 0.629
Caesarean Section a73 (23.17) 74 (23.79) 0.97 (0.73, 1.29) 0.855 0.95 (0.72, 1.26) 0.713
Emergency Caesarean
Section a41 (13.03) 45 (14.46) 0.90 (0.61, 1.33) 0.603 0.89 (0.60, 1.31) 0.560
Preterm Birth a23 (7.28) 20 (6.40) 1.14 (0.64, 2.03) 0.663 1.14 (0.64, 2.03) 0.669
Postpartum Haemorrhage
a53 (16.84) 45 (14.43) 1.17 (0.81, 1.68) 0.408 1.16 (0.80, 1.67) 0.431
Perineal Trauma a184 (58.23) 189 (60.26) 0.97 (0.85, 1.10) 0.604 0.98 (0.86, 1.11) 0.728
3rd/4th Degree Perineal
Trauma a9 (2.85) 5 (1.60) 1.78 (0.60, 5.25) 0.296 1.69 (0.57, 4.97) 0.344
Wound Infection a4 (1.27) 3 (0.99) 1.29 (0.29, 5.70) 0.740 1.45 (0.33, 6.39) 0.624
Postnatal Length Stay c1.87 (1.47) 1.88 (1.54) 0.99 (0.89, 1.11) 0.906 1.00 (0.89, 1.12) 0.951
a
Number and percentage of events, estimates are relative risks and 95% confidence interval.
c
Mean and standard
deviation, estimates are relative risk ratios and 95% confidence intervals.
f
Adjusted analyses: all outcomes were
adjusted for the stratification variable parity (0 vs. 1+), maternal age (continuous), maternal pre-pregnancy BMI
(continuous) and SEIFA IRSD Quintile. ** =includes all women randomised who did not withdraw consent to use
their data, and who did not suer miscarriage or termination of pregnancy prior to 20 weeks gestation, or stillbirth.
The mean gestational age at birth was lower in the Lifestyle Advice Group (39.12
±
2.38 weeks
Lifestyle Advice versus 39.46
±
1.63 weeks Standard Care; aMD—0.34; 95% CI—0.66 to
0.02;
p=0·039
), as shown in Table 2. While this dierence is statistically significant, the dierence is
considered clinically small, and reflective of the dierences in induction of labour for post-dates
pregnancy. The non-statistically significant dierence observed in mean infant birth weight (3291.97
±
586.20 g Lifestyle Advice versus 3370.92
±
511.24 g Standard Care; aMD—78.39; 95% CI—164.00 to
7.22; p=0.073) is also reflective of the observed dierence in mean gestational age at birth; the mean
dierence in birthweight z-score was not near statistical significance (aMD—0.04; 95% CI—0.18, 0.09,
p=0.532). There were no statistically significant dierences between the two groups with regards
to other infant outcomes, as shown in Table 2, or newborn anthropometric measures, as shown in
Table S2.
Nutrients 2019,11, 2911 12 of 16
3.6. Eect Modification by Maternal Pre-Pregnancy BMI
Pre-specified secondary analyses identified some evidence of eect modification by maternal
pre-pregnancy BMI, suggesting that the intervention may have been more eective in women with
higher maternal BMI in reducing infant birth weight and head, abdominal and chest circumferences, as
shown in Table S3. There was also some weak evidence suggesting a dierential eect of the intervention
by parity on infant birth weight, chest and arm circumference and thigh skinfold measurement, with
lifestyle advice being more eective in reducing these measures among women in their second and
subsequent pregnancy.
4. Discussion
Our findings indicate that providing lifestyle advice during pregnancy to women with BMI
within the normal range was associated with improvements in maternal diet quality over the course
of pregnancy. However, despite improvements in maternal diet, lifestyle advice was not associated
with any dierences in total gestational weight gain or risk of weight gain below or above the IOM
recommendations. There were no significant dierences in clinical outcomes for either women or their
infants, including risk of infant birth weight above 4 kg.
There were a number of strengths to our randomised trial. To our knowledge, it was the largest
of its kind recruiting women with healthy BMI during pregnancy, with comprehensive reporting of
relevant maternal and infant clinical outcomes, high rates of participant follow-up and broad inclusion
criteria. Our methodology was robust, with all participating women prospectively having their height,
weight and BMI measured, use of a central randomisation service and outcome assessors who were
blinded to the woman’s allocated treatment group. Furthermore, both the content and intensity of the
intervention reflect one that could be realistically achieved within current public antenatal care services.
Participants in our trial were predominantly white Caucasian, with less than half of women from
areas of high social disadvantage. Furthermore, 75% of eligible women declined participation due
to time constraints, lack of interest or lack of perceived need. These factors may limit our external
validity and generalisability of our findings to other patient populations.
Our systematic review evaluating dietary and lifestyle interventions in pregnant women with
healthy BMI, providing a combined intervention was associated with a modest 1.25 kg dierence in
weight gain (5 studies, 714 women) [
34
]. Overall, the methodological quality of the studies included
were of medium to high quality, and low to medium risk of bias [
34
]. The intensity and nature
of the intervention overall was poorly described, with nine interventions consisting of face-to-face
sessions with a trained professional [
52
60
]. The intensity ranged from three dietetic sessions over
pregnancy [
58
,
59
], up to one at each antenatal visit [
61
]. Three studies [
52
,
54
,
58
] provided an additional
session post-partum.
The findings of our current study are in contrast to this review [
34
], finding no clinically or
statistically significant dierence in total gestational weight gain, or risk of weight gain below or above
the IOM recommendations. However, provision of dietary and lifestyle advice during pregnancy
was associated with improvements in maternal self-reported diet quality as measured by the HEI.
These findings are consistent with those we have reported previously from both the LIMIT [
37
,
38
] and
GROW [
61
] randomised trials, highlighting the reproducibility of the intervention among pregnant
women across the BMI spectrum in eecting dietary change.
Overall, however, our findings are consistent with the broader literature describing antenatal
dietary and lifestyle interventions in pregnant women across all BMI categories [
62
]. In a comprehensive
individual participant data meta-analysis utilising data from 36 randomised trials, and more than
12,500 pregnant women, a modest eect on GWG was identified following dietary and physical activity
advice (mean dierence
0.7 kg), although there was very little eect on clinical pregnancy and
neonatal outcomes [
62
]. When considered in their totality, the available literature challenges the current
underlying rationale of providing an antenatal dietary and lifestyle intervention with the intention
of limiting weight gain as a means to improving pregnancy outcomes. GWG reflects a combination
Nutrients 2019,11, 2911 13 of 16
of maternal fat deposition, pregnancy related plasma volume expansion, breast and uterine tissue
hypertrophy, extracellular fluid, placental mass, foetal mass and amniotic fluid volume [
63
], and while
it has been considered a surrogate for adiposity gain in pregnancy, the evidence to date suggests that it
may not be readily modified simply through changes in maternal dietary intake and physical activity.
5. Conclusions
Our findings indicate that while providing lifestyle advice during pregnancy to women with BMI
within the normal range was associated with improvements in maternal diet quality, there were no
clinically or statistically significant dierences in total gestational weight gain or in clinical outcomes
for either women or their infants. Providing such an intervention in pregnancy is not advocated.
Supplementary Materials:
The following are available online at http://www.mdpi.com/2072-6643/11/12/2911/s1,
Table S1: Maternal Quality of Life, Table S2: Infant anthropometry, and Table S3: Pre-specified analysis of eect
modification by maternal pre-pregnancy BMI.
Author Contributions:
J.M.D. was responsible for conceptualisation, funding acquisition, methodology, project
administration, supervision of the trial, data curation, data interpretation, original draft preparation, writing and
review and editing. A.R.D. was responsible for trial management and administration, data curation, writing, review
and editing. J.L. was responsible for trial administration, data curation, formal data analysis and interpretation,
writing, review and editing.
Funding:
This project was funded by intramural funding from The University of Adelaide. The trial has received
competitive funding (Lloyd Cox Strategic Research Excellence Award), and ethical approval from the Women’s
and Children’s Hospital research and ethics committee. J.M.D. is supported through a NHMRC Practitioner
Fellowship (ID 1078980).
Acknowledgments:
We are indebted to the 641 women who participated in this randomised trial. The following
persons and institutions (except where indicated, in Adelaide, South Australia) participated in the OPTIMISE
Trial: Co-ordinating Team—J.M.D., A.D., J.L., A.N., L.G., A.J., C.S., F.S., Z.S., L.W., E.L., C.C., S.H., M.K. Statistical
Analyses—J.L. Adverse Events Committee—J.S., V.B., N.M. Writing Group—J.M.D., A.D., J.L. Women’s and
Children’s Hospital (South Australia): J.M.D., A.D., H.P., Midwifery Staof the Antenatal Clinic.
Conflicts of Interest:
The authors declare no conflict of interest. The funders had no role in the design of the
study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to
publish the results.
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2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access
article distributed under the terms and conditions of the Creative Commons Attribution
(CC BY) license (http://creativecommons.org/licenses/by/4.0/).
... Rodríguez-Blanque et al. [38] reported that pregnant women performed a moderate PA consisting of a warm-up; aerobic exercise, strengthening, and stretching with relaxation to limit the negative effects on the body and to optimise well-being, mood and sleep patterns. Finally, positive results were also seen by combing individual diet and PA [39]. Moreover, PA intervention entailed positive results in maternal diet quality. ...
... We facilitate the learning processes of healthcare professionals by elaborating on exercise modalities, and commencing a discussion over the components of physical fitness. Acknowledging physical-fitness components could enhance adherence of pregnant women to PA (see e.g., [39]), and empower healthcare professionals who promote PA. ...
Article
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Background Physical activity is essential to maternal and infant health. Healthcare professionals should inform pregnant women about benefits of physical activity to prevent possible health issues. Those recommendations should elaborate on relevant contemporary evidence. The aim of this study was to review evidence-based recommendations for physical activity during pregnancy. Methods A systematic search, analysis and synthesis of conducted randomised controlled trials (RCTs) was conducted from October 2021 to June 2022 in following databases: PubMed, CINAHL, ScienceDirect and Web of Science. Literature was searched using inclusion and exclusion criteria and following PRISMA recommendations. Results Benefits for pregnant-women health and well-being were reported while performing aerobic exercise, lumbar stabilization and stretching exercise, water exercise, nerve and tendon-slip exercise, resistance training and strength training. For all exercise modalities it is recommended to perform moderate intensity activities during the whole time of pregnancy. Conclusions This systematic literature review supplements current knowledge on physical activity of pregnant women. Exercise interventions are listed and suggested in an integrative model with physical-fitness components to contextualize and promote physical activity among pregnant women.
... That the BHIP intervention did not impact maternal pregnancy outcomes is in line with previous meta analyses of RCTs that found a treatment effect on GWG but not for GDM, preeclampsia, or pregnancy-induced hypertension [31] and is also consistent with prenatal lifestyle intervention studies in the United States [32] and Australia [33] and the recent IPD-meta-analysis that showed a significant reduction in Cesarean section with the intervention but not for GDM, hypertensive disorders, or preterm delivery [34]. The low rates of GDM and pre-eclampsia may reflect the general good health of our study groups. ...
... The low rates of GDM and pre-eclampsia may reflect the general good health of our study groups. The infant birth outcomes in the BHIP study were also consistent with the majority of previous meta-analysis reviews of diet and exercise interventions wherein no significant differences were reported in infant birthweight, macrosomia, or prevalence estimates of SGA and LGA infants [29,32,33,35], as well as a UK study in obese pregnant women in the United Kingdom (n = 1555) [36] and in women of all BMI categories in Brazil (n = 639) [37]. ...
Article
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A randomized two-arm prospective superiority trial tested the efficacy of a novel structured and monitored nutrition (bi-weekly counselling for individualized energy and high dairy protein diet) and exercise program (walking goal of 10,000 steps/day) (intervention) compared to usual care (control) in pregnant women to achieve gestational weight gain (GWG) within current recommendations. Women recruited in communities in southern Ontario, Canada were randomized at 12–17 weeks gestation with stratification by site and pre-pregnancy BMI to intervention (n = 119) or control (n = 122). The primary outcome was the proportion of women who achieved GWG within the Institute of Medicine recommendations. Although the intervention compared to control group was more likely to achieve GWG within recommendations (OR = 1.51; 95% CI (0.81, 2.80)) and total GWG was lower by 1.45 kg (95% CI: (−11.9, 8.88)) neither reached statistical significance. The intervention group achieved significantly higher protein intake at 26–28 week (mean difference (MD); 15.0 g/day; 95% CI (8.1, 21.9)) and 36–38 week gestation (MD = 15.2 g/day; 95% CI (9.4, 21.1)) and higher healthy diet scores (22.5 ± 6.9 vs. 18.7 ± 8.5, p < 0.005) but step counts were similar averaging 6335 steps/day. Pregnancy and infant birth outcomes were similar between groups. While the structured and monitored nutrition with counselling improved diet quality and protein intake and may have benefited GWG, the exercise goal of 10,000 steps/day was unachievable. The results can inform future recommendations for diet and physical activity in pregnancy.
... 5 A statistically significant treatment effect on total GWG must therefore be related to BMI and cannot be expected to improve pregnancy outcome unless the likelihood of keeping GWG within recommendations increases. The randomised OPTIMISE trial has shown that diet and lifestyle advice is not superior to standard care in preventing eGWG in normal weight women, 28 and the GRoW trial concluded that metformin is not superior to placebo in preventing eGWG in overweight or obese women. 10 By contrast, we found a lower risk for eGWG in metformin-treated normal weight and overweight women with PCOS compared with placebo, although the rate of eGWG in the metformin group was similar to the GRoW trial. ...
Article
Full-text available
Objective: To explore mechanisms that modulate gestational weight gain (GWG) in women with polycystic ovary syndrome (PCOS) and healthy controls. Design and participants: Pregnant women with PCOS randomised to metformin (PCOS-M, n=36) or placebo (PCOS-P, n=37), and a prospective cohort of healthy pregnant women for comparison (HC, n=15). Setting: Eleven Norwegian, Swedish, and Icelandic hospitals. Methods: Serum levels of the appetite regulating hormones leptin, ghrelin, allopregnanlone, and soluble leptin receptor (sOB-R) were determined in the first and third trimesters. Main outcome measures: Excessive GWG (eGWG) relative to body mass index according to 2009 Institute of Medicine (IOM) guideline. Serum leptin/sOB-R ratio, or free-leptin-index (FLI), as biomarker of leptin sensitivity. Serum ghrelin and allopregnanolone levels. Results: The overall prevalence of eGWG was 44% (38/86). Women with eGWG had higher first and third trimester FLI (P<0.001), and lower third trimester allopregnanolone levels (P=0.003) versus women with non-eGWG. The prevalence of eGWG was lower in PCOS-M versus PCOS-P (28% vs 62%, OR=0.4 [95% CI 0.2-0.8], P=0.005). FLI decreased during pregnancy in PCOS-M (P=0.01), but remained unaltered in PCOS-P and HC. Ghrelin and allopregnanolone levels were comparable in PCOS-M, PCOS-P and HC throughout pregnancy. Conclusion: Excessive GWG is associated with enhanced leptin resistannce, and attenuated physiological increase in serum allopegnanolone levels during pregnancy. Metformin reduces the risk for eGWG and improves leptin sensitivity in pregnant women with PCOS.
... Similar to other interventions during pregnancy, the First 1000 Days Program showed improvement in dietary behaviors illustrating that a systems-level approach can be an effective method for promoting behavior change. Previous interventions have found improvements in overall dietary intake as measured via Healthy Eating Index and the Semi Quantitative Food Frequency Questionnaire [25][26][27], decreased consumption of processed foods [28], and increased consumption of fruits and vegetables [29]. We found a decrease in consumption of sugary-drinks that has been shown to be critical in reducing post-partum weight retention [30], but we did not see changes in fruit, vegetables, and junk food intake. ...
Article
Full-text available
Background: First 1000 Days is a systems-oriented program starting in early pregnancy lasting through the first 24 months of infancy focused on preventing obesity and related risk factors among low income, mother-infant pairs. The program was developed in partnership with stakeholders to create an infrastructure for system-wide change. It includes screening for adverse health behaviors and socio-contextual factors, patient navigation and educational materials to support behavior change and social needs, and individualized health coaching for women at highest risk of obesity and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. The purpose of this study was to examine changes from the first to third trimester for women participating in the First 1000 Days Program. Methods: We collected information through self-administered questionnaires during the first and third trimester of gestation and from electronic health records relating to obesity risk factors. Measures collected included behavior (i.e., diet, physical activity and screen time) and psychosocial (i.e., anxiety) outcomes, as well as enrollment in Women, Infant, and Children (WIC) program. We examined the extent to which participation in the program was associated with changes in behaviors and psychosocial outcomes among women during pregnancy. Results: Women completed surveys at their initial and third trimester prenatal visits (n = 264). Mean age (SD) was 30.2 (5.51) years and 75% had an annual household income of <$50,000. Mean pre-pregnancy body mass index (BMI) was 27.7 kg/m2 and 64% started pregnancy with a BMI ≥ 25 kg/m2. In multivariable adjusted models, we observed decreases in intake of sugary-drinks (- 0.95 servings/day; 95% CI: - 1.86, - 0.03) and in screen time (- 0.21 h/day; 95% CI: - 0.40, - 0.01), and an increase in physical activity (0.88 days/week; 95% CI: 0.52, 1.23) from the first to third trimester. We also observed a decrease in pregnancy-related anxiety score (- 1.06 units; 95% CI: - 1.32, - 0.79) and higher odds of enrollment in Women, Infant, and Children (WIC) program (OR: 2.58; 95% CI: 1.96, 3.41). Conclusions: Our findings suggest that a systems-oriented prenatal intervention may be associated with improvements in behaviors and psychosocial outcomes during pregnancy among low-income mothers. Trial registration: ClinicalTrials.gov ( NCT03191591 ; Retrospectively registered on June 19, 2017).
... Discussing barriers and enablers to achieving the goals in follow-up visits can reinforce the change. 88 Efficient communication that emphasises the positive outcomes of lifestyle promotion reduces psychological distress and increases the chance of adherence in pregnant women. 57 Focussing on lifestyle aspects such as diet and physical activity, and factors that might hinder those such as sleep, stress, and work-life balance, rather than weight, may prevent stigmatisation. ...
Article
Full-text available
Women with maternal obesity, an unhealthy lifestyle before and during pregnancy and excess gestational weight gain have an increased risk of adverse pregnancy and birth outcomes that can also increase the risk of long-term poor health for them and their children. Pregnant women have frequent medical appointments and are highly receptive to health advice. Healthcare professionals who interact with women during pregnancy are in a privileged position to support women to make lasting healthy lifestyle changes that can improve gestational weight gain and pregnancy outcomes and halt the intergenerational nature of obesity. Midwives and obstetrical nurses are key healthcare professionals responsible for providing antenatal care in most countries. Therefore, it is crucial for them to build and enhance their ability to promote healthy lifestyles in pregnant women. Undergraduate midwifery curricula usually lack sufficient lifestyle content to provide emerging midwives and obstetrical nurses with the knowledge, skills, and confidence to effectively assess and support healthy lifestyle behaviours in pregnant women. Consequently, registered midwives and obstetrical nurses may not recognise their role in healthy lifestyle promotion specific to healthy eating and physical activity in practice. In addition, practising midwives and obstetrical nurses do not consistently have access to healthy lifestyle promotion training in the workplace. Therefore, many midwives and obstetrical nurses may not have the confidence and/or skills to support pregnant women to improve their lifestyles. This narrative review summarises the role of midwives and obstetrical nurses in the promotion of healthy lifestyles relating to healthy eating and physical activity and optimising weight in pregnancy, the barriers that they face to deliver optimal care and an overview of what we know works when supporting midwives and obstetrical nurses in their role to support women in achieving a healthy lifestyle.
... Gestational weight gain (GWG) is one of the key modi able factors associated with birth outcomes [11,12]. Components of GWG include body composition of the mother, weight of the fetus, placenta, and amniotic uid [13]. ...
Preprint
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Background Appropriate gestational weight gain (GWG) is important for optimal pregnancy outcomes. This study prospectively evaluated the associations between GWG during the second and third trimesters of pregnancy and adverse pregnancy outcomes in an urban Tanzanian pregnancy cohort. Methods We used data from a randomized clinical trial conducted among pregnant women recruited by 27 weeks of gestation in Dar es Salaam, Tanzania (N = 1,230). Women’s gestational weight was measured at baseline and at monthly antenatal visits. Weekly GWG rate during the second and third trimesters was calculated and characterized as inadequate, adequate, or excessive, in conjunction with measured or imputed early-pregnancy BMI status according to the 2009 Institute of Medicine (IOM) GWG guidelines. We used multivariable Poisson regression with a sandwich variance estimator to calculate risk ratios (RR) for associations of GWG with low birth weight, preterm birth, small for gestational age (SGA), and large for gestational age (LGA). Degree of appropriate GWG defined using additional metrics (i.e., percentage of adequacy, z-score) and potential effect modification by maternal BMI were additionally evaluated. Results According to the IOM guidelines, 517 (42.0%), 270 (22.0%), and 443 (36.0%) women were characterized as having inadequate, adequate, and excessive GWG, respectively. Overall, compared to women with adequate GWG, women with inadequate GWG had a lower risk of LGA births (RR=0.54, 95% CI: 0.36 - 0.80) and a higher risk of SGA births (RR=1.32, 95% CI: 0.95 - 1.81). ­­Women with inadequate GWG as defined by percentage of GWG adequacy had a higher risk of LBW (OR=1.93, 95% CI: 1.03 - 3.63). In stratified analyses by early-pregnancy BMI, excessive GWG among women with normal BMI was associated with a higher risk of preterm birth (RR=1.59, 95% CI: 1.03 - 2.44). Conclusions A comparatively high percentage of excessive GWG was observed among healthy pregnant women in Tanzania. Both inadequate and excessive GWGs were associated with elevated risks of poor pregnancy outcomes. Future studies among diverse SSA populations are warranted to confirm our findings, and clinical recommendations on optimal GWG should be developed to promote healthy GWG in SSA settings. Trial registration This trial was registered as “Prenatal Iron Supplements: Safety and Efficacy in Tanzania” (NCT01119612; http://clinicaltrials.gov/show/NCT01119612).
Article
Introduction: Women with overweight and obesity, and their children, are at increased risk of adverse pregnancy, birth, and longer term health outcomes, believed to be compounded by excessive gestational weight gain (GWG). Research to date has focused on interventions to reduce excessive GWG through changes to maternal diet and/or lifestyle. Areas covered: Current clinical recommendations for GWG vary according to a woman's early pregnancy body mass index, based on assumptions that associations between GWG and adverse pregnancy outcomes are causal in nature, and modifiable. While there are small differences in GWG following pregnancy interventions, there is little evidence for clinically relevant effects on pregnancy, birth, and longer term childhood outcomes. This review considers interventional studies targeting women with overweight or obesity to reduce GWG in an effort to improve maternal and infant health, and the current evidence for interventions prior to conception. Expert opinion: GWG is not modifiable via diet and lifestyle change, and continued efforts to find the 'right' intervention for women with overweight and obesity during pregnancy are unjustified. Researchers should focus on gathering evidence for interventions prior to pregnancy to optimize maternal health and weight to improve pregnancy, birth, and longer term health outcomes associated with obesity.
Article
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Background Perinatal growth abnormalities program susceptibility to childhood obesity, which is further exaggerated by maternal overweight and obesity (MO) during pregnancy. Exercise is highly accessible, but reports about the benefits of maternal exercise on fetal growth and childhood obesity outcomes are inconsistent, reducing the incentives for pregnant women to participate in exercise to improve children’s perinatal growth.Objective This systematic review and meta-analysis aims to establish evidence-based efficacy of exercise in mothers with normal weight (MNW) and MO during pregnancy in reducing the risks of perinatal growth abnormalities and childhood obesity. In addition, the impacts of exercise volume are also assessed.Methods The PubMed, ScienceDirect, Web of Science, and Cochrane Library databases were searched from inception to February 15, 2020. We included randomized controlled trials with exercise-only intervention or exercise with other confounders in pregnant MNW (body mass index, BMI 18.5–24.9 kg/m2) and MO (BMI ≥ 25 kg/m2), which were further subgrouped in the meta-analysis. Primary outcomes included birth weight, preterm birth, small for gestational age (SGA), large for gestational age (LGA), infant and childhood weight, and childhood obesity. A linear meta-regression analysis was also used to explore the effects of exercise volume on outcomes.Results99 studies were included in the meta-analysis (n = 596,876), and individual study quality ranged from fair to good according to the Newcastle–Ottawa scale assessment. Exercise only interventions in MNW reduced preterm birth by 15% (26 studies, n = 76,132; odds ratio [OR] 0.85; 95% CI 0.72, 1.01; I2 = 83.3%), SGA by 17% (33 studies, n = 92,351; OR 0.83; 95% CI 0.71, 0.98; I2 = 74.5%) and LGA by 17% (29 studies, n = 84,310; OR 0.83; 95% CI 0.74, 0.95; I2 = 60.4%). Exercise only interventions in MO reduced preterm birth by 33% (2 studies, n = 3,050; OR 0.67; 95% CI 0.70, 0.96; I2 = 0%), SGA by 27% (8 studies, n = 3,909; OR 0.73; 95% CI 0.50, 1.05; I2 = 40.4%) and LGA by 55% (9 studies, n = 81,581; OR 0.45; 95% CI 0.18, 1.11; I2 = 98.3%). Exercise only interventions in MNW reduced childhood obesity by 53% (3 studies, n = 6,920; OR 0.47; 95% CI 0.36, 0.63; I2 = 77.0%). However, no significant effect was observed in outcomes from exercise confounders in either MNW or MO. In the meta-regression, the volume of exercise-only intervention in MNW was negatively associated with birth weight, greatly driven by volumes more than 810 metabolic equivalents (MET)-min per week. Other outcomes were not associated with exercise volume.Conclusions This systematic review and meta-analysis suggests that exercise during pregnancy in both MNW and MO safely and effectively reduce the risks of preterm birth, SGA, and LGA. Furthermore, MNW exercise also reduces the risk of childhood obesity. Overall, regardless of prepregnancy BMI, maternal exercise during pregnancy provides an excellent opportunity to mitigate the high prevalence of adverse birth outcomes and childhood obesity.
Preprint
Full-text available
Background: First 1,000 Days is a systems-oriented program starting in early pregnancy lasting through the first 24 months of infancy focused on preventing obesity and related risk factors among low income, mother-infant pairs. The program was developed in partnership with stakeholders to create an infrastructure for system-wide change. It includes screening for adverse health behaviors and socio-contextual factors, patient navigation and educational materials to support behavior change and social needs, and individualized health coaching for women at highest risk of obesity and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. Methods: We collected information through self-administered questionnaires during the first and third trimester of gestation and from electronic health records relating to obesity risk factors. Measures collected included behavior (i.e., diet, physical activity and screen time) and psychosocial outcomes, as well as enrollment in Women, Infant, and Children (WIC) program. We examined the extent to which participation in the program was associated with changes in behaviors and psychosocial outcomes among women during pregnancy. Results: Women completed surveys at their initial and third trimester prenatal visits (n=264). Mean age (SD) was 30.2 (5.51) years and 75% had an annual household income of <$50,000. Mean pre-pregnancy body mass index (BMI) was 27.7 kg/m² and 64% started pregnancy with a BMI ≥ 25 kg/m². In multivariable adjusted models, we observed decreases in intake of sugary-drinks (-0.96 servings/day; 95% CI: -1.86, -0.06) and in screen time (-0.21 hours/day; 95% CI: -0.40, -0.02), and an increase in physical activity (0.87 days/week; 95% CI: 0.56, 1.17) from the first to third trimester. We also observed a decrease in pregnancy-related anxiety score (-1.06 units; 95% CI: -1.32, -0.79) and higher odds of enrollment in Women, Infant, and Children (WIC) program (OR: 2.58; 95% CI: 1.96, 3.41). Conclusions: Our findings suggest that a systems-oriented prenatal intervention is associated with improvements in behaviors and psychosocial outcomes during pregnancy among low-income mothers. Trial registration: ClinicalTrials.gov (NCT03191591; Retrospectively registered on June 19, 2017)
Article
Importance Counseling and active behavioral interventions to limit excess gestational weight gain (GWG) during pregnancy may improve health outcomes for women and infants. The 2009 National Academy of Medicine (NAM; formerly the Institute of Medicine) recommendations for healthy GWG vary according to prepregnancy weight category. Objective To review and synthesize the evidence on benefits and harms of behavioral interventions to promote healthy weight gain during pregnancy to inform the US Preventive Services Task Force recommendation. Data Sources Ovid MEDLINE and the Cochrane Library to March 2020, with surveillance through February 2021. Study Selection Randomized clinical trials and nonrandomized controlled intervention studies focused on diet, exercise, and/or behavioral counseling interventions on GWG. Data Extraction and Synthesis Independent data abstraction and study quality rating with dual review. Main Outcomes and Measures Gestational weight–related outcomes; maternal and infant morbidity and mortality; harms. Results Sixty-eight studies (N = 25 789) were included. Sixty-seven studies evaluated interventions during pregnancy, and 1 evaluated an intervention prior to pregnancy. GWG interventions were associated with reductions in risk of gestational diabetes (43 trials, n = 19 752; relative risk [RR], 0.87 [95% CI, 0.79 to 0.95]; absolute risk difference [ARD], −1.6%) and emergency cesarean delivery (14 trials, n = 7520; RR, 0.85 [95% CI, 0.74 to 0.96]; ARD, −2.4%). There was no significant association between GWG interventions and risk of gestational hypertension, cesarean delivery, or preeclampsia. GWG interventions were associated with decreased risk of macrosomia (25 trials, n = 13 990; RR, 0.77 [95% CI, 0.65 to 0.92]; ARD, −1.9%) and large for gestational age (26 trials, n = 13 000; RR, 0.89 [95% CI, 0.80 to 0.99]; ARD, −1.3%) but were not associated with preterm birth. Intervention participants experienced reduced weight gain across all prepregnancy weight categories (55 trials, n = 20 090; pooled mean difference, −1.02 kg [95% CI, −1.30 to −0.75]) and demonstrated lower likelihood of GWG in excess of NAM recommendations (39 trials, n = 14 271; RR, 0.83 [95% CI, 0.77 to 0.89]; ARD, −7.6%). GWG interventions were associated with reduced postpartum weight retention at 12 months (10 trials, n = 3957; mean difference, −0.63 kg [95% CI, −1.44 to −0.01]). Data on harms were limited. Conclusions and Relevance Counseling and active behavioral interventions to limit GWG were associated with decreased risk of gestational diabetes, emergency cesarean delivery, macrosomia, and large for gestational age. GWG interventions were also associated with modest reductions in mean GWG and decreased likelihood of exceeding NAM recommendations for GWG.
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Introduction: Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal body mass index (BMI). Methods and analysis: We will conduct a randomised controlled trial, consenting and randomising women with a live singleton pregnancy between 10+0and 20+0weeks and BMI 18.5-24.9 kg/m2at first antenatal visit, from a tertiary maternity hospital. Women randomised to theLifestyle Advice Groupwill receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant) and three telephone calls over pregnancy, in which they will be provided with dietary and lifestyle advice and encouraged to make change using a SMART goals approach. Women randomised to theStandard Care Groupwill receive routine antenatal care. The primary outcome is infant birth weight >4 kg. Secondary outcomes will include adverse infant and maternal outcomes, maternal weight change, maternal diet and physical activity changes, maternal quality of life and emotional well-being, fetal growth and costs of healthcare. We will recruit 624 women to detect a reduction from 8.72% to 3.87% (alpha 0.05 (two-tailed); power 70%) in infants with birth weight >4 kg. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs. Ethics and dissemination: Ethical approval has been obtained from the Women's and Children's Hospital ethics committee. Findings will be disseminated widely via journal publication and conference presentation(s), and participants informed of results. Trial registration number: ACTRN12614000583640.
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Objective To synthesise the evidence on the overall and differential effects of interventions based on diet and physical activity during pregnancy, primarily on gestational weight gain and maternal and offspring composite outcomes, according to women’s body mass index, age, parity, ethnicity, and pre-existing medical condition; and secondarily on individual complications. Design Systematic review and meta-analysis of individual participant data (IPD). Data sources Major electronic databases from inception to February 2017 without language restrictions. Eligibility criteria for selecting studies Randomised trials on diet and physical activity based interventions in pregnancy. Data synthesis Statistical models accounted for clustering of participants within trials and heterogeneity across trials leading to summary mean differences or odds ratios with 95% confidence intervals for the effects overall, and in subgroups (interactions). Results IPD were obtained from 36 randomised trials (12 526 women). Less weight gain occurred in the intervention group than control group (mean difference −0.70 kg, 95% confidence interval −0.92 to −0.48 kg, I²=14.1%; 33 studies, 9320 women). Although summary effect estimates favoured the intervention, the reductions in maternal (odds ratio 0.90, 95% confidence interval 0.79 to 1.03, I²=26.7%; 24 studies, 8852 women) and offspring (0.94, 0.83 to 1.08, I²=0%; 18 studies, 7981 women) composite outcomes were not statistically significant. No evidence was found of differential intervention effects across subgroups, for either gestational weight gain or composite outcomes. There was strong evidence that interventions reduced the odds of caesarean section (0.91, 0.83 to 0.99, I²=0%; 32 studies, 11 410 women), but not for other individual complications in IPD meta-analysis. When IPD were supplemented with study level data from studies that did not provide IPD, the overall effect was similar, with stronger evidence of benefit for gestational diabetes (0.76, 0.65 to 0.89, I²=36.8%; 59 studies, 16 885 women). Conclusion Diet and physical activity based interventions during pregnancy reduce gestational weight gain and lower the odds of caesarean section. There is no evidence that effects differ across subgroups of women.
Article
Background: Maternal overweight and obesity are associated with well recognised pregnancy complications. Antenatal dietary and lifestyle interventions have a modest effect on gestational weight gain without affecting pregnancy outcomes. We aimed to assess the effects on maternal and infant outcomes of antenatal metformin given in addition to dietary and lifestyle advice among overweight and obese pregnant women. Methods: GRoW was a multicentre, randomised, double-blind, placebo-controlled trial in which pregnant women at 10-20 weeks' gestation with a BMI of 25 kg/m2 or higher were recruited from three public maternity units in Adelaide, SA, Australia. Women were randomly assigned (1:1) via a computer-generated schedule to receive either metformin (to a maximum dose of 2000 mg per day) or matching placebo. Participants, their antenatal care providers, and research staff (including outcome assessors) were masked to treatment allocation. All women received an antenatal dietary and lifestyle intervention. The primary outcome was the proportion of infants with birthweight greater than 4000 g. Secondary outcomes included measures of maternal weight gain, maternal diet and physical activity, maternal pregnancy and birth outcomes, maternal quality of life and emotional wellbeing, and infant birth outcomes. Outcomes were analysed on an intention-to-treat basis (including all randomly assigned women who did not withdraw consent to use their data, and who did not have a miscarriage or termination of pregnancy before 20 weeks' gestation, or a stillbirth). The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12612001277831. Findings: Of 524 women who were randomly assigned between May, 28 2013 and April 26, 2016, 514 were included in outcome analyses (256 in the metformin group and 258 in the placebo group). Median gestational age at trial entry was 16·29 weeks (IQR 14·43-18·00) and median BMI was 32·32 kg/m2 (28·90-37·10); 167 (32%) participants were overweight and 347 (68%) were obese. There was no significant difference in the proportion of infants with birthweight greater than 4000 g (40 [16%] with metformin vs 37 [14%] with placebo; adjusted risk ratio [aRR] 0·97, 95% CI 0·65 to 1·47; p=0·899). Women receiving metformin had lower average weekly gestational weight gain (adjusted mean difference -0·08 kg, 95% CI -0·14 to -0·02; p=0·007) and were more likely to have gestational weight gain below recommendations (aRR 1·46, 95% CI 1·10 to 1·94; p=0·008). Total gestational weight gain, pregnancy and birth outcomes, maternal diet and physical activity, and maternal quality of life and emotional wellbeing did not differ significantly between groups. Similar numbers of women in both treatment groups (76% [159/208] in the metformin group and 73% [144/196] in the placebo group) reported side-effects including nausea, diarrhoea, and vomiting. Two stillbirths (placebo group) and one neonatal death (metformin group) occurred; none of the perinatal deaths were determined to be attributable to participation in the trial. Interpretation: For pregnant women who are overweight or obese, metformin given in addition to dietary and lifestyle advice initiated at 10-20 weeks' gestation does not improve pregnancy and birth outcomes. Funding: Australian National Health and Medical Research Council.
Article
Introduction: Women who commence pregnancy with a normal BMI are at the greatest risk of excessive gestational weight gain, impacting on infant birthweight, pregnancy-related complications and postpartum weight retention. Our aim was to systematically review the effect of antenatal dietary and lifestyle interventions in pregnant women with a normal BMI on maternal and infant outcomes. Material and methods: We searched Cochrane Controlled Trials Register, PubMed, Medline and the Australian and International Clinical Trials Registry with the date of the last search in July 2015. We included all published, unpublished and ongoing randomised trials recruiting women of a normal BMI, comparing dietary and/or lifestyle interventions with standard antenatal care. Results: Twelve randomised controlled trials were identified, involving a total of 2713 pregnant women with five studies reporting clinical data for 714 women with a normal BMI. Women who received a dietary and lifestyle intervention were less likely to experience gestational weight gain (4 studies, 446 women; mean difference -1.25kg; 95%CI -2.39 to -0.11), weight gain above the Institute of Medicine guidelines (4 studies, 446 women; risk ratio 0.66; 95% CI 0.53 - 0.83) and hypertension (2 studies; 243 women; Risk Ratio 0.34; 95% CI 0.13 - 0.91). There were no statistically significant differences in the occurrence of gestational diabetes, cesarean section or birthweight greater than 4 kg. Conclusion: While providing an antenatal dietary and lifestyle intervention for pregnant women of normal BMI appears to reduce gestational weight gain, the review was limited by the relatively small available sample size. Further well-designed randomised controlled trials are required. This article is protected by copyright. All rights reserved.
Article
Objective: To assess the associations of maternal prepregnancy body mass index (BMI) and rates of early-pregnancy, mid-pregnancy and total gestational weight gain with adolescent body fat distribution and cardio-metabolic outcomes. Design: Population-based prospective cohort study. Setting: Western Australia. Population: Thousand three hundred and ninety-two mothers and their children. Methods: Maternal prepregnancy weight was assessed by questionnaire. Maternal weights at a mean of 16.5 ± 2.2 SD and 34.1 ± 1.5 SD weeks of gestation were obtained from medical records. Offspring adiposity and cardio-metabolic outcomes were assessed at a median age 17.0 years [95% confidence interval (CI) range: 16.7, 17.7]. Main outcome measures: Adolescent BMI, waist circumference (WC), waist-to-hip ratio (WHR), blood pressure, total and HDL-cholesterol, triglycerides, insulin, glucose and HOMA-IR. Results: Higher prepregnancy BMI was associated with higher adolescent BMI, WC, WHR, systolic blood pressure, insulin, glucose and HOMA-IR levels (P-values <0.05). Adjustment for adolescent current BMI attenuated the associations of prepregnancy BMI with adolescent cardio-metabolic outcomes. Higher weight gain in early-pregnancy, but not mid-pregnancy, was associated with higher adolescent BMI, WC and WHR (P-values <0.05), but not with other cardio-metabolic risk factors. Total gestational weight gain was associated with adolescent BMI and WC (P-values <0.05). Higher prepregnancy BMI and early-pregnancy weight gain were associated with increased risks of the high-metabolic risk cluster in adolescents (OR 1.57, 95% CI 1.33, 1.85 and OR 1.23, 95% CI 1.03, 1.47 per SD increase in prepregnancy BMI and early-pregnancy weight gain, respectively). Conclusions: Higher maternal prepregnancy BMI and early-pregnancy weight gain rate are associated with an adverse adolescent cardio-metabolic profile. These associations are largely mediated by adolescent BMI.
Article
In a new trial, provision of antenatal dietary and lifestyle advice to pregnant women who are obese is associated with modest improvements in maternal diet. This intervention is, however, inadequate to affect pregnancy and birth outcomes, and challenges the notion that limiting gestational weight gain can improve pregnancy outcomes.
Article
OBJECTIVE: To determine the feasibility of implementing a community-based exercise/dietary intervention program targeted at socioeconomically deprived pregnant women living in an urban core in an attempt to reduce risks of obesity and diabetes. METHODS: Fifty-two participants were enrolled and randomized into additional intervention (AI) and standard care (SC) groups. Participants in the AI group undertook group and home-based exercises during pregnancy and received computer-assisted Food Choice Map dietary interviews and counselling. Participants in the SC group received an information package on diet and activity for a healthy pregnancy. RESULTS: Forty-five participants completed the study (SC group, n=21; AI group, n=24). No adverse effects of exercise were observed during the study. Physical activity levels in the AI group were greater than those in the SC group (p<0.01). Favourable trends in the reduction of excessive weight gain, gestational diabetes mellitus, macrosomia and the requirement for weight-related procedures during birth were found in the AI group compared with the SC group. CONCLUSIONS: The results of this pilot study demonstrated the feasibility of the lifestyle intervention during pregnancy and its potential to improve pregnancy outcomes in urban communities.