Article

Effect of a Free Prepared Meal and Incentivized Weight Loss Program on Weight Loss and Weight Loss Maintenance in Obese and Overweight Women: A Randomized Controlled Trial

School of Medicine, University of California, San Diego, and Moores UCSD Cancer Center, La Jolla, California 92093, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 10/2010; 304(16):1803-10. DOI: 10.1001/jama.2010.1503
Source: PubMed

ABSTRACT

The prevalence of overweight and obesity in the United States remains high. Commercial weight loss programs may contribute to efforts to reduce the prevalence of overweight and obesity, although few studies have examined their efficacy in controlled trials.
To test whether a free prepared meal and incentivized structured weight loss program promotes greater weight loss and weight loss maintenance at 2 years compared with usual care.
A randomized controlled trial of weight loss and weight loss maintenance in 442 overweight or obese women (body mass index, 25-40) aged 18 to 69 years (mean age, 44 years) conducted at US institutions over 2 years with follow-up between November 2007 and April 2010.
The program, which involves in-person center-based or telephone-based one-to-one weight loss counseling, was available over a 2-year period. Behavioral goals were an energy-reduced, nutritionally adequate diet, facilitated by the inclusion of prepackaged food items in a planned menu during the initial weight loss phase, and increased physical activity. Participants assigned to usual care received 2 individualized weight loss counseling sessions with a dietetics professional and monthly contacts.
Weight loss and weight loss maintenance.
Weight data were available at 24 months for 407 women (92.1% of the study sample). In an intent-to-treat analysis with baseline value substitution, mean weight loss was 7.4 kg (95% confidence interval [CI], 6.1-8.7 kg) or 7.9% (95% CI, 6.5%-9.3%) of initial weight at 24 months for the center-based group, 6.2 kg (95% CI, 4.9-7.6 kg) or 6.8% (95% CI, 5.2%-8.4%) for the telephone-based group, and 2.0 kg (95% CI, 0.6-3.3 kg) or 2.1% (95% CI, 0.7%-3.5%) for the usual care control group after 24 months (P < .001 for intervention effect).
Compared with usual care, this structured weight loss program resulted in greater weight loss over 2 years.
clinicaltrials.gov Identifier: NCT00640900.

Full-text

Available from: Nancy E Sherwood, Feb 10, 2014
ORIGINAL CONTRIBUTION
Effect of a Free Prepared Meal
and Incentivized Weight Loss Program
on Weight Loss and Weight Loss Maintenance
in Obese and Overweight Women
A Randomized Controlled Trial
Cheryl L. Rock, PhD, RD
Shirley W. Flatt, MS
Nancy E. Sherwood, PhD
Njeri Karanja, PhD
Bilge Pakiz, EdD
Cynthia A. Thomson, PhD, RD
T
HE PREVALENCE OF OVER-
weight and obesity in the United
States remains high. National
survey data for 2007-2008 in-
dicate that 33.8% of adults are obese
(body mass index [BMI; calculated as
weight in kilograms divided by height
in meters squared] 30), and the preva-
lence for overweight and obesity com-
bined (BMI 25) is 68.0%.
1
Obesity is
associated with an increased risk for nu-
merous medical problems, especially hy-
pertension, diabetes, dyslipidemia, and
the metabolic syndrome.
2
Other comor-
bidities associated with overweight and
obesity include gallbladder disease, sleep
apnea, osteoarthritis, hyperuricemia, and
lower quality of life.
3-5
Excess mortality
associated with obesity is primarily at-
tributable to cardiovascular disease, dia-
betes, kidney disease, and several types
of cancer.
6,7
Given the magnitude of the prob-
lem, clinical and public health guide-
lines recommend screening and pre-
scribing treatment programs for those
who are already overweight or obese.
8,9
Although commercial weight loss pro-
grams are popular, there is a paucity of
scientific evidence on which to judge
their efficacy.
10
Only a few studies
10-12
suggest that some programs have the po-
tential to promote a degree of weight loss
that equals or exceeds office-based coun-
seling or medical interventions.
The first aim of this study was to test
in a randomized controlled trial whether
participation in a free prepared meal and
For editorial comment see p 1837.
Author Affiliations are listed at the end of this article.
Corresponding Author: Cheryl L. Rock, PhD, RD, Moores
UCSD Cancer Center, 3855 Health Sciences Dr, Office
3077, La Jolla, CA 92093 (clrock@ucsd.edu).
Context The prevalence of overweight and obesity in the United States remains high.
Commercial weight loss programs may contribute to efforts to reduce the prevalence
of overweight and obesity, although few studies have examined their efficacy in con-
trolled trials.
Objective To test whether a free prepared meal and incentivized structured weight
loss program promotes greater weight loss and weight loss maintenance at 2 years
compared with usual care.
Design, Setting, and Participants A randomized controlled trial of weight loss
and weight loss maintenance in 442 overweight or obese women (body mass index,
25-40) aged 18 to 69 years (mean age, 44 years) conducted at US institutions over 2
years with follow-up between November 2007 and April 2010.
Intervention The program, which involves in-person center-based or telephone-
based one-to-one weight loss counseling, was available over a 2-year period. Behav-
ioral goals were an energy-reduced, nutritionally adequate diet, facilitated by the in-
clusion of prepackaged food items in a planned menu during the initial weight loss
phase, and increased physical activity. Participants assigned to usual care received 2
individualized weight loss counseling sessions with a dietetics professional and monthly
contacts.
Main Outcome Measures Weight loss and weight loss maintenance.
Results Weight data were available at 24 months for 407 women (92.1% of the
study sample). In an intent-to-treat analysis with baseline value substitution, mean
weight loss was 7.4 kg (95% confidence interval [CI], 6.1-8.7 kg) or 7.9% (95% CI,
6.5%-9.3%) of initial weight at 24 months for the center-based group, 6.2 kg (95%
CI, 4.9-7.6 kg) or 6.8% (95% CI, 5.2%-8.4%) for the telephone-based group, and
2.0 kg (95% CI, 0.6-3.3 kg) or 2.1% (95% CI, 0.7%-3.5%) for the usual care control
group after 24 months (P .001 for intervention effect).
Conclusion Compared with usual care, this structured weight loss program re-
sulted in greater weight loss over 2 years.
Trial Registration clinicaltrials.gov Identifier: NCT00640900
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incentivized center-based or telephone-
based intervention promotes greater
weight loss and weight loss mainte-
nance at 2 years in overweight or obese
women compared with usual care. A sec-
ondary aim of the study was to de-
scribe the effect of participating in the
program (vs usual care) on selected bio-
chemical factors, cardiopulmonary fit-
ness, quality of life, and eating atti-
tudes and behaviors. Biochemical factors
under study include plasma lipids (fast-
ing levels of total cholesterol and tri-
glycerides, low-density lipoprotein cho-
lesterol, and high-density lipoprotein
cholesterol), C-reactive protein (CRP),
and plasma carotenoids, a biomarker of
intake of fruits and vegetables.
METHODS
Participants were enrolled at 4 study
sites (University of California, San
Diego; University of Arizona, Tucson;
University of Minnesota, Minneapo-
lis; and Center for Health Research, Kai-
ser Permanente Center Northwest,
Portland, Oregon). Participants were re-
cruited using list serves and flyers dis-
tributed by the research staff at each site.
Eligibility criteria included age 18 years
or older; BMI of 25 to 40 and a mini-
mum of 15 kg over ideal weight as de-
fined by the 1983 Metropolitan Life In-
surance tables
13
; not pregnant or
breastfeeding or planning to become
pregnant in the next 2 years; willing to
participate in any of the 3 study groups
over a 2-year period; no eating disor-
ders, food allergies, or intolerances; and
willing and able to perform a simple
step test for assessing cardiopulmo-
nary fitness. Women at BMI levels of
greater than 40 were excluded be-
cause such extreme obesity is associ-
ated with more serious comorbid con-
ditions and is more likely to require a
higher intensity and more supervised
clinical approach to weight loss and
exercise. The sample was limited to
women because men comprise the mi-
nority of enrollees in weight loss pro-
grams. Current active involvement in
another diet intervention study or or-
ganized weight loss program or hav-
ing a history or presence of a signifi-
cant psychiatric disorder or any other
condition that in the investigator’s judg-
ment would interfere with participa-
tion in the trial also disqualified women.
Information about demographic char-
acteristics, including race/ethnicity (by
prespecified categories), was collected
by self-report from participants at base-
line. The purpose was to describe the
characteristics of the sample popula-
tion.
Participants were randomly as-
signed in a 3:3:2 allocation to the center-
based intervention, the telephone-
based intervention, or the usual care
group (F
IGURE 1). Four participants
found to be ineligible postrandomiza-
tion were excluded from the analysis.
A Web-based data application was run
at each clinical site by research staff that
used a randomization sequence gener-
ated by the study statistician. Center-
based intervention participants were as-
signed to a conveniently located center
and an initial appointment to begin the
program. Participants assigned to the
telephone-based study group were con-
tacted to initiate telephone interac-
tions. All participants were provided a
small monetary compensation ($25) for
each completed clinic visit, but no re-
imbursement was provided for partici-
pation in the intervention or counsel-
ing sessions. The institutional review
boards at all of the institutions in-
volved approved the protocol prior to
study initiation. All participants pro-
vided written informed consent.
Intervention
Participants assigned to the center-
based or telephone-based study groups
received all program materials, includ-
ing free-of-charge prepackaged pre-
pared foods as needed to achieve a meal
plan. Interactions between corporate-
trained and supervised staff and the par-
ticipants consisted of brief weekly one-
to-one contacts with an in-person or
telephone counselor, with follow-up tele-
Figure 1. Flow of Participants Through Trial
446 Randomized
167 Included in primary analysis
2 Excluded postrandomization
(ineligible)
111 Included in primary analysis
2 Excluded postrandomization
(ineligible)
164 Included in primary analysis
9 Discontinued intervention
8 Pregnancies
1 Excluded postrandomization
due to active enrollment in
weight loss program at time of
randomization
1 Discontinued intervention because
withdrew consent
2 Discontinued intervention due
to pregnancies
564 Women assessed for eligibility
169 Randomized to receive
center-based intervention
168 Received intervention as
randomized
1 Did not receive intervention
(excluded postrandomization
because preferred vegan diet)
113 Randomized to receive usual care
111 Received intervention as
randomized
2 Did not receive intervention
(excluded postrandomization
due to refusal to participate)
164 Randomized to receive
telephone-based intervention
164 Received intervention as
randomized
Primary end point measured
164 At 6 mo
159 At 12 mo
151 At 24 mo
Primary end point measured
103 At 6 mo
101 At 12 mo
103 At 24 mo
Primary end point measured
162 At 6 mo
157 At 12 mo
153 At 24 mo
118 Excluded
114 Did not meet inclusion criteria
2 Refused to participate
1 Had gastric bypass surgery
1 Did not complete surveys
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phone and e-mail contacts and Web site
or message board availability. Counsel-
ors were instructed to provide the pro-
gram as designed for a regular paying cli-
ent, although they were not blinded to
the identity of study participants. Free-
of-charge counseling sessions were of-
fered to participants for the entire 2-year
period.
The diet component of the program
consisted of a nutritionally adequate,
low-fat (20%-30% of energy), reduced-
energy diet (typically 1200-2000 kcal/d)
that included prepackaged prepared food
items with increased amounts of veg-
etables and fruits to reduce the energy
density of the diet. The approach was tai-
lored so that participants could choose
regular foods when preferred. Partici-
pants were encouraged during the ini-
tial period to follow a menu plan with
prepackaged foods, which would pro-
vide 42% to 68% of energy for those who
choose not to deviate from the plan.
Regular foods, such as vegetables, fruit,
cereal or grain products, low-fat dairy
products, lean meat or the equivalent,
and unsaturated fat sources were rec-
ommended to achieve the total pre-
scribed energy intake. Over time, par-
ticipants were transitioned to a meal plan
based mainly on food not provided by
the commercial program, although par-
ticipants could choose to include 1 pre-
packaged meal per day during weight
loss maintenance. Prepared foods and
counselors were provided by Jenny Craig
Inc (Carlsbad, California).
Increased physical activity was an-
other program component; the goal was
30 minutes of physical activity on 5 or
more days per week. Program material
and counseling addressed attitudes about
weight, food, and physical activity and
included recipes and guidance for eat-
ing in restaurants, CDs and DVDs to in-
crease physical activity, and online tools
and support.
Participants assigned to the usual
care group were provided consulta-
tion with a research staff dietetics pro-
fessional, who provided publicly avail-
able print material that described dietary
and physical activity guidelines to pro-
mote weight loss and maintenance at
baseline (after randomization) and
again at 6 months. Energy intake level
to achieve a weight loss of 10% over a
6-month period was prescribed, aim-
ing for a deficit of 500 to 1000 kcal/
d.
14
Sample meal plans based on food
groups, recommendations to increase
physical activity, and written materi-
als and resources for strategies and skills
(eg, reading food labels, estimating serv-
ing sizes, eating outside the home) were
provided. This 1-hour session was fol-
lowed by monthly check-in via e-mail
or telephone, and progress and strate-
gies were discussed in a follow-up coun-
seling session at 6 months.
Assessment of Study Outcomes
Anthropometric measures (height,
weight, waist circumference) and re-
sponses to questionnaires (the Beck
Depression Inventory,
15
the Short Form
36 Quality of Life Questionnaire,
16
and
the Eating Disorder Examination
Questionnaire
17
) were collected by in-
stitution research staff (usually un-
blinded) at clinic visits at enrollment and
every 6 months over a 2-year period. The
3-minute step test was used to assess
aerobic fitness. This test measures heart
rate during the first 30 seconds of re-
covery from stepping, and although less
accurate than measuring maximal oxy-
gen uptake, the test has high reliability
and is sensitive to change.
18
Laboratory Measurements
High-sensitivity CRP was assayed using
the SPQ High Sensitive CRP Assay kit
(DiaSorin Inc, Stillwater, Minnesota), a
polystyrene-enhanced turbidimetric in
vitro immunoassay.
19,20
Leptin was mea-
sured at the Laboratory for Clinical Bio-
chemistry Research at the University of
Vermont, in Colchester, using Lumi-
nex technology and Human Serum Adi-
pokine Panel B LINCOplex Kit (Linco
Research Inc, St Charles, Missouri).
Plasma levels of total cholesterol, tri-
glycerides, and high-density lipopro-
tein cholesterol were measured using en-
zymatic methods with the Kodak
Ektachem Analyzer system (Johnson &
Johnson Clinical Diagnostics, Roches-
ter, New York). Low-density lipopro-
tein cholesterol values were calculated
using the Friedewald equation.
21
Plasma
carotenoid concentrations were mea-
sured by high-performance liquid chro-
matography.
22
Statistical Analysis
Power calculations based on pilot data
12
assumed a 1-year mean (SD) effect
size of 6.6 (10.2) kg in the interven-
tion groups vs 0.7 (5.5) kg in the con-
trol group. Fewer control (n=110) than
intervention (n=165 per group) par-
ticipants were required based on these
unequal variances. Allowing for up to
33% attenuation in weight loss be-
tween year 1 and 2, and a 25% drop-
out rate at year 2,
11
we had 83% power
to detect an intervention effect. Analy-
ses of anthropometric data were con-
ducted as intent to treat, using base-
line value substitution as the primary
approach. This approach assumes that
those who did not complete clinic vis-
its or dropped out returned to their
baseline weight (based on the usual re-
cidivism after weight loss).
23
We also
conducted intent-to-treat analysis using
multiple imputation. Furthermore, we
report mean weights for completers at
each time point, recognizing a likely
bias because dropouts may exhibit more
nonadherence and weight rebound. Sta-
tistical significance was set at a 2-sided
P value of less than .05 without adjust-
ment for multiple comparisons.
The primary outcome was weight
loss over time based on an interaction
between treatment group and time. Lin-
ear mixed models (with baseline and
usual care as the reference category)
were used to analyze weight trajecto-
ries and other primary and secondary
outcomes by group over time, includ-
ing group, time, and their interaction
as predictors. Models were used to test
for differences by group at baseline and
by time for usual care. The interaction
term modeled the intervention effect.
A subject-specific intercept represent-
ing baseline levels of the outcome was
included as a random effect in each
model. All analyses were conducted
using SAS version 9.2 (SAS Institute Inc,
Cary, North Carolina).
WEIGHT LOSS AND MAINTENANCE PROGRAM IN WOMEN
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RESULTS
The study sample consisted of 442
women aged 18 to 69 years with a mean
age of 44 years, and a race/ethnicity dis-
tribution of non-Hispanic white (n=326
or 73%), Hispanic (n=60 or 14%), and
black (n =38 or 9%) (T
ABLE 1). No dif-
ferences in baseline characteristics across
the study groups were observed. Partici-
pants were recruited between Novem-
ber 2007 and March 2008 and were fol-
lowed up for 2 years ending in April
2010. Weight data at 24 months were
available for 407 women (92.1% of the
study sample). Attrition did not differ by
study group (Figure 1 and T
ABLE 2).
Although weekly counseling ses-
sions were available for participants in
the intervention groups throughout the
2-year period, not all participants used
them. When we polled these partici-
Table 2. Anthropometric Data
a
Mean (95% Confidence Interval)
Intent-to-Treat Analysis (N = 442) Women With Measured Weight Data
Baseline 6 mo 12 mo 24 mo Baseline 6 mo 12 mo 24 mo
Center-Based Intervention
(n = 167) (n = 167) (n = 167) (n = 167) (n = 167) (n = 164) (n = 159) (n = 151)
Weight, kg 92.2
(90.7 to 93.7)
83.0
(81.4 to 84.5)
82.1
(81.3 to 84.6)
84.8
(83.0 to 86.5)
92.2
(90.6 to 93.6)
82.8
(81.3 to 84.4)
81.5
(79.8 to 83.2)
83.8
(82.0 to 85.7)
WC, kg −9.2
(−9.9 to −8.4)
−10.1
(−11.2 to −9.0)
−7.4
(−8.7 to −6.1)
−9.4
(−10.1 to −8.6)
−10.6
(−11.7 to −9.5)
−8.2
(−9.5 to −6.8)
BMI 33.8
(33.3 to 34.4)
30.5
(29.9 to 31.0)
30.2
(29.6 to 30.8)
31.2
(30.5 to 31.8)
33.8
(33.3 to 34.3)
30.4
(29.9 to 31.0)
30.0
(29.4 to 30.7)
30.8
(30.2 to 31.5)
Waist, cm 108.9
(107.6 to 110.3)
99.6
(98.2 to 101.0)
98.0
(96.5 to 99.5)
101.5
(100.0 to 103.0)
108.9
(107.6 to 110.3)
99.4
(98.0 to 100.8)
97.2
(95.7 to 98.6)
100.3
(98.7 to 101.8)
c
Telephone-Based Intervention
(n = 164) (n = 164) (n = 164) (n = 164) (n = 164) (n = 162) (n = 157) (n = 153)
Weight, kg 92.9
(91.1 to 94.7)
84.6
(82.8 to 86.4)
84.4
(82.3 to 86.5)
86.6
(84.4 to 88.9)
92.9
(91.1 to 94.7)
84.5
(82.7 to 86.3)
83.8
(81.7 to 85.9)
86.1
(83.8 to 88.4)
WC, kg −8.3
(−9.1 to −7.5)
−8.5
(−9.7 to −7.2)
−6.2
(−7.6 to −4.9)
−8.4
(−9.2 to −7.6)
−8.9
(−10.1 to −7.6)
−6.7
(−8.2 to −5.2)
BMI 33.8
(33.3 to 34.3)
30.8
(30.3 to 31.4)
30.7
(30.1 to 31.4)
31.5
(30.4 to 32.2)
33.8
(33.3 to 34.3)
30.8
(30.2 to 31.4)
30.5
(29.8 to 31.2)
31.3
(30.6 to 32.0)
Waist, cm 108.5
(106.9 to 110.0)
100.0
(97.5 to 101.4)
99.9
(98.5 to 101.6)
102.0
(100.0 to 103.9)
108.5
(106.9 to 110.0)
99.9
(98.4 to 101.4)
99.1
(97.4 to 100.8)
100.8
(98.8 to 102.8)
Usual Care
(n = 111) (n = 111) (n = 111) (n = 111) (n = 111) (n = 103) (n = 101) (n = 103)
Weight, kg 91.0
(89.0 to 92.9)
88.1
(86.0 to 90.2)
88.5
(86.3 to 90.8)
89.0
(86.7 to 91.3)
91.0
(89.0 to 92.9)
87.4
(85.3 to 89.6)
87.7
(85.4 to 90.0)
87.8
(86.3 to 91.1)
WC, kg −2.9
(−3.8 to −2.0)
−2.4
(−3.6 to −1.2)
−2.0
(−3.3 to −0.6)
−3.1
(−4.1 to −2.2)
−2.7
(−3.9 to −1.4)
−2.1
(−3.6 to −0.7)
BMI 34.0
(33.4 to 34.6)
32.9
(32.2 to 33.6)
33.2
(32.4 to 33.9)
33.4
(32.5 to 34.2)
b
34.0
(33.4 to 34.6)
32.7
(33.2 to 34.7)
32.9
(32.1 to 33.7)
33.0
(32.5 to 34.2)
Waist, cm 108.3
(106.6 to 110.0)
104.0
(102.3 to 105.7)
103.2
(101.4 to 105.0)
103.7
(101.9 to 105.6)
108.3
(106.6 to 110.0)
103.4
(101.7 to 105.1)
102.0
(100.1 to 103.9)
102.7
(100.8 to 104.6)
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); WC, weight change.
a
Baseline values were substituted for any missing measures for the intent-to-treat analysis. For the usual care group, P.001 for time trend compared with baseline except as indicated.
For the 2 intervention groups, P.001 for group time intervention effect compared with usual care (mixed models) except as indicated.
b
P=.002.
c
P=.001.
Table 1. Demographic Characteristics of Study Participants (N = 442)
Intervention Type
Usual Care
(n = 111)
Center-Based
(n = 167)
Telephone-Based
(n = 164)
Age, mean (SD), y 44 (10) 44 (10) 45 (11)
Race/ethnicity, No. (%)
Non-Hispanic white 113 (67.7) 130 (79.3) 83 (74.8)
Hispanic 24 (14.4) 18 (11.0) 18 (16.2)
Black 18 (10.8) 12 (7.3) 8 (7.2)
Other
a
12 (7.2) 4 (2.4) 2 (1.8)
Education, No. (%)
High school 23 (13.8) 14 (8.5) 15 (13.5)
Some college 74 (44.3) 73 (44.5) 42 (37.8)
College graduate 34 (20.4) 40 (24.4) 21 (18.9)
Graduate school 36 (21.6) 37 (22.6) 33 (29.7)
Clinical site, No. (%)
University of Arizona 42 (25.1) 39 (23.8) 29 (26.1)
Kaiser Permanente Center for Health
Research
40 (24.0) 40 (24.4) 25 (22.5)
University of California, San Diego 44 (26.3) 43 (26.2) 30 (27.0)
University of Minnesota 41 (24.6) 42 (25.6) 27 (24.3)
a
Included Native American, Asian American, Pacific Islander, and self-reported mixed or other race/ethnicity.
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pants at follow-up clinic visits be-
tween 18 months and 24 months,
35.9% of center-based (n=60) and
23.8% of telephone-based (n =39) par-
ticipants did not speak with their coun-
selors at all during that interim pe-
riod. On the other end of the spectrum,
24.6% of center-based (n=41) and
39.2% of telephone-based (n =61) par-
ticipants spoke with their counselors
weekly during that period.
In the intent-to-treat analysis using
baseline value substitution (Table 2),
women in the center-based group lost
a mean of 10.1 kg (95% confidence in-
terval [CI], 9.0-11.2 kg) or 10.9% (95%
CI, 9.7%-12.1%) of initial weight by 12
months and maintained an average
weight loss of 7.4 kg (95% CI, 6.1-8.7
kg) or 7.9% (95% CI, 6.5%-9.3%) of ini-
tial weight at 24 months. Participants in
the telephone-based group lost a mean
of 8.5 kg (95% CI, 7.2-9.7 kg) or 9.2%
(95% CI, 7.8%-10.6%) of initial weight
by 12 months and maintained an aver-
age weight loss of 6.2 kg (95% CI, 4.9-
7.6 kg) or 6.8% (95% CI, 5.2%-8.4%) of
initial weight at 24 months. Partici-
pants in the usual care group lost a mean
of 2.4 kg (95% CI, 1.2-3.6 kg) or 2.6%
(95% CI, 1.4%-3.8%) of initial weight at
12 months and maintained a loss of 2.0
kg (95% CI, 0.6-3.3 kg) or 2.1% (95%
CI, 0.7%-3.5%) of initial weight at 24
months (P .001 compared with the in-
tervention groups). We had no a priori
hypothesis regarding differences be-
tween the center-based and telephone-
based intervention groups, and the study
was not powered to identify weight dif-
ferences between these 2 groups. At-
tenuation of weight loss between 12
months and 24 months was 27% in each
intervention group and 17% in the usual
care group (P =.003).
Results from the multiple imputa-
tion intent-to-treat analysis were quali-
tatively similar to those obtained from
the primary analysis (F
IGURE 2). Data
for women for whom weight was mea-
sured (rather than imputed) show
similar differences across the groups
(Table 2).
By study end, more than half in either
intervention group (62% of center-
based [n=103] and 56% [n =91] of tele-
phone-based participants) had a weight
loss of at least 5% compared with 29%
(n=32) of usual care participants
(P .001). More than twice the pro-
portion of participants in the center-
based and telephone-based interven-
tion groups compared with participants
in the usual care group (37% [n=124]
vs 16% [n=18]) had a weight loss of
10% or more of baseline weight at 24
months (P .001).
All 3 study groups showed im-
proved cardiopulmonary fitness at 24
months (54 [95% CI, 53-55] to 49 [95%
CI, 48-50]; P .001) (usual care group
in T
ABLE 3 and intervention groups in
Figure 2. Weight Change by Group by
Multiple Imputation
0
Intervention type
Center-based (n
=
167)
Telephone-based (n
=
164)
Usual care (n
=
111)
18126 24
–4
–2
–6
–8
–10
–12
0
Months
Mean Weight Change, kg
The error bars indicate 95% confidence intervals.
Table 3. Cardiopulmonary Fitness and Psychosocial and Laboratory Measures for the Usual
Care Group
a
Usual Care (n = 111)
Baseline 6 mo 12 mo 24 mo
Cardiopulmonary fitness measures
Step test, No. 111 99 90 93
Heart rate, /30 s 54 (53-56) 49 (47-50) 49 (47-51) 50 (48-52)
P value .001 .001 .001
Psychosocial measures, No. 111 102 98 103
SF-36 Physical QOL 85 (82-87) 83 (80-86) 82 (80-85) 82 (79-85)
P value .21 .07 .18
SF-36 Mental QOL 81 (78-83) 79 (76-82) 78 (74-81) 78 (74-81)
P value .15 .03 .06
Eating Disorder Examination 2.4 (2.2-2.5) 2.4 (2.2-2.6) 2.1 (2.0-2.3) 2.1 (1.9-2.3)
P value .32 .07 .007
Beck Depression Inventory 5.7 (4.7-6.7) 6.0 (4.6-7.5) 6.0 (4.5-7.5) 6.1 (4.6-7.5)
P value .42 .32 .54
Laboratory measures
Blood sample, No. 111 101 94 96
Total carotenoids, µmol/L 1.8 (1.6-1.9) 1.7 (1.6-1.9) 1.8 (1.6-2.0) 1.8 (1.6-2.0)
P value .49 .55 .83
Total cholesterol, mg/dL 200 (194-206) 196 (188-203) 192 (185-199) 186 (176-195)
P value .15 .02 .001
LDL cholesterol, mg/dL 122 (116-128) 127 (122-134) 114 (108-121) 114 (105-122)
P value .12 .03 .02
HDL cholesterol, mg/dL 54 (51-56) 47 (44-49) 55 (52-58) 51 (48-54)
P value .001 .38 .02
Triglycerides, mg/dL 118 (108-129) 108 (97-119) 114 (104-124) 121 (110-133)
P value .07 .49 .42
Leptin, ng/mL 37.3 (34.3-40.1) 31.7 (28.7-34.7) 32.9 (29.4-36.4) 32.7 (29.3-36.1)
P value .001 .006 .001
C-reactive protein, mg/L
b
2.5 (1.4-5.7) 2.8 (1.1-4.7) 2.5 (1.3-5.0) 2.4 (1.1-5.7)
P value .07 .06 .54
Abbreviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein; QOL, quality of life; SF-36, Short Form 36.
SI conversion factors: To convert carotenoids to µg/dL, divide by 0.01863; C-reactive protein to nmol/L, multiply by 9.524;
HDL, LDL, and total cholesterol to mmol/L, multiply by 0.0259; triglycerides to mmol/L, multiply by 0.0113.
a
Values are expressed as mean (95% confidence interval) unless otherwise indicated. The P values represent time trend
compared with baseline.
b
Values expressed as median (interquartile range).
WEIGHT LOSS AND MAINTENANCE PROGRAM IN WOMEN
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Page 5
TABLE 4), but no significant interven-
tion effect was observed. Both interven-
tion groups reported improved physi-
cal (86 [95% CI, 85-88] vs 82 [95% CI,
79-85]; P =.007) and mental (79 [95%
CI, 77-81] vs 78 [95% CI, 74-81];
P =.04) quality of life at 12 months com-
pared with usual care. The Eating Dis-
order Examination Questionnaire global
scores improved from baseline to 24
months in each group (2.3 [95% CI, 2.2-
2.4] at baseline vs 2.1 [95% CI, 2.0-
2.2] at 24 months; P =.007), but there
was no significant intervention effect. An
intervention effect was seen in im-
proved depression scores at 12 months
(5.4 [95% CI, 4.6-6.1] for the interven-
tion groups vs 6.0 [95% CI, 4.5-7.5] for
the usual care group; P =.01) but not at
24 months.
Levels of CRP were reduced more at
trial end in both intervention groups
than in the usual care group (median
of 1.9 mg/L [interquartile range, 1.0-
3.7 mg/L] [Table 4] vs 2.4 mg/L [in-
terquartile range, 1.1-5.7 mg/L]
[Table 3], respectively; P =.003). Total
Table 4. Cardiopulmonary Fitness and Psychosocial and Laboratory Measures for the 2 Intervention Groups
a
Center-Based Intervention (n = 167) Telephone-Based Intervention (n = 164)
Baseline 6 mo 12 mo 24 mo Baseline 6 mo 12 mo 24 mo
Cardiopulmonary fitness measures
Step test, No. 167 163 157 143 164 150 143 139
Heart rate, /30 s 53
(52-55)
47
(46-48)
47
(46-49)
48
(47-49)
55
(53-56)
48
(47-50)
49
(48-50)
49
(47-50)
P value .16 .16 .20 .16 .16 .20
Psychosocial measures, No. 167 164 156 149 164 162 155 150
SF-36 Physical QOL 84
(82-86)
88
(86-90)
88
(86-90)
85
(82-87)
84
(82-87)
85
(82-87)
84
(82-87)
83
(80-86)
P value .01 .007 .40 .01 .007 .40
SF-36 Mental QOL 80
(78-82)
82
(80-85)
83
(80-85)
79
(77-82)
77
(75-80)
81
(78-83)
76
(73-79)
75
(72-79)
P value .008 .04 .35 .008 .04 .35
Eating Disorder Examination 2.3
(2.1-2.4)
2.2
(2.1-2.3)
2.0
(2.1-2.3)
2.0
(1.9-2.2)
2.4
(2.2-2.5)
2.3
(2.1-2.4)
2.2
(2.1-2.4)
2.2
(2.0-2.3)
P value .08 .75 .90 .08 .75 .90
Beck Depression Inventory 6.6
(5.6-7.5)
4.3
(3.5-5.1)
4.6
(3.7-5.5)
5.4
(4.3-6.4)
6.6
(5.7-7.5)
4.9
(4.0-5.8)
6.1
(4.5-7.5)
7.0
(5.7-8.3)
P value .001 .01 .30 .001 .01 .30
Laboratory measures
Blood sample, No. 167 164 158 147 164 161 155 141
Total carotenoids, µmol/L 1.7
(1.6-1.8)
2.4
(2.2-2.5)
2.3
(2.2-2.5)
2.3
(2.1-2.4)
1.7
(1.5-1.8)
2.0
(1.8-2.1)
2.1
(1.9-2.3)
2.0
(1.9-2.2)
P value .001 .001 .001 .001 .001 .001
Total cholesterol, mg/dL 195
(190-201)
187
(181-192)
189
(183-195)
185
(180-190)
194
(189-200)
186
(180-191)
188
(182-193)
181
(176-187)
P value .21 .76 .36 .21 .76 .36
LDL cholesterol, mg/dL 117
(112-122)
120
(114-125)
111
(106-117)
116
(110-122)
114
(110-119)
119
(114-124)
119
(103-114)
110
(104-116)
P value .64 .70 .16 .64 .70 .16
HDL cholesterol, mg/dL 56
(54-59)
46
(44-48)
57
(54-59)
53
(51-56)
57
(55-60)
45
(43-47)
59
(56-61)
55
(53-57)
P value .02 .66 .83 .02 .66 .83
Triglycerides, mg/dL 107
(101-114)
106
(97-115)
104
(97-112)
112
(103-120)
112
(108-129)
106
(98-115)
103
(93-113)
119
(96-141)
P value .29 .96 .69 .29 .96 .69
Leptin, ng/mL 37.9
(35.5-40.3)
23.3
(21.4-25.2)
23.8
(21.6-26.0)
28.4
(25.7-31.1)
38.8
(36.2-41.4)
24.7
(22.5-26.9)
26.1
(23.5-28.5)
30.7
(27.8-33.6)
P value .001 .001 .02 .001 .001 .02
C-reactive protein, mg/L
b
3.0
(1.7-5.9)
2.3
(1.2-4.1)
1.8
(0.9-4.0)
2.1
(1.0-4.1)
3.3
(2.0-5.2)
2.4
(1.4-4.7)
1.8
(1.0-3.8)
1.8
(1.0-3.7)
P value .17 .001 .001 .17 .001 .001
Abbreviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein; QOL, quality of life; SF-36, Short Form 36.
SI conversion factors: To convert carotenoids to µg/dL, divide by 0.01863; C-reactive protein to nmol/L, multiply by 9.524; HDL, LDL, and total cholesterol to mmol/L, multiply by
0.0259; triglycerides to mmol/L, multiply by 0.0113.
a
Values are expressed as mean (95% confidence interval) unless otherwise indicated. The P values represent group time intervention effect compared with usual care (mixed
models).
b
Values expressed as median (interquartile range).
WEIGHT LOSS AND MAINTENANCE PROGRAM IN WOMEN
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Page 6
plasma carotenoids increased more by
study end in the intervention groups
(2.1 µmol/L; 95% CI, 2.0-2.2 µmol/L)
than in the usual care group (1.8
µmol/L; 95% CI, 1.6-2.0 µmol/L)
(P .001). Total cholesterol concen-
tration decreased from a baseline value
of 196 mg/dL (95% CI, 193-199 mg/
dL) to 184 mg/dL (95% CI, 180-188
mg/dL) at 24 months in all 3 study
groups (P .001) but no intervention
effect was observed. Leptin concentra-
tion showed an intervention effect of
24.9 ng/mL (95% CI, 23.3-26.5 ng/
mL) at 12 months compared with the
usual care group level of 32.9 ng/mL
(95% CI, 29.4-36.4 ng/mL) (P .001)
and 29.5 ng/mL (95% CI, 27.6-31.5 ng/
mL) at 24 months vs 32.7 ng/mL (95%
CI, 29.3-36.1 ng/mL), respectively
(P =.02).
COMMENT
Findings from this study suggest that
this incentivized structured weight loss
program with free prepared meals can
effectively promote weight loss com-
pared with the usual care control group.
Importantly, weight loss was largely
maintained at 2-year follow-up. We ob-
served an average 1-year weight loss of
approximately 10% and an average
2-year weight loss of approximately 7%
in response to the weight loss pro-
gram intervention, which is a degree of
weight reduction that has been shown
to significantly reduce the risk of dia-
betes and cardiovascular disease risk
factors in large randomized stud-
ies.
24,25
The low dropout rate and small
amount of missing data in our study
minimize ambiguity in drawing infer-
ences. For clinical practitioners, the evi-
dence suggests that the structured pro-
gram as applied in this study provides
another route for their overweight or
obese patients to achieve and main-
tain weight loss through behavioral
changes for at least a 2-year period.
Moreover, several components of this
structured program have been inde-
pendently observed to promote weight
loss and the maintenance of weight loss,
including person-to-person behav-
ioral counseling,
9
low-energy density
diet,
26
prepackaged foods,
27,28
and in-
creased physical activity.
29
In a randomized controlled trial of
another US weight loss program
(N=423), Heshka et al
11
reported an av-
erage weight loss of 4.6% at 1 year and
3.1% at 2 years in the group assigned
to that program in a last observation
carried forward intent-to-treat analy-
sis. Results also can be compared with
the Diabetes Prevention Program study
(N=3234), in which participants as-
signed to the intensive lifestyle inter-
vention group achieved an average
weight loss of 5.6 kg (5.9% of weight)
at 2.8 years.
25
In the Look AHEAD (Ac-
tion for Health in Diabetes) study
(N=5145), a weight loss and physical
activity intervention that included liq-
uid meal replacements and the option
of weight loss medications, an average
weight loss of 8.6% of initial weight
at 1 year and 4.7% at 4 years was
achieved.
24,30,31
In our small, single-site pilot study
(N=70) for this trial, we compared the
effect of the center-based intervention
with a usual care group to provide data
for power calculations. In that study,
baseline value substitution intent-to-
treat analysis showed an average 12-
month weight loss of 7.1% of initial
weight in the intervention group.
12
Findings from the present trial pro-
vide further evidence for the effective-
ness of the center-based intervention
across several geographical regions and
centers in a larger sample, but also pro-
vide new information about the effec-
tiveness of the telephone-based inter-
vention.
The improvement in levels of high-
sensitivity CRP in the intervention
groups reflects the effect of weight loss
on this inflammatory marker.
32
A dif-
ferential lipid response was not ob-
served across the study groups despite
differing degrees of weight loss. Nota-
bly, the women in this study sample
were generally not dyslipidemic. As pre-
viously observed, high-density lipopro-
tein cholesterol often is reduced in re-
sponse to initial weight loss but
rebounds at later time points.
33
The in-
crease in plasma carotenoids (a marker
of vegetable and fruit intake) in par-
ticipants in the intervention groups is
an important indicator of diet quality
as well as energy density of the diet.
34-36
In contrast with some other weight loss
programs, this structured weight loss
program uses foods in prepackaged
meals and snacks to facilitate a struc-
tured meal plan rather than a compos-
ite formula beverage. This strategy re-
sults in a dietary pattern associated with
reduced risk for cardiovascular dis-
ease and stroke.
37-39
There are several limitations of this
study. First, as a proof-of-principle
study, the purpose was to determine
whether the program is effective in pro-
moting weight loss and weight loss
maintenance so the intervention and
prepackaged foods were provided
without cost to the participants. For
paying patients in this structured com-
mercial program, enrollment fees for a
year-long premium program are $359,
plus the cost of food. In the United
States, the cost of program-provided
foods for a 7-day menu of prepared
foods averages $100 per week. The av-
erage cost varies due to personal tastes,
incidence of dining out, travel, and
phase of the program. The menu is
supplemented with fruits, vegetables,
and dairy foods at an approximate cost
of $20 to $25 per week. For the first year
of the program, participant food costs
would have averaged $85 per week for
a total of $4080 for the year. For the sec-
ond year of the program, when partici-
pants transitioned to their own foods,
food costs would have averaged $45 per
week for a total of $2160 for the year.
This compares with data from the Con-
sumer Expenditure Survey, which es-
timates that US consumers typically
spend $124 per week on food.
40
Thus, a major issue is the generaliz-
ability of these findings to the average
patient. The results may be related in
part to the economic benefits to the par-
ticipants of providing food, as well as
reimbursement for participating in
clinic visits, and the low dropout rate
in this study contrasts with the high at-
trition rates reported among weight loss
program cohorts.
41-43
WEIGHT LOSS AND MAINTENANCE PROGRAM IN WOMEN
©2010 American Medical Association. All rights reserved. (Reprinted) JAMA, October 27, 2010—Vol 304, No. 16 1809
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Page 7
Second, individuals who agree to par-
ticipate in a randomized controlled trial
are likely to be a highly motivated sub-
set of the population. Third, the weight
loss program counselors were un-
blinded, which may have influenced
their behavior and effectiveness, al-
though they were instructed to pro-
vide the program and services as de-
signed to be delivered to paying
customers. Fourth, the control group
in this study was provided an interven-
tion that would be a likely first step for
the overweight or obese individual seek-
ing guidance for weight loss and could
be covered by health insurance, so dis-
parate intensity in the intervention and
control groups also likely influenced the
findings. Some attenuation of the pro-
gram effects may occur over time, al-
though the improvement in cardiopul-
monary fitness suggests that
participants are maintaining higher lev-
els of physical activity, which is asso-
ciated with better maintenance of
weight loss.
44
Person-to-person behavioral coun-
seling interventions involving fre-
quent contact are associated with op-
timal weight loss, although these are
difficult to incorporate into medical
practice.
9
With scientific evidence for
efficacy, such weight loss programs may
be appropriate to include in health care
systems and/or employer health pro-
motion initiatives.
In summary, results from this study
suggest that a free prepared meals and
incentivized structured weight loss pro-
gram that promotes diet and lifestyle
modification successfully facilitated
weight loss and weight loss mainte-
nance compared with a control group.
Program participation promoted favor-
able changes in biological factors asso-
ciated with risk for cardiovascular dis-
ease. Health care practitioners, when
applying these findings to the care of
the average patient, also may note that
effectiveness likely relates to motiva-
tion and adherence.
Published Online: October 9, 2010. doi:10.1001
/jama.2010.1503
Author Affiliations: School of Medicine, University of
California, San Diego, and Moores UCSD Cancer Cen-
ter, La Jolla, California (Drs Rock and Pakiz and Ms
Flatt); HealthPartners Research Foundation and Divi-
sion of Epidemiology and Community Health, School
of Public Health, University of Minnesota, Minneapo-
lis (Dr Sherwood); Kaiser Permanente Center for Health
Research, Portland, Oregon (Dr Karanja); and Ari-
zona Cancer Center, Department of Nutritional Sci-
ences, University of Arizona, Tucson (Dr Thomson).
Author Contributions: Dr Rock had full access to all
of the data in the study and takes responsibility for
the integrity of the data and the accuracy of the data
analysis.
Study concept and design: Rock, Pakiz.
Acquisition of data: Flatt, Sherwood, Karanja, Pakiz,
Thomson.
Analysis and interpretation of data: Flatt, Sherwood,
Karanja, Pakiz, Thomson.
Drafting of the manuscript: Rock, Flatt, Karanja,
Thomson.
Critical revision of the manuscript for important in-
tellectual content: Rock, Flatt, Sherwood, Karanja,
Pakiz.
Statistical analysis: Rock, Flatt.
Obtained funding: Rock, Pakiz.
Administrative, technical, or material support: Flatt,
Sherwood, Karanja, Pakiz.
Study supervision: Rock, Sherwood, Karanja, Pakiz,
Thomson.
Financial Disclosures: Dr Rock reported serving on the
advisory board for Jenny Craig from 2003-2004. None
of the other authors reported any financial disclo-
sures.
Funding/Support: This study was supported by Jenny
Craig Inc (Carlsbad, California), which provided pro-
gram activities, materials, and prepackaged foods to
individuals assigned to the commercial weight loss pro-
gram. Funding was provided through a clinical trial con-
tract to the coordinating center (School of Medicine,
University of California, San Diego), which subse-
quently disbursed funds to the collaborating clinical
sites and the laboratories. Data from the clinical sites
and the laboratories were forwarded to the coordi-
nating center where they were pooled for analysis.
Role of the Sponsor: Jenny Craig Inc had a minimal
role in the design and protocol development. By con-
tractual agreement, scientists at the University of Cali-
fornia, San Diego, and the other participating insti-
tutions had responsibility and independence regarding
data management, analysis, and publication. The fund-
ing sponsor had no role in the collection, analysis, or
interpretation of the data; or in the preparation, re-
view or approval of the manuscript.
Independent Statistical Analysis: Shirley W. Flatt, MS,
a senior statistician at the University of California, San
Diego, performed the statistical analysis with consul-
tation provided by Loki Natarajan, PhD, a faculty bio-
statistician.
Data and Safety Monitoring Committee: Ken Fu-
jioka, MD, Karen Messer, PhD, and Kevin Patrick, MD.
Additional Contributions: We thank the data and safety
monitoring committee and also acknowledge Dennis
Heath, MS, Mila Pruitt, and Paul Mills, PhD (all with
the University of California, San Diego), and Russell
Tracy, PhD (University of Vermont), for conducting the
laboratory assays; Christine Zoumas-Morse, MS, RD
(University of California, San Diego), for managing the
project; Annie Hotop, MA, MS (University of Minne-
sota), Lucy Fulton, DTR (Kaiser Permanente Center for
Health Research), Jennifer Ravia, MS, and Emily Nardi,
MPH, RD (University of Arizona), and Elizabeth Quin-
tana, MS, RD (University of California, San Diego), for
coordinating activities at the clinical sites; and Lea Ja-
cinto, BS (University of California, San Diego), for as-
sistance with administrative support and manuscript
preparation. All of these individuals and laboratories were
compensated for their labor and contributions through
the clinical trial contract.
Additional Information About Trial Registration: The
clinical trials registry was initiated by the investiga-
tors in early November 2007, before any patient en-
rollment. When informed at that time that this was a
responsibility of the industry sponsor, the responsi-
bility of completing the registration process was re-
assigned. The registration was in process until March
2008, when it was finalized. The delay was not pur-
poseful and is attributable to inexperience and per-
sonnel support limitations. This had no effect on screen-
ing, recruitment, enrollment, and management of study
participants due to the limited number of geographi-
cal sites involved, exclusion and inclusion criteria, and
a relatively small total sample size compared with other
large-scale population-based clinical trials.
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    • "The validated questionnaires that are being used to assess the safety and efficacy of the program are designed to evaluate whether the program can nurture positive outcomes rather than facilitate harmful behaviours. Commercial programs are currently available within the community and have demonstrated to be successful in an adult population [15, 17]. Such programs have the resources to provide ongoing, long term support that is not always provided by health professionals in primary care due to restraints on time and patient load [20]. "
    [Show abstract] [Hide abstract] ABSTRACT: Early lifestyle intervention with overweight and obese adolescents could help to avoid serious health events in early adulthood, ultimately alleviating some of the strain on the public health system due to obesity-related morbidity. Commercial weight loss programs have wide reach into the community setting, and have demonstrated success in long term weight management in adults, beyond that of current public health care. Commercial weight-management programs have not been evaluated as a method of delivery for overweight and obese adolescents. This study aims to evaluate the efficacy of a new adolescent weight management program in a commercial environment. One hundred and forty adolescents, 13 to 17 years old, will be randomised to either a weight management program intervention or a wait-listed group for 12 weeks. The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability. Participants will be overweight or obese (above the 85(th) percentile for BMI) and without existing co-morbidities. Outcome measures will be assessed at baseline and after 12 weeks. Primary outcome measures will be changes in BMI Z-score and waist-height ratio. Secondary outcome measures will include changes in behaviour, physical activity and psychosocial wellbeing. Intervention participants will be followed up at 6 months following completion of the initial program. Ethics approval has been granted from the Monash University Human Research Ethics Committee (CF11/3687-2011001940). This independent evaluation of a weight management program for adolescents, delivered in a commercial setting, will provide initial evidence for the effectiveness of such programs; which may offer adolescents an avenue of weight-management with ongoing support prior to the development of obesity related co-morbidities. The protocol for this study is registered with the International Clinical Trials Registry ISRCTN13602313 .
    Full-text · Article · Jun 2015 · BMC Public Health
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    • "It is indeed possible to have a high follow-up as seen in a recently published weight loss trial of free meals and an intensive weight loss program. After 24 months the investigators had weight data on 92% of the study participants [20]. If participants don't attend the last visit, one might also contact them by phone and ask them to use their own scale at home. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: In randomised trials of medical interventions, the most reliable analysis follows the intention-to-treat (ITT) principle. However, the ITT analysis requires that missing outcome data have to be imputed. Different imputation techniques may give different results and some may lead to bias. In anti-obesity drug trials, many data are usually missing, and the most used imputation method is last observation carried forward (LOCF). LOCF is generally considered conservative, but there are more reliable methods such as multiple imputation (MI). Objectives: To compare four different methods of handling missing data in a 60-week placebo controlled anti-obesity drug trial on topiramate. Methods: We compared an analysis of complete cases with datasets where missing body weight measurements had been replaced using three different imputation methods: LOCF, baseline carried forward (BOCF) and MI. Results: 561 participants were randomised. Compared to placebo, there was a significantly greater weight loss with topiramate in all analyses: 9.5 kg (SE 1.17) in the complete case analysis (N = 86), 6.8 kg (SE 0.66) using LOCF (N = 561), 6.4 kg (SE 0.90) using MI (N = 561) and 1.5 kg (SE 0.28) using BOCF (N = 561). Conclusions: The different imputation methods gave very different results. Contrary to widely stated claims, LOCF did not produce a conservative (i.e., lower) efficacy estimate compared to MI. Also, LOCF had a lower SE than MI.
    Full-text · Article · Nov 2014 · PLoS ONE
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    • "While existing evidence indicates that weight loss at any age is difficult to achieve and sustain, successful programs for women in their reproductive years reaffirm that women can overcome environmental pressures like easy access to low-cost, high-calorie foods and develop healthy eating habits. These programs promote dietary modification and increased physical activity through sustained daily changes, with the help of a support system and regular monitoring [28-36]. Women should be encouraged to include moderate physical activity in their daily routine to improve weight and cardiovascular status before pregnancy and reduce the likelihood of developing weight-related complications during gestation [37]. "
    [Show abstract] [Hide abstract] ABSTRACT: Providing care to adolescent girls and women before and between pregnancies improves their own health and wellbeing, as well as pregnancy and newborn outcomes, and can also reduce the rates of preterm birth. This paper has reviewed the evidence-based interventions and services for preventing preterm births, reported the findings from research priority exercise, and prescribed actions for taking this call further. Certain factors in the preconception period have been shown to increase the risk for prematurity and, therefore, preconception care services for all women of reproductive age should address these risk factors through preventing adolescent pregnancy, preventing unintended pregnancies, promoting optimal birth spacing, optimizing pre-pregnancy weight and nutritional status (including a folic acid-containing multivitamin supplement) and ensuring that all adolescent girls have received complete vaccination. Preconception care must also address risk factors that may be applicable to only some women. These include screening for and management of chronic diseases, especially diabetes; sexually-transmitted infections; tobacco and smoke exposure; mental health disorders, notably depression; and intimate partner violence. The approach to research in preconception care to prevent preterm births should include a cycle of development and delivery research that evaluates how best to scale up coverage of existing evidence-based interventions, epidemiologic research that assesses the impact of implementing these interventions and discovery science that better elucidates the complex causal pathway of preterm birth and helps to develop new screening and intervention tools. In addition to research, policy and financial investment is crucial to increasing opportunities to implement preconception care, and rates of prematurity should be included as a tracking indicator in global and national maternal child health assessments.
    Full-text · Article · Nov 2013 · Reproductive Health
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