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www.thelancet.com/lancetgh Vol 5 October 2017 e
1004
Articles
Lancet Glob Health 2017;
5: e1004–16
See Comment page e955
Ekjut, Chakradharpur,
Jharkhand, India (N Nair MBBS,
P Tripathy MSc, H Pradhan MDS,
R Gope PGDRD, S Gagrai BA,
Sh Rath MA, Su Rath MA,
R Sinha PhD, S Sarbani Roy MSc,
S Shewale MSc, V Singh BA);
Sitaram Bhartia Institute of
Science and Research,
New Delhi, India
(H S Sachdev FRCPCH); Public
Health Foundation of India,
New Delhi, India
(S Bhattacharyya PhD,
A Srivastava PhD); and
Institute
for Global Health, University
College London, London, UK
(A Costello FRCP, A Copas PhD,
J Skordis-Worrall PhD,
H Haghparast-Bidgoli PhD,
N Saville PhD, A Prost PhD)
Correspondence to:
Dr Audrey Prost, Institute for
Global Health, University College
London, London, UK
Audrey.prost@ucl.ac.uk
Effect of participatory women’s groups and counselling
through home visits on children’s linear growth in rural
eastern India (CARING trial): a cluster-randomised
controlled trial
Nirmala Nair, Prasanta Tripathy, H S Sachdev, Hemanta Pradhan, Sanghita Bhattacharyya, Rajkumar Gope, Sumitra Gagrai, Shibanand Rath,
Suchitra Rath, Rajesh Sinha, Swati Sarbani Roy, Suhas Shewale, Vijay Singh, Aradhana Srivastava, Anthony Costello, Andrew Copas,
Jolene Skordis-Worrall, Hassan Haghparast-Bidgoli, Naomi Saville, Audrey Prost
Summary
Background Around 30% of the world’s stunted children live in India. The Government of India has proposed a new
cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the eect of such a
worker carrying out home visits and participatory group meetings on children’s linear growth.
Methods We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India.
120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery.
Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1–2, or ≥3),
resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of
pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well
as monthly women’s group meetings to promote individual and community action for nutrition. Participants were
pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal
deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant
pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in
pregnancy, within 72 h of her baby’s birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was
children’s length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the
intervention, participants and the intervention team were not masked to allocation. Data collectors and the data
manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry
of India (number 2014/06/004664).
Results Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant
women recruited between Oct 1, 2013, and Feb 10, 2015, and were therefore eligible for follow-up (1460 assigned to
intervention; 1541 assigned to control). Three groups of children could not be included in the final analysis:
147 migrated out of the study area (67 in intervention clusters; 80 in control clusters), 77 died after the neonatal period
and before 18 months (31 in intervention clusters; 46 in control clusters), and seven had implausible length-for-age
Z scores (<–5 SD; one in intervention cluster; six in control clusters). We measured 1253 (92%) of 1362 eligible
children at 18 months in intervention clusters, and 1308 (92%) of 1415 eligible children in control clusters. Mean
length-for-age Z score at 18 months was –2·31 (SD 1·12) in intervention clusters and –2·40 (SD 1·10) in control
clusters (adjusted dierence 0·107, 95% CI –0·011 to 0·226, p=0·08). The intervention did not significantly aect
exclusive breastfeeding, timely introduction of complementary foods, morbidity, appropriate home care or care-
seeking during childhood illnesses. In intervention clusters, more pregnant women and children attained minimum
dietary diversity (adjusted odds ratio [aOR] for women 1·39, 95% CI 1·03–1·90; for children 1·47, 1·07–2·02), more
mothers washed their hands before feeding children (5·23, 2·61–10·5), fewer children were underweight at 18 months
(0·81, 0·66–0·99), and fewer infants died (0·63, 0·39–1·00).
Interpretation Introduction of a new worker in areas with a high burden of undernutrition in rural eastern India did
not significantly increase children’s length. However, certain secondary outcomes such as self-reported dietary
diversity and handwashing, as well as infant survival were improved. The interventions tested in this trial can be
further optimised for use at scale, but substantial improvements in growth will require investment in nutrition-
sensitive interventions, including clean water, sanitation, family planning, girls’ education, and social safety nets.
Funding UK Medical Research Council, Wellcome Trust, UK Department for International Development (DFID).
Copyright © The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
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Introduction
An estimated 23% of the world’s children are stunted (too
short for their age) because of chronic under nutrition.1
Growth faltering, which leads to stunting, is fastest
between conception and 2 years, or the first 1000 days of
life.2 Stunting endangers subsequent physical and
cognitive development, is linked to poor health and low
earnings in adulthood, and contributes to the
intergenerational transmission of poverty.3 Interventions
to promote children’s growth have the potential to increase
survival and school attainment, oer protection against
adult chronic disease, and bolster human development.3
WHO’s Global Strategy for Women’s, Children’s and
Adolescents’ Health and the second Sustainable
Development Goal call for urgent action to reduce the
number of children who are stunted by 40% by 2025.4
There is substantial agreement about the determinants
of stunting and interventions to address it, but insucient
operational research for strategies to increase the coverage
of these interventions in high-burden settings. The Lancet’s
2013 Maternal and Child Nutrition Series recommends
ten nutrition-specific interventions, including sucient
and diverse foods for adolescent girls and women; iron,
folic acid, and calcium supplementation in pregnancy;
good infant and young child feeding practices; vitamin A,
iron, and preventive zinc supplementation for children;
and treatment for moderate and severe acute malnutrition.5
Strikingly however, expanding the coverage of these
nutrition-specific interventions to 90% of mothers and
children would only reduce stunting by an estimated
20%.5 Larger reductions than these require increasing
access to family planning, health services for pregnant
women and children, investments in water and sanitation,
social safety nets, girls’ education, and women’s empower-
ment.6 A pragmatic approach to design community
strategies for stunting reduction might therefore be to
Research in context
Evidence before this study
Systematic reviews have examined the independent effects of
breastfeeding promotion, complementary feeding education,
prenatal and postnatal food and micronutrient
supplementation, psychosocial stimulation, as well as water,
sanitation, and hygiene interventions on height-for-age Z score
or length-for-age Z score among children younger than 5 years
in low-income and middle-income countries. All found either
small (<0·25 SD) or null effects on height-for-age Z score or
length-for-age Z score, leading to calls for combining some or
all of these interventions, and an increased focus on
nutrition-sensitive interventions.
We did a systematic review of studies testing the effects of
interventions integrating combinations of infant and young
child feeding promotion, hygiene through handwashing with
soap, prevention and care-seeking for childhood illnesses, and
psychosocial stimulation on height-for-age Z score or
length-for-age Z score among children younger than 2 years in
South Asia. We did the review before the start of the
intervention in 2013, and updated it on March 6, 2017. We
searched for randomised controlled trials published between
Oct 1, 2000, and March 6, 2017, in English in Embase, MEDLINE,
and PsycINFO using the terms “growth”, “stunting”,
“height-for-age”, and “length-for-age” in the abstract field.
We excluded studies with only severely acutely malnourished
children, very low birthweight infants, exclusively formula-fed
infants, and those that only measured the length of infants
younger than 6 months. Our search yielded 2775 records,
from which we identified six relevant trials of moderate-to-good
quality from south Asia. In the appendix, we describe these trials
and offer a risk assessment. All trials tested the effects of
education and coaching on infant and young child feeding
practices, including responsive feeding and handwashing. Four
trials tested the effect of combining psychosocial stimulation
with nutrition education and two trials combined nutrition
education and stimulation with multiple micronutrient powder
supplementation. All six trials showed either null or small effects
on height-for-age Z score, length-for-age Z score, or attained
length, suggesting that combinations of nutrition-specific,
stimulation and hygiene promotion interventions are unlikely
to lead to substantial gains in linear growth.
Added value of this study
To our knowledge, our study was the first to test an integrated
community strategy to promote maternal nutrition, infant and
young child feeding, hygiene, prevention and care-seeking for
childhood illnesses, and stimulation in rural India. The 0·11 SD
effect of the intervention on length-for-age Z score (an
estimated 0·25cm gain in length) was greater than that found
in other trials of combined interventions, but still small and
non-significant at the 0·05 level.
Implications of all the available evidence
Scaling up of nutrition-specific actions, hygiene promotion and
responsive stimulation in high-burden settings is crucial to
improving children’s growth and development. To our
knowledge, our combined intervention is the only to date to
test the effect of introducing a worker proposed by the Indian
Government for rural districts with a high burden of
undernutrition, and found effects on self-reported dietary
diversity, handwashing, and infant mortality. Further
operational research should focus on optimising materials
developed in this and other studies for use with accredited
social health activists as part of the Mother’s Absolute Affection
programme and the scale up of participatory learning and
action with women’s groups in ten states. Achieving the
40% reduction in stunting envisioned by WHO’s Global Strategy
for Women’s, Children’s, and Adolescents’ health will require
investment in nutrition-sensitive interventions including clean
water, sanitation, family planning, girls’ education, and social
safety nets.
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prioritise action on immediate determinants (infection
control, nutrition, and care in the first 1000 days) while
providing an enabling social environment for changes in
more distal determinants, for example by sharing
information about health, nutrition, and sanitation
entitlements, and bolstering women’s agency.
India is home to around 30% of the world’s stunted
children.7 38% of Indian children are too short for their
age.8 The Government’s Integrated Child Development
Services (ICDS) and National Health Mission seek to
increase the coverage of interventions to promote growth
in the first 1000 days of life but face substantial barriers.
ICDS’ main cadre, the Anganwadi worker, has a workload
described by a 2011 Government of India report as
“humanly impossible”.9 She is asked to provide food
supplementation to pregnant women and children aged
6 months to 6 years, monitor the growth of all children
younger than 5 years monthly, refer undernourished
women and children to health and nutrition services,
provide health and nutrition education, support
immunisations, and oer preschool education to children
aged 3–6 years in a catchment area of 1000 population, all
within a 4–5 h working day and for INR3000 (US$44) a
month.9 India’s 12th National Plan (2012–17) proposed a
second Anganwadi worker to promote growth among
children younger than 3 years in 200 high-burden
districts, but no evidence-based, rigorously tested
intervention model for such a worker currently exists.10
Previous trials11–23 of community interventions to reduce
undernutrition have either been done outside India,
tested single health, nutrition, or hygiene interventions
rather than integrated strategies, did not focus on the
1000 days period, or did not look at the eects on
children’s length.
We aimed to determine whether a strategy involving a
new worker doing home visits and participatory women’s
group meetings could improve maternal nutrition, as
well as feeding, hygiene, care, and stimulation practices
for children, and through this, lead to an increase in
children’s linear growth.
Methods
Study design and setting
We did a cluster-randomised controlled trial in West
Singhbhum and Kendujhar, two adjoining rural districts of
Jharkhand and Odisha in eastern India. 48% of children
younger than 5 years in rural Jharkhand are stunted, and
35% in rural Odisha.8 More than 80% of families in West
Singhbhum and Kendujhar live in rural areas, and around
40% are from indigenous (adivasi) communities. Less than
50% of women are literate, and less than 10% of households
have access to a toilet facility.24
Within each of the two districts, we identified
120 geographical clusters with a population of around
1000 people each to approximate the catchment area of
an Anganwadi worker. The trial area covered an estimated
total population of 121 531 people. Each cluster included a
village and any adjoining hamlets, and was separated
from others by natural boundaries (eg, rivers, hills) or
distance. We sought written consent from village leaders
for the participation of clusters before randomisation.
Intervention and control clusters had not been previously
exposed to community interventions with participatory
groups or home visits, including those tested in previous
studies.25
Participants
Individual participants were pregnant women identified
and recruited in the study clusters and their children.
Community-based, incentivised volunteers identified
women in the third trimester of pregnancy. 30 female
data collectors (one per 4000 population) with 10–12 years
of education verified these identifications, approached
each pregnant woman to explain the study, and sought
written consent for participation. Data collectors then
visited each woman in pregnancy, within 72 h of her
baby’s birth, and at 3, 6, 9, 12, and 18 months after birth.
We continued to identify pregnant women until
Dec 31, 2015, to measure the eect of the intervention on
maternal nutrition in pregnancy, although we did not
follow up these mothers’ children. We sought women’s
individual informed consent in writing or by thumbprint
during the enrolment interview in pregnancy, and
verbally before all subsequent interviews.
We excluded stillbirths and neonatal deaths, infants
whose mothers died, those with congenital abnormalities,
multiple births, and mother and infant pairs who
migrated out of the study area permanently during the
trial period. Permanent migrants were defined as those
missing two consecutive interviews and the final
interview at 18 months, or missing interviews at 12 and
18 months. Migration was assumed to have occurred at
the point of the earliest missed consecutive interview.
Data collectors attempted to find each mother at least
three times at each follow-up.
Ekjut, a civil society organisation working to improve
health in rural indigenous communities of eastern India
since 2002, led the intervention and data collection. The
trial protocol was reviewed and approved by the research
ethics committee of the Public Health Foundation of
India (June, 2013, TRC-IEC-163/13), an Independent
Ethics Committee linked to Ekjut (May, 2013, reference
IEC/EKJUT/01), and University College London’s
Research Ethics Committee (June, 2013, reference
1881/002). The study was overseen by a trial steering
committee of three members and by a data monitoring
committee of five members with expertise in paediatrics,
nutritional epidemiology, and statistics. Both committees
met annually. For ethical reasons, severely acutely
malnourished children identified by data collectors in
both trial arms were referred to local malnutrition
treatment centres. When parents refused to take children
to the local malnutrition treatment centre, local village
health sanitation and nutrition committee members
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were requested to follow up and ensure that they were
admitted to local malnutrition treatment centres.
Procedures
Data collectors measured children’s length using Shorr
boards (Olney, MD, USA), their weight using Tanita
BD-590 scales (Mumbai, India), and their mid-upper
arm circumference using tapes from UNICEF. They also
measured mothers’ height using Seca 213 stadiometers,
their weight with Seca 874 scales, and mid-upper arm
circumference using Seca 212 tapes. Data collectors
received 9 days of training on anthropometry and
questionnaire administration, and had fortnightly
review meetings. We did two anthropometry
standardisation exercises with 2660 children aged
6–24 months before the start of data collection, and
another 12 months into data collection. We calculated
technical error of measurement (TEM) and coecients
of reliability (R) for length, weight, and mid-upper arm
circumference.26 R for length was 0·98 before data
collection and 0·99 1 year later. Data collectors used
smartphones to collect data. Supervisors observed 11%
of measurements and interviews. We documented
dietary practices using 24-h recall through interviews
with all mothers or caregivers, and classified food groups
using the most recent Food and Agriculture Organization
guidelines for the measurement of women’s and
children’s dietary diversity.27 Hygiene practices,
including handwashing with soap, were assessed using
self-reports. The data manager checked the number of
interviews completed every week to identify and address
possible problems, and downloaded data every 2 weeks
to check for errors using automated Do-files and
Stata 13 software.
Randomisation and masking
Randomisation took place in July, 2013, and was
stratified by district and number of hamlets per cluster
(0, 1–2, or ≥3), resulting in six strata. For transparency,
we invited village leaders, front-line health workers and
members of local governance bodies to participate in
a randomisation meeting. Meeting participants put
numbered balls corresponding to clusters in each
stratum in a local tombola (lottery device), then
sequentially allocated each ball (cluster) to the
intervention or control arms. Due to the nature of the
intervention, participants and the intervention team
were not masked to allocation. The data collection team
and data manager were masked to allocation.
Intervention and data collection teams met on dierent
days, and had dierent team leaders.
Intervention
In the intervention arm, we recruited 60 new female
community-based workers called Su-Poshan Karyakarta
(SPK), meaning good nutrition worker, in consultation
with local village health sanitation and nutrition
committees and existing Anganwadi workers. Each SPK
worked in her own village and any nearby hamlets, and
covered around 1000 people. She had a minimum of
10 years’ schooling, was married, preferably from a
tribal community, and was paid a monthly stipend of
Figure 1: A village-level view of the community intervention strategy
MUAC=mid-upper arm circumference.
Su-Poshan Karyakarta (SPK)
• Working in her own village and neighbouring hamlets
Monthly activities:
• Conducts 2–3 women’s group meetings
• Attends 2 fortnightly review meetings
• Visits pregnant women once, and all children younger than
2 years monthly
Children with MUAC ≥125 mm
• If ill, counsels and refers to health provider
• If not ill, counsels mother on feeding, infection control, and
caregiving and invites her to women’s group
Children with MUAC ≥115 mm and
<125 mm
Anganwadi worker
• Gives supplementary food
• Monitors children’s growth
• Participates in selection of SPK
• If ill, counsels and refers to health provider
• If not ill, counsels mother, encourages her to use Take Home
Ration and Invites her to women’s group
Children with MUAC <115 mm or
bilateral pitting oedema or both
Refers to Anganwadi for admission to malnutrition
treatment centre
Malnutrition treatment centre
Treats severely acutely malnourished children
• SPK visits all pregnant women in
third trimester once
• Visits all 45–50 children younger than
2 years monthly, measures MUAC
• Counsels and refers as appropriate
Women’s groups
SPK supports
groups through a cycle of
participatory learning and
action meetings focused on
health and nutrition in
pregnancy and the first
2 years of life
Home visit
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INR3000, equivalent to that of existing Anganwadi
workers at the time of the study. Six supervisors
recruited by the study team supported ten SPKs each,
mirroring the ICDS supervision structure. The SPK’s
programme of work was designed not to have overlap
with the Anganwadi and accredited social health
activists’ tasks. SPKs and supervisors received 14 days of
training during the intervention period, and attended
supervision meetings twice a month.
The SPK was responsible for two main activities:
conducting a single home visit to each pregnant woman
in the third trimester of pregnancy for counselling on
maternal nutrition, followed by monthly home visits to
all children younger than 2 years with counselling
for growth promotion; and the facilitation of
two to three participatory meetings with local women’s
groups per month (the exact number depended on the
size of her working area and number of hamlets;
figure 1). Home visits sought to address immediate
causes of undernutrition through counselling for infant
and young child feeding practices, illness prevention,
and support for referrals in case of illness or acute
malnutrition. Participatory group meetings reinforced
actions linked to immediate causes and began to
address underlying causes of undernutrition, including
birth spacing, nutrition in pregnancy, water, sanitation,
and women’s agency.
Before home visits, the SPK gathered the names and
location of all pregnant women and children younger
than 2 years in her working area from the local Anganwadi
worker and members of pre-existing women’s groups. At
each visit to a mother and child pair, she asked about
current or recent illness, took a mid-upper arm
circumference measurement for children older than
6 months, and engaged the mother in a discussion about
feeding, hygiene, care (defined here as care-seeking for
illnesses and oering more food or breastmilk during
and after illness), and stimulation. This began with the
mothers’ immediate concerns with illness, feeding, and
care. The SPK used age-appropriate picture cards that
depicted good practices and contained key
recommendations adapted from the Essential Nutrition
Action counselling materials and the Care for
Development WHO module about stimulation for early
childhood development. She provided information about
preventive and care-seeking practices, encouraged the
mother to try new practices (eg, new complementary food
recipes), demonstrated practices (eg, handwashing, food
enrichment, and stimulation), and sought to persuade
mothers and other caregivers to adopt them (appendix
p 2). Mid-upper arm circumference measurement was
used to guide referrals (figure 1).
The SPKs also facilitated a cycle of 29 participatory
meetings with women’s groups. These monthly
meetings targeted pregnant women and mothers of
children younger than 2 years and adolescent girls, but
were open to all community members. The groups
followed a four-phase participatory learning and action
cycle in which they: assessed the health and nutrition
situation in their community; decided on actions to
take; took action; and evaluated the process (appendix p
5). In the first phase, the SPK described the
intergenerational cycle of undernutrition using
pictures. She encouraged group participants to discuss
local practices associated with undernutrition using a
picture card game to identify health, nutrition, and
care-related problems. Group participants were then
invited to prioritise the problems they wanted to
address by voting using the picture cards. In the second
phase of the cycle, groups explored the causes of their
prioritised problems by listening to stories created by
the SPKs using local themes. Stories illustrated how
problems were linked with underlying household,
community, and health service-related factors.
Participants decided which of these underlying causes
to address, and how. They allocated responsibilities for
each strategy and planned a community meeting to
share their plans with others and enlist their support.
In the third phase, group participants implemented
their strategies, and the SPK introduced them to further
practical activities, including how to enhance the
density and diversity of complementary foods using
local products and toy-making for children. In the
fourth phase, group participants reviewed their
achievements, diculties, and evaluated individual
meetings. Village health sanitation and nutrition
committees are composed of elected members of the
Panchayat (local governance body), front-line health
and nutrition workers, service users (especially
mothers), and members from key community
subgroups. The committee’s role is to monitor access to
essential public services, organise local collective action
for health promotion, facilitate service delivery in the
village and hamlets, make a village health plan, and
monitor the quality of local health facilities. In both
intervention and control clusters, Ekjut coordinators
held five participatory meetings with village health
sanitation and nutrition committees in between the
committees’ regular monthly meetings for 2 years as a
minimum common benefit to villages in both trial
arms. Meetings aimed to strengthen the capacity of
village health sanitation and nutrition committees to
assess community health needs, prepare and
implement village health plans, and monitor the
provision of local health and nutrition services. This
was the only activity implemented in control clusters
besides routine government services.
Outcomes
The trial’s primary outcome was children’s mean
length-for-age Z scores at 18 months. Secondary
outcomes included wasting and underweight at all
timepoints, birthweight, growth velocity, feeding,
hygiene, and care practices. Outcomes were published
See Online for appendix
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in the trial protocol.28 The number of secondary
outcomes was later reduced in the online trial
registration form after feedback from the data
monitoring committee (DMC) in September, 2015.
Statistical methods
We estimated that the intervention would lead to a
0·15 dierence in length-for-age Z score at 18 months,
based on a meta-analysis of nutrition education
interventions that found a mean eect size of 0·2 (range
0·04–0·64) for length-for-age Z score at 18 months.29 We
estimated the intra-cluster correlation for stunting at
0·035 using an analysis of 42 Demographic and Health
Surveys.30 With around 25 livebirths per year in each
cluster of 1000 people and accounting for 10% attrition,
recruiting all eligible children born over 12 months in
110 clusters (2520 after attrition) would allow us to
detect a dierence of 0·15 in mean length-for-age
Z scores between intervention and control arms, with
80% power and 5% significance level.
We did analyses by intention to treat and conducted in
accordance with our DMC-approved data analysis plan.
We calculated mean dierences for continuous outcomes
and odds ratios for binary outcomes. We included
random eects for clusters in regression models. We
assessed the normality of data and variance for the
primary outcome in each study arm. Based on a two-way
scatter plot, we found no evidence that the mean or
variance of the residuals from the full model were
associated with the predicted value of the outcome, and
therefore considered linear regression appropriate. We
considered the adjusted eect measures as the main
results. On the basis of a priori opinion concerning
predictors of the primary outcome, we adjusted all child
outcomes for sex, district, multidimensional poverty
index category, residence (village or hamlet), and tribal
status (tribal or not). For anthropometry outcomes, we
planned to test dierences between arms at earlier
timepoints only if a significant dierence was seen at
18 months. For child dietary diversity and meal frequency,
we calculated summary eect measures across 12 months
and 18 months by including an additional random eect
for child and adjusting for timepoint. Following our
analysis plan, we investigated the eect of intervention
intensity by examining eect measures for intensity
subgroups relative to the control arm. However, testing
of the eect of intensity was based on analysis in the
intervention arm only. To investigate whether the
intervention eect varied by either infant sex or
multidimensional poverty index we present eect
measures by subgroup and test the interaction between
subgroup and the intervention. We did subgroup
analyses for intervention intensity and multidimensional
poverty, treating these factors as continuous or categorical
so as to detect associations that might or might not be
roughly linear.
A priori, we planned total and incremental cost and
cost-eectiveness analyses from the provider perspective
for cases of stunting averted, underweight, wasting, and
infant mortality if a significant eect was observed at
the 0·1 level. A detailed description of methods is
presented elsewhere.31 Provider costs included costs to
Figure 2: Trial profile
LAZ=length-for-age Z score.
120 clusters (units of 1000 population) randomly assigned
60 clusters assigned to control group
60 control clusters followed up
1541 infants eligible at birth
1412 found
1460 infants eligible at birth
1353 found
2967 pregnant women recruited
38 stillbirths
63 neonatal deaths
5 infants whose mothers died
9 twins or triplets
6 migrated at birth
45 stillbirths
53 neonatal deaths
2 infants whose mothers died
13 twins or triplets
3 migrated at birth
60 clusters assigned to intervention group
60 intervention clusters followed up
2814 pregnant women recruited
1495 infants eligible at 3 months
1392 found
1425 infants eligible at 3 months
1313 found
16 deaths
30 migrated
8 deaths
27 migrated
10 deaths
19 migrated
7 deaths
15 migrated
1466 infants eligible at 6 months
1358 found
1403 infants eligible at 6 months
1304 found
1439 infants eligible at 9 months
1340 found
1383 infants eligible at 9 months
1281 found
1421 infants eligible at 12 months
1320 found
1368 infants eligible at 12 months
1271 found
8 deaths
19 migrated
6 deaths
14 migrated
6 deaths
12 migrated
4 deaths
11 migrated
1415 infants eligible at 18 months
1338 found
1308 with valid LAZ (92·4% of eligible)
1362 infants eligible at 18 months
1295 found
1253 with valid LAZ (92·0% of eligible)
6 deaths 6 deaths
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the implementing agencies and to public health-care
providers. All costs were adjusted for inflation,
discounted at 3% per year and converted to 2016
international dollars (INT$).
The statistician was masked to treatment when analysing
the primary outcome for the final report presented to the
DMC. Analyses were completed unmasked. This trial is
registered as ISCRTN (51505201) and with the Clinical
Trials Registry of India (number 2014/06/004664).
Role of the funding source
Funders had no role in study design, data collection,
analysis, interpretation, or writing of the report. The
authors had full access to all data. NN and AP were
responsible for the decision to submit for publication.
Results
Between Oct 1, 2013, and Dec 31, 2015, we recruited
5781 pregnant women. 3001 infants were born to pregnant
women recruited between Oct 1, 2013, and Feb 10, 2015,
and were therefore eligible for follow-up (1460 assigned to
intervention; 1541 assigned to control; figure 2). All clusters
were retained in the study. Three groups of children could
not be included in the final analysis for length-for-age
Z score at 18 months: 147 migrated out of the study area
(67 in intervention clusters; 80 in control clusters), 77 died
after the neonatal period and before 18 months (31 in
intervention clusters; 46 in control clusters), and seven had
implausible length-for-age Z scores (<–5 SD; one in
intervention cluster; six in control clusters). We had valid
measurements for 1253 (92%) of 1362 eligible children at
18 months in intervention clusters and 1308 (92%) of 1415
in control clusters. We found no dierence in tribal or
caste status or wealth between children lost to follow-up
and those retained in the trial at 18 months overall.
Socioeconomic characteristics of mothers whose
children were eligible for follow-up were similar between
intervention and control arms (table 1). In both arms,
more than 75% of mothers were from scheduled tribe
communities, and more than 50% could not read or only
with diculty. Mothers’ mean age was also similar
between arms (intervention mean 24 years, SD 4·6;
control mean 23·9, SD 4·7). In both arms, less than
2% of households had access to a toilet.
Between Oct 1, 2013, and Aug 10, 2015, 1293 mothers
in the intervention arm were asked by data collectors if
they had attended a group meeting or received a home
visit in the past 3 months as part of their seven follow-
up interviews. In 5068 (56%) of 9051 follow-ups,
mothers said that they had attended a group meeting,
and in 7241 (80%) they said that they had received a
home visit. SPKs made an average of 37 home visits per
month, four visits to pregnant women and 33 visits to
mothers of children younger than 2 years, as compared
with our anticipated 45–50 home visits. Home visits
lasted a mean of 50 min each. Mothers received a mean
of 11 home visits (SD 5) compared with the 19 visits
planned. SPKs also supported 163 participatory groups
(2–3 each), as planned. The five most common child-
related problems prioritised by the groups were
Control Intervention All
Mothers and infants eligible at birth 1541 1460 3001
District (state)
West Singhbhum (Jharkhand) 781 (51%) 727 (50%) 1508 (50%)
Kendujhar (Odisha) 760 (49%) 733 (50%) 1493 (50%)
Residence
Main village 964 (63%) 889 (61%) 1853 (62%)
Hamlet 577 (37%) 571 (39%) 1148 (38%))
Mother’s age (years) 24·0 (4·6) 23·9 (4·7) 23·9 (4·6)
Parity 2·4 (1·6) 2·4 (1·6) 2·4 (1·6)
Class or caste status
Scheduled tribe 1199 (78%) 1100 (75%) 2299 (77%)
Scheduled caste 71 (5%) 123 (8%) 194 (7%)
Other backward class 269 (18%) 234 (16%) 503 (17%)
Other 2 (<1%) 3 (<1%) 5 (<1%)
Land ownership
Less than 2 bighas 956 (62%) 837 (57%) 1793 (60%)
Between 2 and 4 bighas 342 (22%) 355 (24%) 697 (23%)
More than 4 bighas 110 (7%) 99 (7%) 209 (7%)
Land mortgaged 6 (<1%) 7 (1%) 13 (<1%)
No land 119 (8%) 145 (10%) 264 (9%)
Missing 8 (1%) 17 (1%) 25 (1%)
Literacy
Can read easily 430 (28%) 418 (29%) 848 (28%)
Cannot read or with difficulty 907 (59%) 874 (60%) 1781 (59%)
Missing 204 (13%) 168 (11%) 372 (12%)
Education
None or less than 3 years 107 (7%) 119 (8%) 226 (8%)
Primary 171 (11%) 201 (14%) 372 (12%)
Lower secondary 283 (18%) 284 (19%) 567 (19%)
Higher secondary and above 126 (8%) 124 (9%) 250 (8%)
Missing 854 (55%) 732 (50%) 1586 (53%)
Multidimensional poverty quintiles
First (poorest) quintile 217 (14%) 221 (15%) 438 (15%)
Second quartile 319 (21%) 286 (20%) 605 (20%)
Third quartile 479 (31%) 463 (32%) 942 (31%)
Fourth quartile 428 (28%) 410 (28%) 838 (28%)
Fifth (richest) quintile 98 (6%) 80 (6%) 178 (6%)
Access to toilet
Yes—improved (flush or covered latrine) 14 (1%) 19 (1%) 33 (1%)
Yes—not improved (open latrine) 9 (<1%) 10 (1%) 19 (1%)
No toilet 1518 (99%) 1431 (98%) 2949 (98%)
Main source of drinking water
Tap 3 (<1%) 19 (1%) 22 (1%)
Hand pump or tubewell 1027 (67%) 933 (64%) 1960 (65%)
Covered dug well 24 (2%) 29 (2%) 53 (2%)
Uncovered dug well 273 (18%) 273 (19%) 546 (18%)
River, canal or spring 214 (14%) 206 (14%) 420 (14%)
Data are n (%) or mean (SD).
Table 1: Characteristics of participants
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diarrhoea, which was prioritised by 100 (61%) of
163 groups, malaria (57%), worms (47%), low
birthweight (36%), and acute respiratory infections
(32%). The five most common maternal problems
prioritised were food restrictions in pregnancy (61%),
alcohol consumption in pregnancy (53%), closely
spaced pregnancies (51%), anaemia (48%), and malaria
in pregnancy (40%). The most common strategies
addressed these problems through a combination of
home-based preventive actions, care-seeking, and
community-level activities such as planning kitchen
gardens or campaigning (eg, against early marriage).
Children’s mean length-for-age Z score at 18 months
was –2·31 (SD 1·12) in the intervention arm and –2·40
(SD 1·10) in the control arm (adjusted dierence [aD]
0·107; 95% CI –0·011 to 0·226, p=0·08; figure 3, table 2).
The intracluster correlation coecient for length-for-
age Z score at 18 months was 0·129 (95% CI
0·089–0·169). Children in intervention and control
clusters had similar mean length-for-age Z scores from
birth until 6 months, but these diverged gradually after
6 months (figure 3): the dierence in mean length-for-
age Z score (intervention – control) was –0·02 at birth,
0·03 at 3 months, 0·03 at 6 months, 0·06 at 9 months,
0·10 at 12 months, and 0·09 at 18 months (data not
shown).
We detected no eect of the intervention on mean
maternal mid-upper arm circumference in the third
trimester of pregnancy (aD 0·012; 95% CI –0·154 to 0·179,
p=0·88), or on maternal body-mass index (BMI) at
9 months post partum (aD 0·186; 95% CI –0·025 to 0·397,
p=0·08). The odds of pregnant women reporting eating
3 times or more in the past 24 h were similar between
intervention and control clusters (adjusted odds ratio
[aOR] 1·14; 95% CI 0·78 to 1·67, p=0·49), but the odds of
pregnant women reporting achieving minimum dietary
diversity in intervention clusters were increased
(aOR 1·40; 95% CI 1·03 to 1·90, p=0·0311).
Mean birthweight, weight-for-height Z score at
18 months, mid-upper arm circumference at 18 months,
and the odds of children being stunted and wasted at
18 months were similar between intervention and control
clusters. The odds of children being underweight at
18 months in intervention clusters were reduced
(aOR 0·81; 95% CI 0·66–0·99, p=0·0436).
We found no dierence between arms in the proportion
of children who were exclusively breastfed until 6 months
between intervention and control arms (intervention 51%;
control 50%; aOR 1·06; 95% CI 0·74–1·50, p=0·75), or in
the odds of children eating complementary foods by
6 months (intervention 50%; control 45%; aOR 1·30; 95%
CI 0·78–2·13, p=0.30; table 3). The odds of children
achieving minimum dietary diversity and meal frequency
at 12 months and 18 months were increased in intervention
clusters (minimum dietary diversity aOR 1·47; 95% CI
1·07–2·02, p=0·0016 and meal frequency 1·60; 1·04–2·47,
p=0·0339).
The intervention had no eect on reported morbidity,
care at home, or care-seeking for childhood illnesses: the
odds of children having diarrhoea, cough, or fever in the
past 2 weeks were similar in intervention and control
clusters (intervention 37%; control 38%; aOR 0·90;
95% CI 0·69–1·19, p=0·47; table 3), as were the odds of
receiving appropriate care for these symptoms at home
(intervention 35%; control 35%; 1·10; 0·64–1·90,
p=0·73), and the odds for care being sought from a
qualified provider (intervention 21%; control 18%;
0·87; 0·45–1·69, p=0·69). The odds of mothers reporting
washing their hands with soap before feeding children
(5·23, 2·61–10·5, p<0·0001) and after helping a child
with defecation (4·63, 2·98–7·20; p<0·0001) were
increased in intervention clusters. Infant mortality was
lower in intervention compared with control clusters
(51·4 per 1000 livebirths vs 63·8 per 1000 livebirths,
aOR 0·63, 95% CI 0·39–1·00, p=0·0496).
Increased exposure to group meetings and home
visits was associated with higher length-for-age Z scores
at 18 months, although none of the associations were
significant (table 4). We found no dierential eect of
the intervention on length-for-age Z score at 18 months
by sex (p value for interaction term 0·33), but a stronger
eect in children belonging to richer quintiles of the
multidimensional poverty index (p=0·0069; table 5).
The total annual cost of the intervention was
INT$1 413 190 (INT$1 650 296 including village health
sanitation and nutrition committee strengthening) and
the mean cost was INT$423 957 (INT$495 089 including
village health sanitation and nutrition committee
strengthening). The mean annual cost of the
intervention per livebirth was INT$290 and per
pregnant woman covered was INT$151. If one considers
beneficiaries to be all those living in the study areas, the
average annual cost of the intervention was INT$7 per
person covered. The incremental cost-eectiveness
ratios were INT$29 561 per infant death averted
Figure 3: Mean length-for-age Z scores by allocation
72 h 3 months 6 months 9 months 12 months 18 months
–2·5
Mean length-for-age Z scores
Children’s age
–2·0
–1·5 Control
Intervention
95% CI
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(INT$34 520 including village health sanitation and
nutrition committee strengthening) and INT$959 per
life-year saved (INT$1120 including village health
sanitation and nutrition committee strengthening; data
not shown, the full cost analysis will be presented in a
forthcoming publication).
Discussion
In rural eastern India, the new community-based worker
to promote interventions for growth during the first
1000 days of life, which we assessed in this trial, did not
significantly increase children’s length. The intervention
did not have an eect on maternal and child
anthropometric outcomes other than child underweight,
and did not aect morbidity or care-seeking practices.
The intervention did, however, improve self-reported
dietary diversity and handwashing, as well as infant
survival. The non-significant increments in length seen
from 6 months of age onwards could, in part, be
explained by increased dietary diversity among pregnant
women and children, and improvements in hygiene
through handwashing. Referrals for undernutrition were
not among our secondary outcomes and will be reported
in the process evaluation, but might have contributed to
increased survival: referrals to Anganwadi workers for
supplementary feeding or to malnutrition treatment
centres doubled in the intervention area, due to the
SPKs’ referrals using mid-upper arm circumference.
The size of eect on length-for-age Z score seen in this
study is in line with those reported in trials of nutrition
education without supplementary feeding, and higher
than those reported in previous trials of nutrition education
and hygiene promotion globally and in India.23 A 2013
systematic review13 of five trials found that complementary
feeding education led to a 0·23 (0·09–0·36) increase in
height-for-age Z score in children younger than 2 years. In
India, Bhandari and colleagues20 tested an intervention
emphasising appropriate infant and young child feeding,
handwashing, and adequate feeding during illness, but
found no dierence in attained length at 18 months.
Another Indian trial by Vazir and colleagues17 found no
significant dierences in length at 15 months after an
Control Intervention Adjusted effect (95% CI)* p value Unadjusted effect† p value
Primary outcome
n 1308 1253 ·· ·· ·· ··
LAZ at 18 months –2·40 (1·10) –2·31 (1·12) 0·107 (–0·011 to 0·226) 0·08‡ 0·104 (–0·034 to 0·242) 0·14
Secondary outcomes (mother)
n 2952 2805 ·· ·· ·· ··
Maternal MUAC in third trimester of
pregnancy
22·8 (1·81) 22·8 (1·89) 0·012 (–0·154 to 0·179) 0·88 0·021 (–0·167 to 0·208) 0·83
n 1240 1191 ·· ·· ·· ··
Maternal BMI at 9 months post partum 18·5 (2·13) 18·7 (2·24) 0·186 (–0·025 to 0·397) 0·08 0·190 (–0·021 to 0·402) 0·08
Secondary outcomes (child)
n 1181 1167 ·· ·· ·· ··
Birthweight 2·56 (0·40) 2·57 (0·41) 0·012 (–0·022 to 0·047) 0·48 0·011 (–0·026 to 0·047) 0·57
n 1010 1014 ·· ·· ·· ··
Change in LAZ from birth to 18 months –0·55 (1·27) –0·48 (1·25) 0·074 (–0·062 to 0·211) 0·29 0·075 (–0·064 to 0·214) 0·29
n 1279 1231 ·· ·· ·· ··
WHZ at 18 months –1·76 (1·04) –1·76 (1·04) 0·019 (–0·075 to 0·114) 0·69 0·020 (–0·083 to 0·124) 0·70
n 1283 1236 ·· ·· ·· ··
WAZ at 18 months –2·41 (1·05) –2·37 (1·05) 0·068 (–0·023 to 0·159) 0·14 0·067 (–0·042 to 0·177) 0·23
n 1311 1261 ·· ·· ·· ··
MUAC at 18 months 13·3 (0·95) 13·4 (0·95) 0·050 (–0·072 to 0·173) 0·42 0·052 (–0·082 to 0·186) 0·44
n 1308 1253 ·· ·· ·· ··
Stunting (<2 SD LAZ) at 18 months 866 (66%) 807 (64%) 0·84 (0·66 to 1·08) 0·17 0·87 (0·663 to 1·135) 0·30
n 1279 1231 ·· ·· ·· ··
Wasting (<2 SD WHZ) at 18 months 533 (42%) 487 (40%) 0·88 (0·72 to 1·07) 0·22 0·88 (0·709 to 1·083) 0·22
n 1283 1236 ·· ·· ·· ··
Underweight (<2 SD WAZ) at 18 months 839 (65%) 772 (63%) 0·81 (0·66 to 0·99) 0·04 0·82 (0·654 to 1·038) 0·10
Data are mean (SD) or n (%). BMI=body-mass index. WHZ=. WHZ=weight-for-height Z score. WAZ=weight-for-age Z score. LAZ=length-for-age Z score. MUAC=mid-upper arm circumference. *Adjusted effect
is adjusted difference except for stunting, wasting, and underweight for which the adjusted effect is adjusted overall response. Adjusted for infant sex, district, multidimensional poverty index, residence
(village or hamlet) and tribal status (all fixed effects) and cluster (random effect). All denominators include children and mothers available for follow-up and with valid anthropometric measurements using
WHO 2006 Standards plausibility criteria for LAZ, WHZ, and WAZ. †Unadjusted effect is difference except for stunting, wasting, and underweight for which the effect is overall response. Adjusted only for infant
sex, district and cluster (random effect). ‡Adjusted results with multiple imputation for missing data: adjusted difference: 0·100 (95% CI –0·028 to 0·227), p=0·13.
Table 2: Adjusted and unadjusted effects of intervention on children’s and mothers’ anthropometry
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Control Intervention Adjusted* Unadjusted†
AOR (95% CI)* p value OR (95% CI) p value
Mothers’ nutrition in pregnancy
Mothers eligible during pregnancy 2967 2814 ·· ·· ·· ··
Ate ≥3 times in last day 2412 (81%) 2359 (84%) 1·14 (0·78–1·67) 0·50 1·14 (0·77–1·67) 0·49
Minimum dietary diversity‡ 958 (32%) 1042 (37%) 1·40 (1·03–1·90) 0·0311 1·40 (1·02–1·92) 0·04
Infant and young child feeding
Infants eligible at 6 months 1368 1315 ·· ·· ·· ··
Infants exclusively breastfed until 6 months 678 (50%) 673 (51%) 1·06 (0·74–1·50) 0·75 1·08 (0·76–1·53) 0·67
Infants eligible at 9 months 1439 1383 ·· ·· ·· ··
Infants who started complementary foods at
6 months
650 (45%) 689 (50%) 1·30 (0·78–2·13) 0·30 1·28 (0·76–2·13) 0·34
Infants eligible at 12 months 1421 1368 ·· ·· ·· ··
Children with minimum dietary diversity at
12 months
394 (28%) 515 (38%) ·· ·· ·· ··
Children given minimum meal frequency at
12 months
870 (66%) 936 (74%) ·· ·· ·· ··
Infants eligible at 18 months 1415 1362 ·· ·· ·· ··
Children with minimum dietary diversity at
18 months
627 (44%) 679 (50%) ·· ·· ·· ··
Children given minimum meal frequency at
18 months
1100 (82%) 1099 (85%) ·· ·· ·· ··
Children given a source of protein§ at
18 months
620 (44%) 679 (50%) 1·30 (1·00–1·69) 0·0486 1·30 (1·00–1·69) 0·05
Combined effect measure for 12 and 18 months together
Children with minimum dietary diversity ·· ·· 1·47 (1·07–2·02) 0·0161 1·47 (1·07–2·02) 0·02
Children given minimum meal frequency ·· ·· 1·60 (1·04–2·47) 0·0339 1·59 (1·03–2·44) 0·04
Morbidity and care for sick children‡
Infants eligible at 6 months 1338 1295 ·· ·· ·· ··
Diarrhoea, cough, fever in past 2 weeks 508 (38%) 479 (37%) 0·90 (0·69–1·19) 0·47 0·92 (0·70–1·21) 0·57
Infants who experienced diarrhoea, cough, fever
in past 2 weeks
287 322 ·· ·· ·· ··
Received appropriate home care during illness
episode¶
100 (35%) 114 (35%) 1·10 (0·64–1·90) 0·73 1·10 (0·63–1·94) 0·73
Infants who experienced diarrhoea, cough, fever
in past 2 weeks
240 244 ·· ·· ·· ··
Care sought from a nurse or doctor 43 (18%) 52 (21%) 0·87 (0·45–1·69) 0·69 0·93 (0·47–1·82) 0·84
Infection control and hygiene
Infants eligible at 12 months 1421 1368 ·· ·· ·· ··
Children received BCG, OPV3, DTP3, measles,
hepatitis B vaccine
437 (31%) 441 (32%) 1·10 (0·74–1·64) 0·62 1·10 (0·72–1·67) 0·66
Infants eligible at 18 months 1298 1280 ·· ·· ·· ··
Hands washed before feeding|| 166 (13%) 438 (34%) 5·23 (2·61–10·5) <0·0001 5·03 (2·53–10·0) <0·001
Hands washed after helping with defecation|| 558 (43%) 919 (72%) 4·63 (2·98–7·20) <0·0001 4·45 (2·88–6·86) <0·001
Hands washed after defecation|| 579 (45%) 922 (72%) 4·40 (2·87–6·73) <0·0001 4·18 (2·75–6·38) <0·001
Mortality
Infant deaths/livebirths (infant mortality per
1000 live births)
103/1613 (63·8) 78/1516 (51·4) 0·63 (0·39–1·00) 0·0496 0·60 (0·35–1·01) 0·06
Data are n (%) or mean (SD) unless otherwise specified. All secondary outcomes are self-reported. Deaths were verified by verbal autopsy. All denominators are eligible
participants at each follow-up with data for the outcomes presented. DTP3=3 doses of diphtheria-tetanus-pertussis vaccine. OR=overall response. aOR=adjusted overall
response. OPV3=3 doses of oral polio vaccine.*Adjusted for infant sex, district, multidimensional poverty index, tribal status (all fixed effects), residence (village or hamlet)
and village (random effect). †Adjusted for district (fixed effects) and village (random effect) only. ‡Defined as receiving foods from four or more food groups. §Includes
animal or non-animal protein (eg, egg, soya bean chunks, or powdered grain with soya). ¶Fluid replacement through oral rehydration therapy for diarrhoea and continued
feeding during illness. ||Hands washed by mothers.
Table 3: Adjusted and unadjusted odds ratios for intervention effects on other secondary outcomes
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intervention to promote complementary and responsive
feeding. These small or null eects on growth also echo
results from the Alive & Thrive programme in Bangladesh,
in which intensive infant and young child feeding
counselling through home visits, community mobilisation,
and mass media campaigns led to significant
improvements in exclusive breastfeeding, timely initiation
of complementary feeding, and consumption of protein,
but no significant change in length-for-age Z score.21 The
evidence available to date therefore confirms that
community interventions to improve infant and young
child feeding and hygiene through handwashing, care-
giving and care-seeking during illness, though necessary,
will only lead to small changes in length-for-age Z score.
This further underscores the importance of investing
in girls and women’s nutrition and going beyond
immediate determinants to achieve substantial
reductions in stunting. A 2016 analysis found that the
leading risk factor for stunting among children younger
than 2 years worldwide and in south Asia is being born
small for gestational age (10·8 million out of 44·1 million
cases), followed by poor sanitation (7·2 million cases)
and diarrhoea (5·8 million cases).32 Dietary insuciency
in pregnancy, and groups’ limited ability to influence the
provision of clean water, sanitation, and key services in
their villages could partly explain our small eect on
length-for-age Z score.33 Ongoing trials are exploring the
eects of combining nutrition-sensitive agriculture
interventions and water, sanitation, and hygiene (WASH)
interventions with nutrition-related behaviour change.34,35
Even with considerable investment in health, nutrition,
and WASH interventions, however, the reduction of
stunting is perhaps best contemplated on a multi-
generational horizon. In an analysis36 of longitudinal
growth data from three Gambian villages where
free primary and antenatal care, comprehensive
immunisation, improved water and sanitation, and
treatment for malnutrition were available, the prevalence
of stunting among 2-year-olds halved between 1972 and
2012, but remained high at 30%. Countries with equity-
oriented public policies, including income redistribution,
universal access to education, health, water supply, and
sanitation services, have achieved rapid and substantial
declines in stunting, confirming the need for action on
underlying and basic determinants of undernutrition.37
Our study had important strengths. We had a
high follow-up rate and minimised technical error of
measurement by carrying out three three standardisation
exercises. Additionally, we traced children’s growth at
six timepoints, and the incremental gains in growth seen
in the intervention arm compared with the control arm
over time support our belief that this is a genuine eect.
Our study also had limitations. First, several of our
secondary outcomes, including dietary diversity and
handwashing with soap, were measured using self-
reported data. These data could be aected by social
desirability bias, which might have led to over-reporting
of desirable practices. However, the dierences in
practices between the two arms were not consistent for
all self-reported outcomes, which suggests that bias is
unlikely. Second, although both home visits and group
meetings promoted age-appropriate stimulation for
young children, we were unable to measure the eect of
this on children’s development due to diculties in
obtaining a validated and acceptable assessment tool for
our multilingual, rural context. Finally, although the
associations detected in our subgroup analyses are
n (%) LAZ, mean
(SD)
Difference (95% CI)* Intensity p value
Exposure to women’s groups across all follow-ups†
Control arm 1414 (51%) –2·40 (1·10) 0 0·42 (categorical);
0·22 (linear)
None 196 (7%) –2·31 (1·02) 0·058 (–0·123 to 0·240) ··
Attended <10 meetings 941 (34%) –2·35 (1·14) 0·102 (–0·022 to 0·225) ··
Attended ≥10 meetings 219 (8%) –2·17 (1·12) 0·173 (–0·002 to 0·348) ··
Exposure to home visits across all follow-ups†
Control arm 1414 (51%) –2·40 (1·11) 0 0·56 (categorical);
0·21 (linear)
Received <10 home visits 480 (17%) –2·48 (1·09) 0·076 (–0·070 to 0·221) ··
Received ≥10 home visits 876 (32%) –2·23 (1·13) 0·124 (–0·003 to 0·251) ··
Exposure to group meetings and home visits across all follow-ups†
Control arm 1414 (51%) –2·40 (1·11) 0 0·68 (categorical)
No meeting attended
and <10 home visits
109 (4%) –2·37 (1·03) 0·120 (–0·106 to 0·346) ··
Intermediate 1038 (38%) –2·34 (1·13) 0·095 (–0·028 to 0·217) ··
≥10 group meetings and
≥10 home visits
209 (8%) –2·17 (1·13) 0·164 (–0·014 to 0·342) ··
Subgroup analyses. MPI= multidimensional poverty index. LAZ=length-for-age Z score. *Analyses adjusted for district,
belonging to a scheduled tribe and scheduled caste, child sex, MPI, and whether hamlet or village residence (fixed
effects) and for village (random effect). †All exposures are self-reported.
Table 4: Effect on LAZ at 18 months by intensity of intervention exposure
Control Intervention Difference (95% CI)* Interaction
p value
n Mean LAZ
(SD)
n Mean LAZ
(SD)
Infant sex
Female 732 –2·04 (1·10) 664 –1·90 (1·09) 0·145 (0·005 to 0·285) 0·33
Male 682 –2·78 (0·97) 692 –2·70 (1·01) 0·065 (–0·075 to 0·204) ··
Multidimensional poverty index quintiles
First (poorest) 190 –2·77 (1·07) 197 –2·74 (1·08) –0·033 (–0·255 to 0·189) 0·082
(categorical);
0·0069
(linear)
Second 292 –2·59 (1·03) 260 –2·53 (1·13) 0·020 (–0·190 to 0·229) ··
Third 440 –2·34 (1·14) 436 –2·27 (1·03) 0·145 (–0·026 to 0·315) ··
Fourth 398 –2·25 (1·09) 390 –2·12 (1·12) 0·207 (0·023 to 0·391) ··
Fifth (richest) 94 –1·96 (1·04) 73 –1·68 (1·18) 0·311 (–0·013 to 0·636) ··
LAZ=length-for-age Z score. *Analyses adjusted for district, belonging to a scheduled tribe and scheduled caste,
and whether hamlet or village residence (fixed effects) and for village (random effect).
Table 5: Intervention effect on LAZ at 18 months by infant sex and multidimensional poverty index quartiles
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plausible, results should be interpreted with caution
considering the number of tests performed.
The cost-eectiveness ratios of INT$959–1120 per life-
year saved is well below India’s gross domestic product
(GDP) per capita of INT$6089 (in 2015). This indicates
that the intervention is highly cost-eective in reducing
infant deaths in this context, according to WHO criteria.38
Should a second worker be introduced in 200 Indian
districts with a high burden of undernutrition? Our trial
suggests this is feasible and could aect dietary diversity,
handwashing, and infant survival, but a substantial
eect would not be expected on maternal or child anthro-
pometry in the short term. Let us consider alternative
options to expand the coverage of nutrition-specific
interventions for pregnant women and children younger
than 2 years in rural areas. First, the working hours and
honorarium of the existing Anganwadi worker could be
increased to enable her to reach more pregnant women
and children. This solution has proved unpopular with
decisionmakers in the past because of concerns about the
financial consequences of increasing honoraria for more
than 14 million workers. Self-help groups are a promising
platform through which to deliver health, hygiene, and
nutrition interventions; however, they require trained
facilitators, links to the health system, and no rigorous
evidence currently exists about the eects of working with
such groups on health and nutrition in the first 1000 days
of life. The Mother’s Absolute Aection programme, which
was launched last year, mandates the training and
incentivisation of accredited social health activists to
promote infant and young child feeding in the first 2 years
of life through home visits and group meetings, along with
screening and referral for acute malnutrition with mid-
upper arm circumference, activities very similar to those
tested in this trial.39 The National Health Mission has also
sanctioned the scale-up and incentivisation of accredited
social health activists to conduct participatory learning and
action meetings to improve maternal and child health
across ten states. Future research might therefore explore
how to optimise the home visiting and participatory
women’s groups materials created during this trial and
other studies for accredited social health activists, so that
the number and content of home visits aligns with those
recommended in WHO’s Caring for the Childs Healthy
Growth and Development, and women’s groups have an
opportunity to discuss how to address the immediate and
underlying determinants of child undernutrition in a
voluntary, participatory, and context-appropriate manner.40
Such action will be necessary but not sucient to achieve
the ambitious goal of reducing stunting by 40% by 2025.
This goal will require sustained, equity-focused investment
in nutrition-sensitive inter ventions including clean water,
sanitation, family planning, girls’ education, and social
safety nets.
Contributors
NN, PT, HSS, SB, NS, ACos, ACop, RS, JS-W, and AP conceptualised the
study. ACop and AP developed the data analysis plan and conducted the
analyses with HP. NN, HP, RG, SG, ShR, SuR, VS, and SSR led the
training of the intervention and data collection teams, and supervised all
study activities. SS and SSR designed and tested data collection tools for
mobile phones with Dimagi India. SuR led the trial process evaluation
with SB and AS. JS-W, RS, and HH-B led the economic evaluation.
Declaration of interests
We declare no competing interests.
Acknowledgments
We thank the mothers and children who took part in the study, as well as
the SPKs, Auxillary Nurse Midwives, accredited social health activists,
and anganwadis in participating clusters. We thank Jagannath Hembrom
(Malnutrition Treatment Centre, West Singhbhum, India), who provided
support for referrals for severely acutely malnourished children. We
thank Sanjay Kinra (Chair; London School of Hygiene and Tropical
Medicine, London, UK), Charlotte Wright (University of Glasgow,
Glasgow, UK), and Anne Philpott (Department for International
Development [DfID], London UK) for their guidance as members of the
trial steering committee. We thank Umesh Kapil (All India Institute of
Medical Sciences [AIIMS], New Delhi, India), Purnima Menon
(International Food Policy Research Institute, Washington, DC, USA),
and Anuraag Chaturvedi (Public Health Foundation of India, Haryana,
India) for being members of the trial advisory group. We thank
Alan Dangour (Chair; London School of Hygiene and Tropical Medicine),
Piyush Gupta (University College of Medical Sciences, Delhi, India), and
Katherine Fielding (London School of Hygiene and Tropical Medicine)
for being members of the trial data monitoring committee. We thank
David Osrin (University College London, London, UK) for comments on
the manuscript. We dedicate this study to Panna Choudhury, the former
National President of the Indian Academy of Pediatrics and our first
DMC Chair, who died in 2015.
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