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 effect 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 difference
0·107, 95% CI −0·011 to 0·226, p=0·08). The intervention did not significantly affect
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).