Community intervention to improve growth among children under two in rural India

ISRCTN	ISRCTN51505201
DOI	https://doi.org/10.1186/ISRCTN51505201
Protocol serial number	N/A
Sponsor	University College London (UK)
Funders	Wellcome Trust, Department for International Development, Medical Research Council

Submission date: 09/12/2013
Registration date: 13/12/2013
Last edited: 11/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The Government of India's Integrated Child Development Services programme has recommended the introduction of a new community-based worker focused intervention on improving the health and nutrition of mothers in pregnancy and children under two in rural, underserved areas of India, where 40% of the world's undernourished children live today. In this study, we will test a community intervention in rural eastern India in order to understand whether, how and at what cost the intervention can improve children's growth.

Who can participate?
The study aims to recruit 120 geographical clusters composed of villages and adjoining hamlets located in rural areas of Jharkhand and Odisha (eastern India). Within those clusters, the study aims to recruit 2520 pregnant women and their children.

What does the study involve?
The 120 clusters recruited to participate in the study will be randomly allocated to the community intervention group or to the control group. In the intervention group, in each cluster, a trained community worker will lead monthly counseling sessions through home visits to all mothers of children under two, and participatory meetings with women's groups. Home visits and group meetings will aim to promote nutrition and health in pregnancy and the first two years of life. Both intervention and control clusters will receive an intervention aimed at building the capacity of Village Health Sanitation and Nutrition Committees. In intervention and control clusters, every pregnant woman recruited to the study will be interviewed in the third trimester of pregnancy, and then in the first, third, sixth, ninth, twelfth and eighteenth month of her child's life, in order to monitor how the child is growing, what is the childeating, and whether the child has fallen ill. At the end of the study, we will compare length, weight, feeding practices and illnesses among children born in intervention clusters and those in control clusters.

What are the possible benefits and risks of participating?
There are three main benefits of taking part: children identified as severely acutely malnourished by the trial team will be referred for care in both intervention and control areas; the intervention may lead to greater responsiveness of local health and nutrition services; and both intervention and control clusters will receive an intervention to strengthen the capacity of Village Health Sanitation and Nutrition Committees. If the intervention is found to improve children's growth, there may be further benefit to control clusters and similar areas if the study influences further support for a community-based worker devoted to health and nutrition in rural India. There are no known risks of participating for pregnant women and children.

Where is the study run from?
In India, the study is run by the civil society organization Ekjut (http://www.ekjutindia.org) and the Public Health Foundation of India (http://www.phfi.org). In the UK, the study is supported by University College London's Institute for Global Health (http://www.ucl.ac.uk/igh). The study is village-based. Potential respondents will be visited at home and invited to participate.

When is the study starting and how long is it expected to run for?
The study started in April 2013 and is expected to run until January 2017. Recruitment of clusters began in June 2013, and recruitment of pregnant women began in October 2013. Data collection is expected to take place between October 2013 and August 2016.

Who is funding the study?
The study is funded by the Wellcome Trust, the UK Medical Research Council, and the Department for International Development (DFID) through their joint Global Health Trial scheme.

Who is the main contact?
Dr Nirmala Nair, nirmala.ekjut@gmail.com
Dr Audrey Prost, Audrey.prost@ucl.ac.uk

Contact information

Dr Audrey Prost
Scientific

UCL Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2839
Email	audrey.prost@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial, parallel design
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Cluster-randomised controlled trial of a community intervention to improve growth among children under two in rural India
Study acronym	CARING (Community Action Research for Improved Nutrition and Growth in rural India)
Study objectives	We hypothesize that an intervention involving a community-based worker carrying out monthly participatory meetings with local women's groups and home visits to all mothers of children under two in her village with the goal of promoting appropriate nutrition along with preventive and treatment health behaviours in pregnancy and the first two years of life, will improve the growth of children under two in rural India.
Ethics approval(s)	1. The Institutional Ethics Committee of the Public Health Foundation of India, 10/06/2013, ref: TRC-IEC-163/13 2. University College London's Research Ethics Committee, 11/06/2013, ref: 1881/002 3. Ekjut Independent Ethics Committee, 10/05/2013
Health condition(s) or problem(s) studied	Improving growth and nutrition in children
Intervention	The intervention to be tested involves a community worker carrying out two activities: (a) monthly home visits to all children aged 0-24 months and their mothers in order to support appropriate feeding, infection control and caregiving; (b) a monthly participatory women's group meeting to catalyse individual and community action for maternal and child health and nutrition. In addition, both intervention and control clusters will receive an intervention aimed at building the capacity of Village Health Sanitation and Nutrition Committees (VHSNCs) through group meetings with Committee members. In these meetings, VHSNCs will be offered information assistance with planning and monitoring their activities.
Intervention type	Other
Primary outcome measure(s)	Children's length-for-age mean Z scores at 18 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 26/07/2016: 1. Mean weight for height z score at 18 months 2. Mean weight for age z score at 18 months 3. Mean MUAC z score at 18 months 4. % of children who are stunted at 18 months 5. % of children who are underweight at 18 months 6. % of children who are wasted at 18 months 7. Mean birth weight (within 72h) 8. Change in weight from birth to 18 months 9. Change in height from birth to 18 months 10. Mean length for age z score at 72h, 3, 6, 9 and 12 months 11. Mean weight for height z score at 72h, 3, 6, 9 and 12 months 12. Mean weight for age z score at 72h, 3, 6, 9 and 12 months 13. Mean MUAC z score at 6, 9 and 12 months 14. Mean maternal MUAC in third trimester of pregnancy 15. Mean maternal BMI 9 months after delivery 16. Mean number of meals per day in pregnancy 17. % pregnant women with minimum dietary diversity 18. % infants exclusively breastfed until 6 months 19. % infants who started complementary foods at six months 20. % children given food from 4 or more groups at 9, 12 and 18 months 21. % children given minimum meal frequency at 6,9, 12 and 18 months 22. % children given iron-rich foods at 6, 9, 12 and 18 months 23. % children given a source of protein at 6, 9, 12 and 18 months 24. % children with diarrhoea, cough, fever in past 2 weeks 25. % children receiving appropriate care during illness episode (fluid replacement for diarrhoea and continued feeding for all illnesses) 26. % sick children for whom care was sought from appropriate provider 27. % children who received appropriate treatment from qualified provider 28. % children who received BCG, OPV3, DTP3, measles and Hepatitis B 29. Mean score in handwashing index 30. Infant mortality rate (per 1000 livebirths) Previous secondary outcome measures: 1. Mean Z scores for weight-for-age and weight-for-height through anthropometry at birth, 3, 6, 9, 12 and 18 months 2. Prevalence of stunting, underweight, and wasting 3. Mean MUAC in third trimester of pregnancy 4. Birthweight 5. Growth velocity between 0 and 18 months 6. Infant mortality rate 7. 24 hour dietary recall and dietary diversity scores for mothers in the third trimester of pregnancy and at 3 and 6 months post-delivery 8. Birth spacing 9. Exclusive breastfeeding 10. Dietary recall and dietary diversity scores at 6, 9, 12 and 18 months 11. Hygienic practices in childcare and preparation of food 12. Uptake of preventive and care-seeking interventions for infections including: handwashing, Vitamin A supplementation, immunisation, use of oral rehydration solution 13. Care-seeking for childhood illnesses 14. Maternal BMI 9 months after delivery 15. Maternal empowerment 16. Maternal psychosocial distress 17. Community worker knowledge of infant and young child feeding (post-training)
Completion date	01/01/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	All
Target sample size at registration	2520
Key inclusion criteria	1. All women identified in the third trimester of pregnancy between 01/10/2013 and 31/12/2015 residing in the study clusters will be invited to participate in the study in order to monitor changes in food intake and dietary diversity among pregnant women. 2. In addition, every woman identified as pregnant between 01/10/2013 and 31/08/2014 residing in the study clusters will be asked for permission to follow-up her live born child for a period of 18 months. Mothers and their children will be followed up at seven time points: in the third trimester of pregnancy, within 72 hours after birth, and at 3, 6, 9, 12 and 18 months after birth.
Key exclusion criteria	1. Stillbirths and neonatal deaths 2. Infants whose mothers have died 3. Infants with congenital abnormalities and multiple births 4. Mothers who migrate out of the study area permanently during the study period
Date of first enrolment	01/06/2013
Date of final enrolment	30/06/2016

Locations

Countries of recruitment

United Kingdom
England
India

Study participating centre

UCL Institute for Global Health

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	15/04/2015		Yes	No
Protocol article	economic evaluation protocol	02/11/2016	11/02/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/02/2021: Publication reference added.
23/02/2015: the overall trial end date was changed from 30/06/2016 to 01/01/2017.