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Study Overview

Title:
Integrated multisectoral strategy to improve girls’ and women’s nutrition before conception, during pregnancy and after birth in India (Swabhimaan): prospective, non-randomised controlled evaluation
Study ID:
RIDIE-STUDY-ID-58261b2f46876
Initial Registration Date:
11/11/2016
Last Update Date:
10/29/2016
Study Status:
Ongoing
Location(s):
India
Abstract:
Our objective is to evaluate community-based activities to improve girls’ and women’s nutrition before conception, during pregnancy and after birth in rural areas of three Indian states: Bihar, Chhattisgarh and Odisha. Community-based activities include the facilitation of federated women’s self-help groups, adolescent groups and farmer’s groups to improve knowledge and practices relevant to maternal nutrition. Both intervention and control areas will also receive systems strengthening activities to improve the coverage of food security entitlements, health, nutrition, water and sanitation services. The study is a prospective, non-randomised controlled evaluation in which, within across three States, five areas will be purposively allocated to starting community-level activities in 2016, and five other areas will be allocated to starting 36 months later, in 2019. The evaluation’s three primary outcomes are: (1) the proportion of adolescent girls with BMI <18.5 kg/m2; (2) mean Mid-Upper Arm Circumference (MUAC) among pregnant women; and (3) the proportion of mothers of children under two with BMI<18.5 kg/m2.
Categories:
Agriculture and Rural Development
Health, Nutrition, and Population
Multisector
Water and Sanitation
Additional Keywords:
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Dr Vani Sethi
Affiliation:
UNICEF India
Name of Second PI:
Prof Sayeed Unisa
Affiliation:
International Institute of Population Sciences, Mumbai

Study Sponsor

Name:
UNICEF India
Study Sponsor Location:
India
Funding Proposal:

Research Partner

Name of Partner Institution:
All India Institute of Medical Sciences in Bihar, Chhattisgarh and Odisha; IIPS Mumbai; University College London (UK)
Type of Organization:
Research institute/University
Website:
Location:
India
Intervention

Intervention Overview

Intervention:
Treatment arm: A package of community-based activities, including: 1. Women’s self-help groups federated as Village Organisations (VO) will implement integrated village health, nutrition and Water and Sanitation Hygiene (WASH) plans through cash grants received by the State Rural Livelihood Missions via the Vulnerability Reduction Fund 2. Trained community cadres facilitating meetings with women’s self-help groups every month using participatory learning and action cycle 3. Trained cadres forming and facilitating weekly adolescent girls’ clubs for discussions using a participatory learning and action cycle 4. Quarterly trainings in nutrition-sensitive agriculture for farmer’s groups, creation of community nutrition-sensitive agriculture demonstration sites, and promotion of micronutrient-rich kitchen gardens 5. Fortnightly meetings for women with MUAC <23cm, with provision of seed grants for agriculture and poultry-rearing activities 6. Biannual meetings and rallies for newly-wed couples Control arm: In the control arm, villages will receive all systems strengthening activities but none of the community-level activities.
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
UNICEF India and the three States’ Livelihood Missions (JEEViKA) in collaboration with Integrated Child Development Services (ICDS) and NHM
Type of Organization:
Foreign or Multilateral Aid Agency

Program Funder

Name of Organization:
UNICEF India
Type of Organization:
Foreign or Multilateral Aid Agency

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
01/02/2017
End Date:
12/30/2019
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Other (specify)
Other (not Listed) Method:
Prospective, non-randomised controlled evaluation
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
The study is a prospective non-randomised controlled evaluation. Five areas (two in Bihar, one in Chhattisgarh, and two in Odisha) will be purposively allocated to receiving the integrated intervention in 2017. Villages in intervention and control areas will be purposively selected to take part in baseline and endline surveys. Areas will be selected if they have had village organizations under the National Rural Livelihood Mission for at least two years. See supplementary files for details of sampling methods. Data collection teams and analysts will be blind to allocation. Analysis will be by intention-to-treat and carried out at an individual level, adjusting for clustering using linear and logistic random effects models in STATA 14. In each state, we will assess the comparability of intervention and control areas at baseline. We will use the difference-in-difference method to compare primary and secondary outcomes between intervention and control at endline, adjusting for baseline differences. We will present analyses both a State level, and conducted a pooled analysis with data from all States.
Outcomes (Endpoints):
Primary outcomes: 1. % adolescent girls (aged 10-19) with BMI <18.5 kg/m2 2. mean MUAC among pregnant women 3. % mothers of children under two with <18.5 kg/m2 Please see supplementary file for a full list of secondary outcomes.
Measurement:
Unit of Analysis:
Individual
Hypotheses:
1. We hypothesise that the Swabhimaan programme will lead to a 15% reduction in the proportion of adolescent girls with a BMI<18.5, a 15% reduction in the proportion of mothers of children under two with a BMI<18.5, and a 0.4cm improvement in mean MUAC among pregnant women, over the intervention period of three years. 2. We hypothesize that the Swabhimaan programme will lead to improvements of between 5% and 20% in the coverage of 18 key nutrition specific and sensitive interventions over three years.
Unit of Intervention or Assignment:
The unit of assignment is an area comprising a defined number of villages (see supplementary file for more details).
Number of Clusters in Sample:
Ten areas across all three States (five intervention and five control)
Number of Individuals in Sample:
We estimate that baseline and endline surveys will include a total of 6638 adolescent girls, 19,790 mothers of children under two and 2992 pregnant women across the three States.
Size of Treatment, Control, or Comparison Subsamples:
In the control areas, we anticipating conducting surveys with: 3319 adolescent girls; 9895 mothers of children under two; 1496 pregnant women (half of all total survey participants)

Supplementary Files

Analysis Plan:
Swabhimaan_RIDIE_registration_Supplementary_file_12October2016.docx
Other Documents:
Data

Outcomes Data

Description:
Four datasets will be generated per State, per survey: (1) a household census dataset; (2) a dataset with information from adolescent girls; (3) a dataset with information from pregnant women and (4) a dataset with information from mothers of children under two.
Data Already Collected?
No
Survey Name:
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
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Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

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Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
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Unit of Analysis:
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Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
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Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

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