| CTRI Number |
CTRI/2016/11/007482 [Registered on: 24/11/2016] Trial Registered Prospectively |
| Last Modified On: |
24/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Integrated multisectoral strategy to improve girls’ and women’s nutrition before conception, during pregnancy and after birth in India (Swabhimaan) |
Scientific Title of Study
Modification(s)
|
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
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| RIDIE-STUDY-ID-58261b2f46876 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vani Sethi |
| Address |
73 Lodhi Estate
New Delhi
DELHI
110003
India |
| Phone |
|
| Fax |
|
| Email |
vsethi@unicef.org |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sayeed Unisa |
| Address |
Govandi Station Road, Deonar
Mumbai
MAHARASHTRA
400088
India |
| Phone |
|
| Fax |
|
| Email |
unisa@iips.net |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Vani Sethi |
| Address |
73 Lodhi Estate
New Delhi
DELHI
110003
India |
| Phone |
|
| Fax |
|
| Email |
vsethi@unicef.org |
|
|
Source of Monetary or Material Support
|
| UNICEF India and
State Rural Livelihood Missions (Bihar, Chhattisgarh and Odisha) |
|
|
Primary Sponsor
|
| Name |
UNICEF India |
| Address |
Child Development and Nutrition Section,
UNICEF India
73 Lodhi Estate, New Delhi-110003, India
|
| Type of Sponsor |
Other [UN agency] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| State Rural Livelihood Mission |
Bihar (Patna)
Chattisgarh (Raipur)
Odisha (Bhubaneswar) |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manisha Ruikar |
Bastar block (Dr. Manisha Ruikar) |
Bastar Block Development Office
Chattisgarh Livelihood Mission (BiHAAN)
Bastar
|
8518881909
manisharuikar@rediffmail.com |
| Neeraj Agarwal |
Kasba and Jalalgarh (Dr. Neeraj Agarwal) |
Kasba block Development oFfice
Jeevika Livelihood Mission
Purnia
|
9771913197
neeraj502@rediffmail.com |
| Vikas Bhatia |
Koraput block (Dr. Vikas Bhatia) |
Block Development Officer, Odisha Livelihood Mission
Koraput
|
9438884000
bhatiaaiims@gmail.com |
| Vikas Bhatia |
Pallara blocks (Dr. Vikas Bhatia) |
Block Development Officer
Odisha Livelihood Mission
Anugul
|
9438884000
bhatiaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar (For Koraput Block, Koraput district, Odisha) |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar (For Pallara block, Anugul district, Odisha) |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Patna (For Kasba and Jalalgarh block, Purnia district, Bihar) |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Raipur (For Bastar Block, Bastar district, Chattisgarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nutritional status of adolescent girls, pregnant women and mothers of children under age of two years |
|
Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Community-based interventions plus system strengthening interventions (3 years) |
Systems strengthening interventions include training of service providers and improving monitoring activities to improve the coverage and quality of food security entitlements programmes as well as health, nutrition, water and sanitation services.
Community-based interventions include the community demand generation and facilitation of federated women’s self-help groups, adolescent groups, and farmer’s groups to improve knowledge, service demand and household practices and farm-based practices relevant to improving nutrition of girls and women (3 years) |
| Comparator Agent |
System strengthening interventions only |
Systems strengthening interventions include training of service providers and improving monitoring activities to improve the coverage and quality of food security entitlements programmes as well as health, nutrition, water and sanitation services. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
all girls 10-19 years, pregnant women and mothers of under-two children residing in the intervention and control arms |
|
| ExclusionCriteria |
| Details |
Girls and women with severe auditory impairments as well as those with severe mental health illness. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) proportion of adolescent girls with BMI 18.5 kg/m2
(2)mean MUAC among pregnant women
(3) proportion of mothers of children under two with BMI18.5 kg/m2
|
Primary outcome (baseline 2016 - endline 2020)Primary outcome (baseline 2016 - endline 2020)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 18 secondary outcome indicators |
2016
2020 |
|
|
Target Sample Size
|
Total Sample Size="185974"
Sample Size from India="185974" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/01/2017 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
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Brief Summary
|
| UNICEF India is assisting the three States’ Livelihood Missions (JEEViKA) to implement the integrated strategy( Swabhimaan) in collaboration with the Integrated Child Development Services (ICDS), the National Health Mission (NHM), the Department of Health and Family Welfare, the Department of Social Welfare; Civil Supplies, Agriculture, Public Health and Engineering and non-government partners Ekjut and Living Farms; and Food and Agriculture Organization of United Nations and Wet Hunger Hilfe as additional partners to support Agriculture interventions in Bihar |
The evaluation is being guided by a technical advisory group and led by the All India Institute of Medical Sciences (AIIMS) Bihar, Chhattisgarh, Odisha with technical support from International Institute of Population Sciences (as lead agency) and University College London (technical agency).
The integrated strategy (Swabhimaan) aims to improve girls’ and women’s nutrition before conception, during pregnancy, and after birth, in rural areas of three States in India. Its objectives are t (1)Improve the food and nutrient intake of girls and women (2)Prevent micronutrient deficiencies and nutritional anaemia (3)Increase access to services during Village Health Nutrition and Sanitation Days and provide special care to nutritionally ‘at risk’ women (4)Increase access to education about water and sanitation and access to WASH commodities (5)Prevent early, poorly spaced and repeated pregnancies (6)The strategy’s main beneficiaries are adolescent girls, newlywed women, pregnant women and mothers of children under two. The strategy involves both systems strengthening and community-based activities. Systems strengthening activities will be carried out in both intervention and control arms and include: 1.Strengthening Village Health, Sanitation and Nutrition Days (VHSND) to improve access to antenatal care, family planning and micronutrient supplementation. Strengthening will involve quarterly trainings of health service providers, monthly review of nutrition indicators and the identification women at risk of undernutrition (MUAC <23cm) for special supplementary food and counselling 2.Strengthening adolescent health day to improve access to adolescent health, nutrition services via quarterly trainings of health service providers 3.An extended Village Health, Sanitation and Nutrition Day once every six months for newly-wed and women, including individual counselling and information about entitlement camps 4.Annual Training and follow-up meetings with service providers from food security, Integrated Child Development Services, water and sanitation departments to help them improve the delivery of entitlements and services 5.Regularizing block nutrition convergence review mechanism Community-based activities will be carried out in intervention areas only, and include: 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 All the target groups (adolescent girls 10-19 years, pregnant women and mothers of under-two years) in both the intervention and control arms will receive the system strengthening interventions. These target groups only in intervention arm will receive the community-level interventions. Across five blocks in three states, an estimated 104198 adolescent girls, 27508 pregnant woman and - 54268 mothers of under-two years will received the intervention. The Swabhimaan programme evaluation therefore tests the added value of community-level activities in comparison to systems-level activities alone. Villages in intervention and control arms will be selected to take part in baseline and endline surveys. In Bihar, a full household listing was conducted to identify adolescent girls aged 10-19 years, pregnant women and mothers of children under two in all programme areas. Simple random sampling was then used to select respondents in each of these three groups. In Chhattisgarh, 224 villages in two blocks (administrative areas of around 100,000 population) were paired on the basis of population size and whether they had held a monthly Village Health and Nutrition Day for the last three months. Forty such pairs (a total of 80 villages) were then randomly selected for data collection, and all eligible respondents in each of the three target groups in these 80 villages were approached for interview. In Odisha, a set of 12 Gram Panchayats (administrative units of around 5000 population in two blocks have been purposively identified as the intervention areas, and all remaining Gram Panchayats in the two blocks serve as control areas. All eligible respondents in each of the three target groups will be approached for interview. 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. |
Analysis will be by intention-to-treat and carried out at an individual level, adjusting for clustering at the level of the village and Village Organisation using linear and logistic random effects models in STATA 14. In each State, we will assess the comparability of intervention and control arms at baseline by examining area-level and individual level characteristics, including: the number of self-help groups and village organisations in each area, the socio-demographic profile of respondents and their households (caste, literacy and assets) and key evaluation outcomes at baseline. We will use the difference-in-difference method to compare primary and secondary outcomes between intervention and control at endline, adjusting for their baseline values and for other characteristics that differed significantly between the two arms at baseline. We will present analyses both a State level, and conducted a pooled analysis with data from all States.
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