- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443997
Systems Strengthening Interventions to Improve Quality and Co-coverage of Nutrition Services in Gujarat, India
To What Extent do Systems Strengthening Interventions and Engagement With Local Governance Improve the Quality and Co-coverage of Nutrition Services in Gujarat, India? A Cluster-randomized Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study uses a cluster-randomized design with cross-sectional baseline and endline surveys to generate a proof-of-concept around an implementation model that aims to strengthen systems for delivery of individual interventions and to strengthen convergence of multiple interventions on the same households/families. The primary objectives of the study are to answer the following questions:
- To what extent and through which pathways can overall system strengthening approaches improve quality of delivery of health and ICDS services?
- To what extent and through which pathways do system strengthening approaches and focused local efforts to engage multiple sectors improve coverage of individual interventions and co-coverage of multiple interventions in the first 1,000-days?
- Can efforts to improve the nutritional value and palatability of take-home rations within the ICDS increase acceptability and use?
This study will also measure a range of secondary outcomes, for each research question as well as outcomes that pertain to the pathways of impact of the five intervention components. These include
- MIYCN capacity building
- Strengthening Supportive Supervision (SS) of the ICDS & Health Supervisory Cadre
- Strategic Use of Data (SUD) & Convergent Action Plan
- Involving Panchayati Raj Members (PRIs) for improved Co-Coverage of nutrition services
- THR offering refinement
Prior to the baseline survey, 13 out of 26 blocks from three districts randomly allocated to receive interventions. Another 13 blocks from the same three districts were randomly allocated to the comparison groups which received standard government services. The selection of three districts was based on the discussion between A&T team and the Government of Gujarat. A team comprising of representatives from A&T, IFPRI and local government worked closely to ensure matching and comparability between the intervention and comparison blocks using a propensity score matching method prior to randomization to intervention or comparison groups.
At baseline, information related to primary and secondary outcomes will be collected, along with indicators along the pathway from program inputs to outcomes. Insights on implementation will be documented throughout the evaluation period through routine meetings with the implementation teams, field visits by the research team, review of monitoring data collected by the implementation team, and backend data from the supervisory and PRI apps. Endline will be collected after approximately one year from baseline and will use mixed methods approach wherein surveys will be conducted at the sector, village, and household levels and semi-structured interviews will be conducted with the block and district staff. In addition, observations will be conducted of interactions between supervisors and FLWs at the village level. Finally, an assessment of child growth outcomes will be conducted after exploring the availability and data quality of longitudinal data being gathered at AWCs by IIPH-G, contingent on data access and approval from the state government.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phuong H Nguyen, PhD
- Phone Number: 2028264088
- Email: P.H.Nguyen@cgiar.org
Study Contact Backup
- Name: Rasmi Avula, PhD
- Email: R.Avula@cgiar.org
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20006
- Recruiting
- International Food Policy Research Institute
-
Contact:
- Phuong Nguyen
- Phone Number: 202-826-4088
- Email: p.h.nguyen@cgiar.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mothers with children <2 years of age who are registered with the Anganwadi Center to receive services under the ICDS
- Pregnant women in first, second and third trimester who are registered with the Anganwadi Center to receive services under the ICDS
- Frontline health workers in the areas
- Supervisors/managers in the areas
- Key informants from the Panchayati Raj Institutions (PRI)
Exclusion Criteria:
- Women who are not currently registered with the local Anganwadi center to receive ICDS services
- Age <18
- Pregnant women with severe illness or complications
- Mothers with severely ill children
- Mental health problems that make it difficult for the respondent to answer the questions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A&T- intensive
|
Other Names:
|
No Intervention: A&T-non intensive
Only receives standard government services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of delivery of health and nutrition interventions
Time Frame: During pregnancy (about 9 months)
|
Proportion of beneficiaries receiving all ANC care items (weigh, blood sample taken, blood pressure measured, urine sample taken, abdomen checked),THR supplements and counseling.
|
During pregnancy (about 9 months)
|
Acceptability of reformulated take home ration by pregnant, lactating women and children
Time Frame: During pregnancy (about 9 months) and up to 24 months postpartum
|
Total standardized scores of acceptability to five THR organoleptic properties (taste, smell, texture, color, difficulty of eating), with higher scores representing higher acceptability.
|
During pregnancy (about 9 months) and up to 24 months postpartum
|
Use of reformulated take home ration by pregnant, lactating women and children
Time Frame: During pregnancy (about 9 months) and up to 24 months postpartum
|
Proportion of beneficiaries who consumed THR during pregnancy, lactation or early childhood
|
During pregnancy (about 9 months) and up to 24 months postpartum
|
Co-coverage of multiple interventions from across sectors
Time Frame: During pregnancy (about 9 months) and up to 24 months postpartum
|
|
During pregnancy (about 9 months) and up to 24 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MIYCN knowledge of FLWs
Time Frame: In the 6 months prior to interview date
|
Total standardized scores of correct answers to questions related to dietary diversity, micronutrients, and child feeding, with higher scores represent higher knowledge.
|
In the 6 months prior to interview date
|
Supportive supervision
Time Frame: In the 6 months prior to interview date
|
Total standardized scores of frequency and contents discussed during supervisory visits, with higher scores representing higher supervision.
|
In the 6 months prior to interview date
|
Decentralized programmatic decision-making using data
Time Frame: In the 6 months prior to interview date
|
Proportion of supervisors and frontline workers reporting use of any data (on THR distribution, growth monitoring, home visit, IFA/Ca/vaccine stocks etc) in the last 3 months.
|
In the 6 months prior to interview date
|
Panchayati Raj Members (PRI) member involvement
Time Frame: In the 6 months prior to interview date
|
Proportion of PRI members aware of all social safety net programs, ICDS and health services
|
In the 6 months prior to interview date
|
Mother IYCF knowledge and practices
Time Frame: During pregnancy (about 9 months) and up to 24 months postpartum
|
Total standardized scores of correct answers to questions related child feeding based on 2021 WHO recommendation, with higher scores representing higher knowledge.
|
During pregnancy (about 9 months) and up to 24 months postpartum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Phuong H Nguyen, PhD, International Food Policy Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00007490
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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