Clinical trial NCT05443997: Systems Strengthening Interventions to Improve Quality and Co-coverage of Nutrition Services in Gujarat, India
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Nutrition
Keywords: Maternal Nutrition
Supportive supervision
MIYCN behaviors
System strengthening
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The implementation research study uses a cluster-randomized design with cross-sectional baseline and endline surveys
Primary purpose: PREVENTION

Brief summary: Progress on child growth outcomes such as stunting requires both direct and indirect actions across multiple sectors. Recognizing the importance of multisector approaches in reducing child undernutrition, Alive \& Thrive (A\&T) India aims to improve the quality of health and nutrition services, as well as their convergence at the household level with other available nutrition-sensitive services, in order to improve MIYCN behaviors, and ultimately decrease malnutrition in Gujarat. In line with government priorities, A\&T designed a suite of system strengthening interventions including capacity building, supportive supervision, strategic use of data, improved food supplementation and engagement with local governance to improve the quality and co-coverage of nutrition-relevant services in three districts in Gujarat. This proposed evaluation aims to assess the feasibility of integrating multi-sectoral interventions using a cluster-randomized design with cross-sectional baseline and endline surveys.

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:

1. To what extent and through which pathways can overall system strengthening approaches improve quality of delivery of health and ICDS services?
2. 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?
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of delivery of health and nutrition interventions
timeFrame: During pregnancy (about 9 months)
measure: Acceptability of reformulated take home ration by pregnant, lactating women and children
timeFrame: During pregnancy (about 9 months) and up to 24 months postpartum
measure: Use of reformulated take home ration by pregnant, lactating women and children
timeFrame: During pregnancy (about 9 months) and up to 24 months postpartum
measure: Co-coverage of multiple interventions from across sectors
timeFrame: During pregnancy (about 9 months) and up to 24 months postpartum
Secondary outcomes:
measure: MIYCN knowledge of FLWs
timeFrame: In the 6 months prior to interview date
measure: Supportive supervision
timeFrame: In the 6 months prior to interview date
measure: Decentralized programmatic decision-making using data
timeFrame: In the 6 months prior to interview date
measure: Panchayati Raj Members (PRI) member involvement
timeFrame: In the 6 months prior to interview date
measure: Mother IYCF knowledge and practices
timeFrame: During pregnancy (about 9 months) and up to 24 months postpartum
Other outcomes:
Locations:
city: Washington
country: United States
facility: International Food Policy Research Institute
state: District of Columbia
Study officials:
affiliation: International Food Policy Research Institute
name: Phuong H Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
References: