NCT05443997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

February 17, 2022

Last Update Submit

April 29, 2025

Conditions

Keywords

Maternal NutritionSupportive supervisionMIYCN behaviorsSystem strengthening

Outcome Measures

Primary Outcomes (4)

  • Quality of delivery of health and nutrition interventions

    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

    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

    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

    * For pregnant women: Proportion of pregnant women receiving at least 7 out of 14 interventions (\>=4 ANC, received IFA, tetanus, weighed during ANC, breast feeding and cord counselling, received THR, health \& nutrition education, mosquito net, improved sanitation, clean cooking fuel, met ASHA worker at home, met AWW at home) * For mothers with children \<2y: Proportion of mother-child pairs receiving at least 12 out of 24 interventions (≥ 4 ANC visits, received IFA, tetanus, deworming, weighed during ANC, breastfeeding and cord-care counselling, food supplementation, health and nutrition education, mosquito net, institutional birth, postnatal care for mothers and babies, postnatal food supplementation, postnatal health and nutrition education, counselling on child growth, deworming, pediatric IFA, Vitamin A supplementation, child weighing, home visits by AWW or ASHW, HHs with improved sanitation facility and cooking fuel)

    During pregnancy (about 9 months) and up to 24 months postpartum

Secondary Outcomes (5)

  • MIYCN knowledge of FLWs

    In the 6 months prior to interview date

  • Supportive supervision

    In the 6 months prior to interview date

  • Decentralized programmatic decision-making using data

    In the 6 months prior to interview date

  • Panchayati Raj Members (PRI) member involvement

    In the 6 months prior to interview date

  • Mother IYCF knowledge and practices

    During pregnancy (about 9 months) and up to 24 months postpartum

Study Arms (2)

A&T- intensive

EXPERIMENTAL

1. Capacity building will involve offsite training conducted by Vitamin Angels and short capsule trainings delivered by government staff 2. Supportive supervision will involve training and handholding of supervisors on use of job aids and mobile application 3. Strategic use of data will involve setting up processes to review key data, review meetings and short trainings on gap areas. 4. Engagement of Panchayati Raj Institutions (PRI) around convergence where PRI members will be equipped with job aids, including an App 5. Improved food supplements where THR offering for pregnant and lactating women and children 6 months and older will be revisited and improved solutions will be explored.

Behavioral: MIYCN capacity building

A&T-non intensive

NO INTERVENTION

Only receives standard government services

Interventions

* MIYCN knowledge, skills, and motivation of FLWs * Supportive supervision * Decentralized programmatic decision-making using data * PRI member involvement * Availability of THR * IYCF knowledge and practices

Also known as: 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, All intervention component together
A&T- intensive

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Washington D.C., District of Columbia, 20006, United States

Location

Study Officials

  • Phuong H Nguyen, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The implementation research study uses a cluster-randomized design with cross-sectional baseline and endline surveys
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

July 5, 2022

Study Start

March 22, 2022

Primary Completion

May 30, 2023

Study Completion

July 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations