Clinical Trials Directory

Trials / Completed

CompletedNCT04111016

Feasibility of Implementing RINEW Through the Government System

Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
2,823 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.

Detailed description

The RINEW intervention is a group-based integrated nutrition, responsive stimulation, and WASH intervention with a goal to improve child development outcomes. The intervention is delivered in group sessions to pregnant women and mothers or primary caregivers of children under 24 months of age. The RINEW intervention was tested in a pilot cluster-randomized control study in Bangladesh, where the investigators found the intervention group had better self-reported knowledge and behavior related to early child development. The investigators aim to implement this intervention through the government health system in one sub-district of Bangladesh, and assess the feasibility of delivering the intervention in this way, as well as the uptake of the intervention in the target population. The facilitators will be trained by the study team, and the intervention will be implemented in community-level health centers, facilitated by government health workers. The specific objectives of this work are to: 1. Assess the feasibility (i.e. satisfaction of providers, perceived appropriateness of content and practicability of session delivery, population demand for sessions, quality and frequency of implementation, and preparedness of health system) of implementing the RINEW intervention through the government health system 2. Identify barriers, facilitators/opportunities, and pathway for scale up of the RINEW intervention through government health system 3. Assess the coverage of the intervention in the target population 4. Assess the uptake of recommended behaviors in the target population To reach these objectives the investigators will 1. Train government health workers to deliver the intervention at government health facilities 2. Conduct a clinic-based process evaluation using both quantitative and qualitative methods at multiple time points during the 12-months intervention 3. Conduct population-based quantitative baseline and endline assessments to assess intervention coverage and uptake

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntegrated child stimulation, nutrition, lead, arsenic, WASH interventionThe content of the intervention curriculum was developed considering the needs of the specific ages of the children attending the group, as well as the feasibility of delivering the package in the community. The pregnancy module encompasses information on significance of prenatal care for child development, physiological symptoms and solutions, maternal diet, education on kangaroo mother care (KMC), breast feeding, thinking healthy, hygiene, and lead and arsenic prevention. The curriculum for lactating mothers focuses on specialized messages for 4 age groups of children: 0-5 months, 6-11 months, 12-18 months and 19-24 months. The overall package includes information regarding WASH, psychosocial stimulation, nutrition, maternal mental health, lead and arsenic. As research evidence showed that psychosocial stimulation provided for 10 or 12 months can significantly improve child development, the psychosocial stimulation component is included in every fortnightly session.

Timeline

Start date
2019-04-06
Primary completion
2020-09-16
Completion
2020-09-16
First posted
2019-10-01
Last updated
2022-05-17

Locations

1 site across 1 country: Bangladesh

Source: ClinicalTrials.gov record NCT04111016. Inclusion in this directory is not an endorsement.