Feasibility of Implementing RINEW Through the Government System

Stanford University

Status: Completed

Conditions: Early Childhood Development

Treatments: Behavioral: Integrated child stimulation, nutrition, lead, arsenic, WASH intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04111016

50733

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,823 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for household assessment of study participants:

1. mother or primary caregiver of a child 6-24 months old,
2. living in Chatmohar sub-district
3. planning to reside in that area for at least one year (Baseline), or
4. having lived in the area for at least 1 year (Endline).

Exclusion criteria for household assessment of study participants:

1. Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother.

Inclusion criteria for interviews with study facilitators

1. Government health workers who are participating in the facilitation or supervision of RINEW sessions

Inclusion criteria for qualitative interviews with intervention attendees 1) Mothers or primary caregivers eligible for the intervention sessions

Exclusion criteria for qualitative interviews with intervention attendees

1. Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother

Trial design

2,823 participants in 1 patient group

Participants able to access the intervention

Description:

These group sessions will be delivered by government health workers, and include behavioral recommendations about responsive stimulation, nutrition, water, sanitation and hygiene, lead poisoning prevention, and maternal mental health. Pregnancy groups and caregiver-child groups will be held separately, and mothers and caregivers who attend sessions will receive simple toys and books to use during some of the intervention sessions, which they will be permitted to take home with them. In addition, mothers and caregivers who attend intervention sessions will receive 30 sachets containing 1 gm multiple micronutrient powder (MNP) per month. Beginning as soon as pregnancy is confirmed, health workers will facilitate pregnant women in receiving the Iron and Folic acid supplements already provided by the Government of Bangladesh and will continue the supplementation up to three months post-partum period.

Treatment:

Behavioral: Integrated child stimulation, nutrition, lead, arsenic, WASH intervention