Feasibility of Implementing RINEW Through the Government System

NCT04111016 | Completed

• 1 other identifier: 50733
• Study Type: observational
• Target: 2,823
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Childhood Development

Keywords

Early childhood development; Responsive parenting; Nutrition; WASH; Stimulation; Parenting; Integrated Interventions

Outcome Measures

Primary Outcomes (6)

• Change in session quality

  Semi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.

  2nd, 6th and 12th month of the intervention; ~60 min per assessment

• Change in proportion of planned session conducted

  This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.

  Every 2 weeks through study completion; ~10 min

• Change in number and proportion of eligible pregnant women and mother attendees at each session

  The attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.

  Monthly through study completion; ~15 min/assessment

• Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions

  Semi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.

  2nd, 6th and 12th month of the intervention; ~20 min per assessment

• Change in determinants of session quality

  Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees

  2nd, 6th and 12th month of the intervention; ~20 min per assessment

• Change in determinants of session attendance

  Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees

  2nd, 6th and 12th month of the intervention; ~20 min per assessment

Secondary Outcomes (9)

• Change in individual-level attendance records and self-reports

  Monthly through study completion; ~3 min/assessment

• Change in caregiver early child development knowledge and practices

  Baseline and 12 months after intervention; ~15 min/assessment

• Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.

  Baseline and 12 months after intervention; ~15 min/assessment

• Change in maternal dietary diversity

  Baseline and 12 months after intervention; ~5 min/assessment

• Change in maternal depressive symptoms

  Baseline and 12 months after intervention; ~5 min/assessment

Study Arms (1)

Participants able to access the intervention

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.

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

Interventions

Integrated child stimulation, nutrition, lead, arsenic, WASH intervention BEHAVIORAL

The 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.

Participants able to access the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chatmohar sub-district of Pabna has been selected to implement the integrated intervention through the government system. All Chatmahor residents with children \<2 or families of pregnant women are eligible to participate (attend health facilities offering the intervention) The selection of Chatmohar was based on meeting the following criteria: i. Communication status from Dhaka: should have a good by road communication (Bus/train) ii. Presence of a local champion in the government health system: UH\&FPO should be known and enthusiastic to implement an integrated intervention in the sub-district iii. Low percentage of vacant posts for government frontline health workers: \<25% vacant posts iv. Most of the community clinic should be active v. Receptive and less conservative community vi. Community that is exposed to arsenic and lead contamination

You may qualify if:

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

You may not qualify if:

• \) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother.
• \) Government health workers who are participating in the facilitation or supervision of RINEW sessions
• \) Child, mother, or primary caregiver with impaired cognitive development, or hearing, vision, speech impaired child or mother

Sponsors & Collaborators

• Stanford University: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• University of California, Berkeley: collaborator
• Johns Hopkins University: collaborator
• BRAC University: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (2)

• Sultana J, Pitchik HO, Shoab AK, Huda TMN, Hasan R, Akter F, Jahir T, Khobair Hossain M, Das JB, Amin MR, Yeasmin F, Khan R, Forsyth JE, Kwong LH, Rashid J, Ashrafee S, Rahman M, Mridha MK, Tofail F, Winch PJ, Luby SP, Fernald LCH. Evaluation of a multicomponent child development intervention delivered through the government health system: a feasibility study. BMJ Glob Health. 2025 Jul 20;10(7):e018736. doi: 10.1136/bmjgh-2024-018736.

  PMID: 40685160 DERIVED

• Winters S, Pitchik HO, Akter F, Yeasmin F, Jahir T, Huda TMN, Rahman M, Winch PJ, Luby SP, Fernald LCH. How does women's empowerment relate to antenatal care attendance? A cross-sectional analysis among rural women in Bangladesh. BMC Pregnancy Childbirth. 2023 Jun 13;23(1):436. doi: 10.1186/s12884-023-05737-9.

  PMID: 37312017 DERIVED

MeSH Terms

Interventions

Nutritional Status; Lead; Arsenic

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Metals, Heavy; Elements; Inorganic Chemicals; Metals; Metalloids

Study Officials

• Stephen P Luby, Dr.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: October 1, 2019
• Study Start: April 6, 2019
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

BA (1)