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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04111016
Acronym
RINEW
Enrollment
2823
Registered
2019-10-01
Start date
2019-04-06
Completion date
2020-09-16
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Development

Keywords

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

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.

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

Interventions

BEHAVIORALIntegrated child stimulation, nutrition, lead, arsenic, WASH intervention

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.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
University of California, Berkeley
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
BRAC University
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in session quality2nd, 6th and 12th month of the intervention; ~60 min per assessmentSemi-structured checklist for one pregnancy session and one mother-baby session in each health facility per assessment time period.
Change in proportion of planned session conductedEvery 2 weeks through study completion; ~10 minThis data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.
Change in number and proportion of eligible pregnant women and mother attendees at each sessionMonthly through study completion; ~15 min/assessmentThe attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.
Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions2nd, 6th and 12th month of the intervention; ~20 min per assessmentSemi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.
Change in determinants of session quality2nd, 6th and 12th month of the intervention; ~20 min per assessmentSemi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Change in determinants of session attendance2nd, 6th and 12th month of the intervention; ~20 min per assessmentSemi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees

Secondary

MeasureTime frameDescription
Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storageBaseline and 12 months after intervention; ~5 min/assessmentThis will be assessed with self-reported questions about behaviours regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage.
Change in individual-level attendance records and self-reportsMonthly through study completion; ~3 min/assessmentAttendance to group sessions over the intervention period will be recorded on participant-held attendance records. At the end line assessment participants will also be asked to show their intervention cards and report the number of sessions they have attended over the previous 12 months.
Change in responsive feeding and interactions during mealtimeBaseline and 12 months after intervention; ~5 min/assessmentThis will be assessed with self-reported interactions mother/caregiver follow during feeding (complementary foods) to their 6-24 months old children
Change in availability and accessibility of safe water storage containers, hygienic toilet, handwashing station, child potty (for >6 months to 2 year old children), and covers for cooked food.Baseline and 12 months after intervention; ~5 min/assessmentThis will be measured with self-reported behaviors, as well as observations of water storage facilities, latrine quality, handwashing station and child potty.
Change in caregiver early child development knowledge and practicesBaseline and 12 months after intervention; ~15 min/assessmentA modified version of the Family Care Indicators (FCI), including self-reported behaviors and knowledge and observations during the interview, will be used to measure childhood development knowledge and practices. The FCI has the following sub-scales: 1) household books (number); 2) magazines or newspapers in the household (number), 3) sources of play materials (number of 3 possible categories), 4) varieties of play materials (number of 7 possible categories), 5) play activities (number of 6 possible categories). The scores from each sub-scale are summed to calculate the total score. For all sub-scales and the total score, higher scores are associated with a better child care. Investigators will also assess 11 additional observational items including observations of the home environment, and parental responsiveness and acceptance during the interview. Positive responses are summed to create an observation score.
Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.Baseline and 12 months after intervention; ~15 min/assessmentChild dietary diversity will be calculated based on the number of 7 different food groups consumed by the child yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child. Minimum acceptable diet is determined by the child's dietary diversity and meal frequency.
Change in maternal dietary diversityBaseline and 12 months after intervention; ~5 min/assessmentMaternal dietary diversity indicated by the number of 10 different food groups consumed by the mother yesterday. This will be determined based on a maternal-reported 24 hour recall of all foods consumed by the mother and the child.
Change in maternal depressive symptomsBaseline and 12 months after intervention; ~5 min/assessmentCaregiver mental health will be measured using the Center for Epidemiologic Studies Depression scale (CESD), which includes 20 questions about symptoms experienced in the previous week. Number of days experiencing each symptom in the last week is converted into a score: 0= 0 or less than 1 day; 1= 1-2 days; 2= 3-4 days, 3=5-7 days, and the total score is a sum of negative symptoms experienced (positive items are reverse scored). The score ranges from 0-60, with higher scores indicating more depressive symptoms experienced.
Change in maternal knowledge regarding lead, nutrition, WASH, and arsenicBaseline and 12 months after intervention; ~5 min/assessmentThis will be assessed with self-report questions about knowledge about lead exposure and prevention, nutrition, WASH, and arsenic exposure.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026