Clinical trial NCT04111016: Feasibility of Implementing RINEW Through the Government System
Official title: Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Childhood Development
Keywords: Early childhood development
Responsive parenting
Nutrition
WASH
Stimulation
Parenting
Integrated Interventions
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: University of California, Berkeley
name: Johns Hopkins University
name: BRAC University
First posted: 2019-10-01
Enrollment: 2823
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility 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

Primary outcomes:
measure: Change in session quality
timeFrame: 2nd, 6th and 12th month of the intervention; ~60 min per assessment
measure: Change in proportion of planned session conducted
timeFrame: Every 2 weeks through study completion; ~10 min
measure: Change in number and proportion of eligible pregnant women and mother attendees at each session
timeFrame: Monthly through study completion; ~15 min/assessment
measure: Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions
timeFrame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
measure: Change in determinants of session quality
timeFrame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
measure: Change in determinants of session attendance
timeFrame: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Secondary outcomes:
measure: Change in individual-level attendance records and self-reports
timeFrame: Monthly through study completion; ~3 min/assessment
measure: Change in caregiver early child development knowledge and practices
timeFrame: Baseline and 12 months after intervention; ~15 min/assessment
measure: Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.
timeFrame: Baseline and 12 months after intervention; ~15 min/assessment
measure: Change in maternal dietary diversity
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
measure: Change in maternal depressive symptoms
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
measure: Change in maternal knowledge regarding lead, nutrition, WASH, and arsenic
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
measure: Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
measure: 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.
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
measure: Change in responsive feeding and interactions during mealtime
timeFrame: Baseline and 12 months after intervention; ~5 min/assessment
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: Stanford University
name: Stephen P Luby, Dr.
role: PRINCIPAL_INVESTIGATOR
References: