Exploring the Feasibility of Implementing an Integrated Nutrition, Early Childhood Development and WASH (RINEW) Intervention Through the Government Health System: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,823
- 试验地点
- 1
- 主要终点
- Change in number and proportion of eligible pregnant women and mother attendees at each session
研究概览
简要总结
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.
详细描述
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:
- 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
- Identify barriers, facilitators/opportunities, and pathway for scale up of the RINEW intervention through government health system
- Assess the coverage of the intervention in the target population
- Assess the uptake of recommended behaviors in the target population
To reach these objectives the investigators will
- Train government health workers to deliver the intervention at government health facilities
- Conduct a clinic-based process evaluation using both quantitative and qualitative methods at multiple time points during the 12-months intervention
- Conduct population-based quantitative baseline and endline assessments to assess intervention coverage and uptake
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in number and proportion of eligible pregnant women and mother attendees at each session
时间窗: Monthly through study completion; ~15 min/assessment
The attendance numbers will be collected at each pregnancy and mother-baby session, and reported to the study team on a monthly basis.
Change in determinants of session attendance
时间窗: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
Change in session quality
时间窗: 2nd, 6th and 12th month of the intervention; ~60 min per assessment
Semi-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 conducted
时间窗: Every 2 weeks through study completion; ~10 min
This data will be reported by the intervention facilitators and collected by the intervention supervisors on a monthly basis.
Change in satisfaction of trained health workers with training and intervention implementation: Semi-structured individual interviews and focus group discussions
时间窗: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structured individual interviews and focus group discussions with intervention implementors and their supervisors.
Change in determinants of session quality
时间窗: 2nd, 6th and 12th month of the intervention; ~20 min per assessment
Semi-structure individual interviews and focus group discussions with a purposive sample of intervention implementors, their supervisors, and intervention attendees
次要结局
- Change in child dietary diversity, child minimum meal frequency and minimum acceptable diet.(Baseline and 12 months after intervention; ~15 min/assessment)
- 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 maternal depressive symptoms(Baseline and 12 months after intervention; ~5 min/assessment)
- Change in self-reported behaviour regarding prevention of lead contamination, disposal of human and chicken feces, water and food storage(Baseline and 12 months after intervention; ~5 min/assessment)
- Change in responsive feeding and interactions during mealtime(Baseline and 12 months after intervention; ~5 min/assessment)
- Change in maternal dietary diversity(Baseline and 12 months after intervention; ~5 min/assessment)
- Change in maternal knowledge regarding lead, nutrition, WASH, and arsenic(Baseline and 12 months after intervention; ~5 min/assessment)
- 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/assessment)
研究者
Stephen P Luby
Professor of Medicine (Infectious Diseases)
Stanford University