Community-Based Nutrition Intervention for Adults With Malnutrition in Cambodia: A Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Minimum dietary diversity
研究概览
简要总结
The goal of this trial is to evaluate a community-based nutrition intervention for adults in Cambodia who are underweight or overweight/obese. This study will examine the effects of the nutrition intervention on participants' dietary diversity and will also assess how acceptable and feasible the intervention is to deliver in the community settings.
Health centers were randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a six-month, community-based nutrition intervention delivered by the Village Health Support Groups, while participants in the control group will not receive it.
Researchers will compare the two groups to determine the effect of the intervention on dietary diversity. Participants will complete study assessments at the beginning of the study, at 3 months, and at 7 months.
详细描述
This Hybrid-Type 1 effectiveness-implementation cluster randomized trial will be conducted in two provinces in Cambodia. Health centers will serve as units of randomization and will be allocated to either the intervention or control arm.
The primary aim of the study is to evaluate the effectiveness of a community-based nutrition intervention in improving dietary diversity among adults with underweight or overweight/obesity. Concurrently, the study also aims to examine the implementation evaluation of acceptability, adoption, appropriateness, feasibility, fidelity, and implementation cost of the intervention
The intervention will be delivered primarily by Village Health Support Groups with support and supervision from the health center staff. The implementation evaluation will use quantitative and qualitative methods to understand how the intervention is delivered and experienced and to identify factors that may influence its future implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to health center allocation where feasible.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years or older
- •Underweight (BMI <18.5 kg/m²) or overweight/obese (BMI ≥25 kg/m²)
- •Residing in a selected study village
- •Able and willing to provide written informed consent
排除标准
- •Unable to provide informed consent
- •Planning to move out of the study area during the intervention period
- •Medical or cognitive condition that would prevent participation in the intervention or completion of study assessments, as determined by the study team
研究组 & 干预措施
Community-Based Nutrition Intervention
干预措施: Community-Based Nutrition Intervention (Behavioral)
Control
结局指标
主要结局
Minimum dietary diversity
时间窗: Month 3 and Month 7
Minimum dietary diversity will be assessed using the Diet Quality Questionnaire (DQQ). Participants will be classified as meeting or not meeting minimum dietary diversity based on consumption of at least 5 of 10 defined food groups during the previous day or night.
次要结局
- Body Mass Index (BMI)(Month 3 and Month 7)
- Waist Circumference(Month 3 and Month 7)
- Nutrition Knowledge Score(Month 3 and Month 7)
- Health-Related Quality of Life: EQ-5D-5L Utility Index(Month 3 and Month 7)
- Self-Rated Health: EQ Visual Analogue Scale(Month 3 and Month 7)
研究者
Siyan Yi
Associate Professor
National University of Singapore