The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Child Percent of the 95th Body Mass Index Percentile
研究概览
简要总结
Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.
详细描述
In Aim 1, the investigators will conduct a community readiness assessment for COACH in 50 community centers serving rural, minority, and low-income families in middle TN. In 25 randomly selected community centers, the investigators will use a systematic process to adapt the intervention protocol based on the assessment results, while maintaining fidelity to COACH's core components. In Aim 2, in a cluster-randomized trial, the investigators will test the comparative effectiveness of each implementation strategy (adaptation vs. original program) on the implementation outcomes of reach, adoption, implementation, and maintenance. In Aim 3, the investigators will test the comparative effectiveness of the adapted and original intervention.
This research is innovative because it uses adaptation science as a potential solution to reduce health disparities in childhood obesity. By testing this intervention in a community resource available to 230 million Americans (community centers), the investigators aim to create a scalable obesity intervention that could be implemented in traditionally underserved populations across the country. This study will also develop and test a theory-based process for adapting behavioral interventions for both obesity and other health outcomes among diverse rural and urban communities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child with an age ≥ 6 years and < 12 years
- •Child body mass index ≥95th percentile for age and sex on standardized CDC growth curves
- •Index parent/legal guardian with an age ≥18 years
- •Parent and child speak English or Spanish
- •Family resides within or frequently visit selected zip codes within Middle TN surrounding the partnering community centers;
- •Have parental commitment to participate in a 6-month study;
- •Have the ability to view online trainings
- •Complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items.
排除标准
- •Participant child has been diagnosed with Down Syndrome, Autism, or any other developmental disorders that impact metabolism or behaviors that would preclude participation in group physical activity settings;
- •Either the participant caregiver or child is unable to participate in light to moderate physical activity;
- •Participant caregiver has a serious mental or neurologic illness that impairs ability to consent/participate.
结局指标
主要结局
Child Percent of the 95th Body Mass Index Percentile
时间窗: 6 months post randomization
Calculated from CDC growth curves
次要结局
- Child Percent of the 95th Body Mass Index Percentile(6 weeks post randomization)
研究者
Bill Heerman
Associate Professor of Pediatrics
Vanderbilt University Medical Center