Empowerment as a Mechanism for Change in Childhood Obesity Prevention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4,999
- 试验地点
- 1
- 主要终点
- Modified change in BMI z-score
研究概览
简要总结
The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.
详细描述
This evaluation will test the effectiveness of a family-focused intervention, Communities for Healthy Living (CHL), implemented through Head Start. Over 20% of preschool-aged children in the US experience overweight or obese. Because obesity prevention depends heavily on the adoption of healthy lifestyle behaviors early in life, preventive efforts offer a higher promise for success if they are family-centered. Effective family-centered interventions for obesity prevention in preschool-aged children, however, remain elusive. While a number of interventions have shown positive effects on child Body Mass Index (BMI), results are inconsistent and short term effects are not maintained. What is more, because families at greatest risk of childhood obesity - including low-income, single-parent, and ethnic minority families - are the most difficult to recruit and retain, results are often limited in their applicability to high risk populations.
In response, the researchers have partnered with Head Start to develop and test a new approach to family-centered childhood obesity prevention that addresses family engagement upfront. The CHL program will be refined and rigorously tested for efficacy in collaboration with Head Start programs in the greater Boston area, which collectively serve over 2000 low-income children each year. Building on a previous pilot study, the investigators will broaden the parent-centered Community Based Participatory Research approach and include Head Start staff in the decision making and implementation process, refine intervention components, and expand technical assistance protocols to support Head Start ownership of CHL while ensuring implementation fidelity. In addition, consistent with the overarching theoretical framework (Family Ecological Model), neighborhood-level socioeconomic, food and physical activity environments around family homes and examine their impact on intervention outcomes will be measured to inform future scale up efforts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary Outcome Measures
- •Enrolled in a participating Head Start program
- •Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)
排除标准
- •Those not meeting inclusion criteria
- •Secondary Outcome Measures
- •Enrolled in a participating Head Start program
- •Age 33 months to 5 years
- •Children not enrolled at a participating Head Start program
- •Children less than 29 months or older than 59 months by Sept 1
研究组 & 干预措施
Intervention
Sites randomized to the intervention group will receive the following:
- Parents Connect for Healthy Living (PConnect)
- Enhanced Nutrition Support
- Media Resources
干预措施: Media Resources (Behavioral)
Control
Control sites will not receive any intervention components (i.e., standard practice).
Intervention
Sites randomized to the intervention group will receive the following:
- Parents Connect for Healthy Living (PConnect)
- Enhanced Nutrition Support
- Media Resources
干预措施: Enhanced Nutrition Support (Behavioral)
Intervention
Sites randomized to the intervention group will receive the following:
- Parents Connect for Healthy Living (PConnect)
- Enhanced Nutrition Support
- Media Resources
干预措施: Parents Connect for Healthy Living (PConnect) (Behavioral)
结局指标
主要结局
Modified change in BMI z-score
时间窗: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)
BMI of a child is expressed relative to the median BMI in units of ½ of the distance between 0 and +2 z- scores. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5703793/
Change in Child BMI-z score
时间窗: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned
Change in child BMI-z score
次要结局
- Change in child physical activity(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
- Change in child fruit and vegetable intake(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
- Change in child sleep duration(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
- Change in child screen-time(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
- Summer weight gain(Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year)
- Change in child sugar-sweetened beverage intake(Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned)
研究者
Kirsten
Donahue and DiFelice Professor of Social Work
Boston College