跳至主要内容
临床试验/NCT04265794
NCT04265794进行中(未招募)不适用

Preventing Childhood Obesity Through Youth Empowerment: A Cluster RCT of the H2GO! Program

Boston University2 个研究点 分布在 1 个国家目标入组 824 人开始时间: 2020年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
824
试验地点
2
主要终点
Change in child body mass index (BMI) z score

研究概览

简要总结

This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial [RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants

详细描述

Over one-third of children in the U.S. are overweight or obese and at risk for short-term and long-term health consequences, including diabetes, hypertension, heart disease and certain types of cancer. Substantial evidence exists on reducing sugar-sweetened beverage (SSB) consumption as a critical dietary target for childhood obesity prevention. Efficacious behavioral interventions targeting SSBs are lacking, particularly among low-income and ethnic minority early and pre-adolescent youth who have higher SSB intake and obesity risk. Youth empowerment interventions hold potential for catalyzing behavior change in childhood obesity intervention contexts and may be particularly engaging for low-income and ethnic minority youth. However, few studies of youth empowerment health interventions have utilized rigorous study designs or examined empowerment as a mediator/mechanism of change. To this gap, the research team has worked collaboratively with Boys and Girls Clubs of America (BGCs), a national system of after-school care that reaches 4 million youth annually, to develop and pilot-test a community-based youth empowerment intervention on reducing SSB intake and preventing childhood obesity. Grounded in Empowerment Theory, the intervention targets SSB consumption through health sessions that empower youth through developing their confidence and skills; narrative sessions that empower youth through cultivating critical thinking, and youth-led activities that empower youth through opportunities to produce change within their families. The resulting H2GO! intervention is designed to be delivered within BGCs by BGC staff. Building on the successful pilot study of H2GO!, the research team is now positioned to test the efficacy of the H2GO! intervention in collaboration with the BGC network in MA, which collectively serves over 160,000 children each year. Using a cluster-randomized design, a total of 10 BGC sites will be randomly assigned to the H2GO! intervention or a wait-list, usual care condition. A total of 450 parent-child pairs (N=45 parent-child pairs per site) will be enrolled. Data will be collected at baseline, 2 months, 6 months, and 12 months and include child anthropometrics, SSB and water intake, and youth empowerment. Specific aims of the proposal include: 1) test the efficacy of the H2GO! intervention on child BMI z scores using a cluster randomized controlled trial; 2) test the efficacy of the H2GO! intervention on child SSB and water intake; 3) examine youth empowerment as a mediator of intervention effects. Findings from this proposal will provide evidence of youth empowerment as an approach to reduce SSB intake and obesity risk and contribute to a long-term goal of producing an intervention model for childhood obesity prevention that is well-positioned for dissemination through youth-based settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in child body mass index (BMI) z score

时间窗: baseline, 12 months

Trained staff will obtain child participants' height (inches) and weight (pounds) using standardized equipment. Height and weight will then be used to calculate BMI (kg/m\^2) and BMI z scores.

次要结局

  • Change in water intake(Baseline,12 months)
  • Change in sugar-sweetened beverage intake(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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