Clinical trial NCT04265794: A Cluster Randomized Trial of the H2GO! Program
Official title: Preventing Childhood Obesity Through Youth Empowerment: A Cluster RCT of the H2GO! Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Keywords: Sugar-sweetened beverage
Boys and Girls Clubs
Youth empowerment
Water consumption
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Massachusetts Alliance of Boys and Girls Clubs
First posted: 2020-02-12
Enrollment: 824
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial (sites are randomized to the intervention or control condition)
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Child participant inclusion criteria

1. Ages 9-12 years
2. Current member at a BGC study site
3. Able to understand and communicate in English
4. Able and willing to provide assent
5. Parental/caregiver permission to participate

Child participant exclusion criteria - Has a medical condition that limits ability to change beverage consumption behaviors

Parent participant inclusion criteria

1. Parent or caregiver to a child member at a BGC study site
2. 18 years or older
3. able to understand and communicate in English
4. able and willing to provide consent
5. no plans to change their child's BGC membership over the next 12 months

Parent participant exclusion criteria

- has a medical condition that limits ability to change beverage consumption behaviors

Primary outcomes:
measure: Change in child body mass index (BMI) z score
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Change in sugar-sweetened beverage intake
timeFrame: Baseline, 12 months
measure: Change in water intake
timeFrame: Baseline,12 months
Other outcomes:
measure: Change in youth empowerment
timeFrame: Baseline,12 months
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Monica Wang, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang ML, Sprague Martinez LS, Weinberg J, Alatorre S, Lemon SC, Rosal MC. A youth empowerment intervention to prevent childhood obesity: design and methods for a cluster randomized trial of the H2GO! program. BMC Public Health. 2021 Sep 15;21(1):1675. doi: 10.1186/s12889-021-11660-5.