Clinical trial

A Cluster Randomized Trial of the H2GO! Program

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04265794

Active, not recruitingNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age9 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity

Full registry 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

Treatments and study arms

H2GO!

Behavioral

Child participants will participate in a 6-week behavioral intervention consisting of 12 group-based weekly sessions (1-hour sessions twice a week) delivered by trained staff in the Boys and Girls Club setting. Each week consisted of a 1-hour health session and a 1-hour narrative session (delivered on separate days). Child participants will also receive reusable water bottles and a pictorial intervention booklet, which includes worksheets and parent-child take-home activities targeting attitudes, knowledge, and skills related to sugar-sweetened beverage and water consumption. Parent participants will be exposed to intervention messages (e.g., reduce SSB intake) through weekly parent-child take-home activities, child sharing of narratives produced, and a culminating open house event.

Primary outcomes

Change in child body mass index (BMI) z scorebaseline, 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Boston University School of Public Health🇺🇸 Boston, Massachusetts, United States