A Cluster Randomized Trial of the H2GO! Program

RECRUITING

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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

Conditions:

🦠 Childhood Obesity

🗓️ Study Start (Actual) 22 October 2020

🗓️ Primary Completion (Estimated) June 2025

✅ Study Completion (Estimated) January 2026

👥 Enrollment (Estimated) 900

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 9 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 10 February 2020
First Submitted that Met QC Criteria 10 February 2020
First Posted 12 February 2020

Study Record Updates