A Cluster Randomized Trial of the H2GO! Program

NCT04265794 | Active Not Recruiting

• 1 other identifier: H-39841
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

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

Conditions

Childhood Obesity

Keywords

Sugar-sweetened beverage; Boys and Girls Clubs; Youth empowerment; Water consumption

Outcome Measures

Primary Outcomes (1)

• Change in child body mass index (BMI) z score

  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.

  baseline, 12 months

Secondary Outcomes (2)

• Change in sugar-sweetened beverage intake

  Baseline, 12 months

• Change in water intake

  Baseline,12 months

Other Outcomes (1)

• Change in youth empowerment

  Baseline,12 months

Study Arms (2)

Intervention

EXPERIMENTAL

6-week community-based behavioral program consisting of 12 group-based weekly sessions (1-hour sessions twice a week) delivered by trained staff in the Boys and Girls Club setting. The intervention targets knowledge, attitudes, and skills related to sugar-sweetened beverage consumption and water consumption, with reduction in sugar-sweetened beverage consumption and increase in water consumption being the primary behavioral targets.

Behavioral: H2GO!

Comparison

NO INTERVENTION

Parent-child pairs in comparison sites will receive usual care (standard Boys and Girls Club programming) during the study and the intervention upon study completion.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 9-12 years
• Current member at a BGC study site
• Able to understand and communicate in English
• Able and willing to provide assent
• Parental/caregiver permission to participate

You may not qualify if:

• Parent or caregiver to a child member at a BGC study site
• years or older
• able to understand and communicate in English
• able and willing to provide consent
• no plans to change their child's BGC membership over the next 12 months
• \- has a medical condition that limits ability to change beverage consumption behaviors

Sponsors & Collaborators

• Boston University: lead
• University of Massachusetts, Worcester: collaborator
• Massachusetts Alliance of Boys and Girls Clubs: collaborator

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 34525990 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Wang, ScD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial (sites are randomized to the intervention or control condition)

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: October 22, 2020
• Primary Completion: June 4, 2025
• Study Completion: May 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)