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A Cluster Randomized Trial of the H2GO! Program

Primary Purpose

Childhood Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H2GO!
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Sugar-sweetened beverage, Boys and Girls Clubs, Youth empowerment, Water consumption

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Comparison

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in sugar-sweetened beverage intake
Sugar-sweetened beverage intake will be assessed by the self-report Beverage Intake Questionnaire (BEV-Q). Participants will report the type and quantity of sugar-sweetened beverages they consumed over the past day
Change in water intake
Water intake will be assessed by the self-report Beverage Intake Questionnaire (BEV-Q). Participants will report the quantity of water they consumed over the past day.

Full Information

First Posted
February 10, 2020
Last Updated
January 27, 2023
Sponsor
Boston University
Collaborators
University of Massachusetts, Worcester, Massachusetts Alliance of Boys and Girls Clubs
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1. Study Identification

Unique Protocol Identification Number
NCT04265794
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
University of Massachusetts, Worcester, Massachusetts Alliance of Boys and Girls Clubs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Sugar-sweetened beverage, Boys and Girls Clubs, Youth empowerment, Water consumption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial (sites are randomized to the intervention or control condition)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
H2GO!
Intervention Description
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 Outcome Measure Information:
Title
Change in child body mass index (BMI) z score
Description
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.
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in sugar-sweetened beverage intake
Description
Sugar-sweetened beverage intake will be assessed by the self-report Beverage Intake Questionnaire (BEV-Q). Participants will report the type and quantity of sugar-sweetened beverages they consumed over the past day
Time Frame
Baseline, 12 months
Title
Change in water intake
Description
Water intake will be assessed by the self-report Beverage Intake Questionnaire (BEV-Q). Participants will report the quantity of water they consumed over the past day.
Time Frame
Baseline,12 months
Other Pre-specified Outcome Measures:
Title
Change in youth empowerment
Description
8-item survey that asks youth to report their confidence in a range of situations using a 10-point Likert scale
Time Frame
Baseline,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Child participant inclusion criteria 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 Child participant exclusion criteria - Has a medical condition that limits ability to change beverage consumption behaviors Parent participant inclusion criteria Parent or caregiver to a child member at a BGC study site 18 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 Parent participant exclusion criteria - has a medical condition that limits ability to change beverage consumption behaviors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Wang, ScD
Phone
617-910-6041
Email
mlwang@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Selenne Salatorre, MPH
Phone
(617) 414-1357
Email
salatorr@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Wang, ScD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Wang, ScD
Phone
617-910-6041
Email
mlwang@bu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34525990
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.
Results Reference
derived

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A Cluster Randomized Trial of the H2GO! Program

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