Childhood ObesityNCT04265794
A Cluster Randomized Trial of the H2GO! Program
A study testing H2GO! in people with Childhood Obesity, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- H2GO!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Official title: Preventing Childhood Obesity Through Youth Empowerment: A Cluster Randomized Trial of the H2GO! Program
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 plan to recruit 45 parent-child pairs per site for a total of 450 parent-child pairs/dyads. 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
Read the 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 Massachusetts, 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 dyads 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.
- Conditions
- Childhood Obesity
- Being tested
- H2GO!
- Keywords
- Sugar-sweetened beverage, Boys and Girls Clubs, Youth empowerment, Water consumption
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2GO!Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 (SSB) consumption and increase in water consumption being the primary behavioral targets. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index (BMI) z Scores
Trained staff obtained child participants' height (inches) and weight (pounds) using standardized equipment and calculated using the Centers for Disease Control (CDC) 2000 sex- and age-specific growth charts. A BMI z-score of 0 represents the age- and sex-specific population mean, with positive values indicating BMI above the reference population mean and negative values indicating BMI below the reference population mean. Lower BMI z-scores represent a more favorable outcome in this childhood obesity prevention trial, while higher BMI z-scores indicate relatively greater adiposity
Measured: baseline, 12 months
Secondary outcomes (2)
Sugar-sweetened Beverage Intake
Sugar-sweetened beverage intake will be assessed by the self-report Beverage Intake Questionnaire (BEV-Q). Participants will report the quantity of sugar-sweetened beverages they consumed over the past day reported in fluid ounces per day.
Measured: Baseline, 12 months
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 in fluid ounces per day.
Measured: Baseline,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start22 Oct 2020
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial (sites are randomized to the intervention or control condition)
- Masking
- None (open label)
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Massachusetts Alliance of Boys and Girls Clubs, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Monica Wang, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265794
- Sponsor's protocol ID
- H-39841
- Other IDs
- 1R01DK120713-01A1
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2020
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang ML, Alatorre S, Schwarz AG, Weinberg J, Sprague Martinez L, Aldworth J, Kadel R, Rosal MC, Lemon SC. A Community-Based Behavioral Intervention and Body Mass Index in School-Aged Children: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638188. doi: 10.1001/jamanetworkopen.2026.38188.
PubMed 42853568Wang 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.
PubMed 34525990
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Childhood Obesity Through Youth Empowerment: A Cluster Randomized Trial of the H2GO! Program
- ClinicalTrials.gov ID
- NCT04265794
- Acronym / sponsor ID
- H-39841
- Conditions
- Childhood Obesity
- Keywords
- Sugar-sweetened beverage, Boys and Girls Clubs, Youth empowerment, Water consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Massachusetts Alliance of Boys and Girls Clubs, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 16 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 plan to recruit 45 parent-child pairs per site for a total of 450 parent-child pairs/dyads. 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 Massachusetts, 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 dyads 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial (sites are randomized to the intervention or control condition)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: H2GO!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 (SSB) consumption and increase in water consumption being the primary behavioral targets. |
| 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. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H2GO!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. | Behavioural | Intervention |
Primary outcome
Child Body Mass Index (BMI) z Scores
Time frame: baseline, 12 months
Trained staff obtained child participants' height (inches) and weight (pounds) using standardized equipment and calculated using the Centers for Disease Control (CDC) 2000 sex- and age-specific growth charts. A BMI z-score of 0 represents the age- and sex-specific population mean, with positive values indicating BMI above the reference population mean and negative values indicating BMI below the reference population mean. Lower BMI z-scores represent a more favorable outcome in this childhood obesity prevention trial, while higher BMI z-scores indicate relatively greater adiposity
2 secondary outcomes
Sugar-sweetened Beverage Intake
Time frame: Baseline, 12 months
Water Intake
Time frame: Baseline,12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42853568Wang ML, Alatorre S, Schwarz AG, Weinberg J, Sprague Martinez L, Aldworth J, Kadel R, Rosal MC, Lemon SC. A Community-Based Behavioral Intervention and Body Mass Index in School-Aged Children: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638188. doi: 10.1001/jamanetworkopen.2026.38188.
- Derived from this study: PubMed 34525990Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Wang, ScD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H2GO! in people with Childhood Obesity, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Body Mass Index (BMI) z Scores (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265794, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.