H2GO! Program for Childhood Obesity

Overseen By Selenne Salatorre, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Medical condition limiting behavior change

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program can help children reduce sugary drink consumption to address childhood obesity. Participating families will either join a six-week empowerment program called H2GO! at select Boys and Girls Clubs or continue with the usual club activities. The program includes group sessions that focus on improving knowledge and habits related to drinking fewer sugary beverages and more water. Families who are current members of a participating Boys and Girls Club and have children aged 9-12 may be well-suited for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to research that could promote healthier lifestyle choices for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the H2GO! program is safe for children?

Research shows that the H2GO! program is a community effort to encourage young people to drink less sugary drinks and more water. Although specific safety data for this program is unavailable, it resembles other programs like Go4Fun®, which have proven safe and well-received in community settings.

This program does not test a new drug or medical device, so it does not fall under typical clinical trial phases. Instead, it focuses on changing habits and educating participants, usually involving minimal risk. Participants attend group sessions led by trained staff, where they learn to make healthier choices. This setup is generally considered safe for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the H2GO! Program for childhood obesity because it focuses on changing daily habits in a supportive community setting. Unlike standard treatments that often emphasize diet and exercise broadly, H2GO! specifically targets reducing sugar-sweetened beverages and increasing water intake through engaging, twice-weekly sessions. This program not only aims to change behaviors but also equips children and parents with the knowledge and skills needed to make healthier choices independently, offering a fresh approach to tackling childhood obesity.

What evidence suggests that the H2GO! program is effective for reducing childhood obesity?

Research has shown that reducing sugary drink consumption can help tackle childhood obesity. The H2GO! program is being tested in this trial as an intervention to decrease the amount of sugary drinks children consume. This reduction is linked to a lower body mass index (BMI), a measure of body fat based on height and weight. Early results from similar programs suggest that attending these sessions might improve children's BMI. The goal is to teach kids to choose healthier drinks, like water, instead of sugary ones. ^{2 3 5 6 7}

Who Is on the Research Team?

Monica Wang, ScD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for children aged 9-12 who are members at a Boys and Girls Club study site, can communicate in English, and have parental permission to participate. It aims to tackle childhood obesity by focusing on reducing sugar-sweetened beverage intake.

Inclusion Criteria

You are currently participating in another study at a BGC site.

I am a child participating in this study.

You can speak and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

6-week community-based behavioral program consisting of 12 group-based weekly sessions targeting sugar-sweetened beverage consumption and water consumption

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in BMI, sugar-sweetened beverage intake, water intake, and youth empowerment

12 months

Data collection at baseline, 2 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• H2GO!

Trial Overview

The H2GO! program being tested is a youth empowerment intervention that includes health education and activities over six weeks. The goal is to see if it affects the BMI of kids by changing their drink choices, with 450 parent-child pairs participating across 10 sites.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Comparison Active Control 1 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 Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Massachusetts Alliance of Boys and Girls Clubs

Collaborator

Trials

1

Recruited

820+

Published Research Related to This Trial

In a study of 3090 overweight and obese children participating in the Go4Fun program, attending at least five sessions led to significant improvements in BMI z-score, fruit and vegetable intake, and physical activity levels.

Children whose mothers had lower educational qualifications showed less improvement in BMI and vegetable intake, but those attending seven or more sessions had better outcomes, highlighting the importance of both session attendance and maternal education in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose response relationship between program attendance and children's outcomes in a community based weight management program for children and their families. Khanal, S., Choi, L., Innes-Hughes, C., et al.[2020]

The Let's Go! 5-2-1-0 pediatric obesity intervention program was implemented in a pilot study involving 8 classrooms of second- and third-grade children, but it did not lead to significant improvements in healthy habits, BMI, or physical activity compared to a control group.

The study highlighted the feasibility of the intervention, but the lack of significant results may be attributed to the small sample size and potential external factors influencing children's habits, suggesting that future research should involve larger groups and more comprehensive assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elementary School-Based Obesity Intervention Using an Educational Curriculum. Lynch, BA., Gentile, N., Maxson, J., et al.[2022]

School-based interventions can lead to long-term positive health behavior changes in children, as they spend a significant amount of time in school, although their impact on weight measures is less clear due to common limitations.

Family-based interventions are effective in influencing children's behaviors, but issues like selection bias and high dropout rates can affect the reliability of their results; thus, a multidisciplinary approach that includes both school and family involvement is recommended for managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. Kelishadi, R., Azizi-Soleiman, F.[2022]

In a study of 2977 American Indian children and adolescents, higher body mass index (BMI) percentiles were linked to increased blood pressure, higher fasting plasma glucose, and unfavorable cholesterol levels, indicating a higher cardiometabolic risk.

Longitudinal analysis showed that as BMI percentiles increased over time, there were corresponding increases in fasting glucose, 2-hour glucose, and triglycerides, along with a decrease in HDL cholesterol, highlighting the importance of monitoring BMI for health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk profile based on body mass index in American Indian children and adolescents. Wheelock, KM., Fufaa, GD., Nelson, RG., et al.[2018]

A systematic review of 22 studies on weight loss camps for obese children showed that these immersion programs resulted in significantly greater weight loss compared to standard outpatient treatments, with an average of 191% greater reductions in percent-overweight immediately after treatment.

Programs that included cognitive-behavioral therapy (CBT) demonstrated even more impressive results, with a 30% reduction in percent-overweight at follow-up, compared to just 9% for programs without CBT, suggesting that the combination of structured environment and behavioral support is highly effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersion treatment of childhood and adolescent obesity: the first review of a promising intervention. Kelly, KP., Kirschenbaum, DS.[2022]

Citations

1.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-11660-5

A youth empowerment intervention to prevent childhood obesity

This paper describes the design and methods of a cluster randomized trial of H 2 GO!, a youth empowerment intervention to prevent childhood obesity.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04265794

A Cluster Randomized Trial of the H2GO! Program

The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth.

3.

withpower.com

withpower.com/trial/phase-pediatric-obesity-9-2020-5ca10

H2GO! Program for Childhood Obesity · Info for Participants

In a study of 3090 overweight and obese children participating in the Go4Fun program, attending at least five sessions led to significant improvements in BMI z- ...

4.

grantome.com

grantome.com/grant/NIH/R01-DK120713-02

Preventing Childhood Obesity Through Youth Empowerment

Building on our successful pilot study of H2GO!, we are now positioned to test the efficacy of the H2GO! intervention in collaboration with the BGC network in ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02890056

A Community-based Study to Target Childhood Obesity

The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8441230/

A youth empowerment intervention to prevent childhood ...

This paper describes the design and methods of a cluster randomized trial of H 2 GO!, a youth empowerment intervention to prevent childhood obesity.

7.

reporter.nih.gov

reporter.nih.gov/search/sWWc-6HtI0mMkXpNp3i30g/project-details/9884463

Preventing Childhood Obesity Through Youth ... - NIH RePORTER

Project Summary/Abstract 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 ...