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

824 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help children reduce sugary drink consumption and prevent obesity. It focuses on low-income and ethnic minority kids, using activities that build confidence and critical thinking. The goal is to see if this approach can effectively lower obesity risk.

Will I have to stop taking my current medications?

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

Is the H2GO! Program for Childhood Obesity safe for children?

The available research does not provide specific safety data for the H2GO! Program for Childhood Obesity. However, similar community-based programs like Go4Fun® in Australia have been implemented without reported safety concerns, suggesting that such programs are generally safe for children. ^{1 2 3 4 5}

How is the H2GO! treatment for childhood obesity different from other treatments?

The H2GO! Program for childhood obesity is unique because it likely involves a community-based approach, focusing on prevention and treatment in diverse and low-socioeconomic communities, which is not always the focus of other treatments. This approach may include family, school, and clinic-based interventions tailored to these specific communities. ^{6 7 8 9 10}

What data supports the effectiveness of the H2GO! treatment for childhood obesity?

The immersion treatment programs for childhood obesity, which include controlled diet, activities, nutrition education, and behavior change therapy, have shown significant weight loss in children. These programs, especially those with cognitive-behavioral therapy, resulted in greater reductions in overweight percentages compared to standard outpatient treatments. ^{11 12 13 14 15}

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

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]

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]

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]

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]

Citations

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Immersion treatment of childhood and adolescent obesity: the first review of a promising intervention. [2022]

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Lifestyle modification and metformin as long-term treatment options for obese adolescents: study protocol. [2021]

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Promising results from an implemented treatment model for paediatric obesity. [2021]

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Under 5 Energize: Tracking Progress of a Preschool Nutrition and Physical Activity Programme with Regional Measures of Body Size and Dental Health at Age of Four Years. [2019]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Elementary School-Based Obesity Intervention Using an Educational Curriculum. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The GReat-Child™ Trial: A Quasi-Experimental Intervention on Whole Grains with Healthy Balanced Diet to Manage Childhood Obesity in Kuala Lumpur, Malaysia. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Process evaluation of an up-scaled community based child obesity treatment program: NSW Go4Fun®. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk profile based on body mass index in American Indian children and adolescents. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Systematic review of community-based childhood obesity prevention studies. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Assessing childhood obesity programs in low-socioeconomic and diverse communities. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Prevalence of overweight among Dutch primary school children living in JOGG and non-JOGG areas. [2022]