What is the mechanism of action of this treatment?

Behavioral interventions for childhood obesity, such as the Youth Empowerment Intervention, primarily focus on modifying dietary habits and increasing physical activity. These programs often include educational sessions that teach children and their parents about the health risks associated with high sugar intake and the benefits of healthier alternatives like water. By empowering youth to make healthier choices and engage in physical activities, these interventions aim to reduce overall caloric intake and increase energy expenditure, leading to a healthier body mass index (BMI). This approach is crucial for childhood obesity patients as it addresses the root causes of obesity, promotes long-term healthy habits, and can prevent the development of obesity-related health issues.

What side effects are associated with this type of intervention?

Behavioral modification strategies for childhood obesity, such as those targeting sugar-sweetened beverage consumption, are generally safe with minimal side effects. Potential side effects include temporary gastrointestinal discomfort from dietary changes, muscle soreness or minor injuries from increased physical activity, and emotional distress from psychological interventions. These side effects are typically mild and manageable with proper guidance and support.

What prior FDA approvals exist?

The FDA has approved several treatments for childhood obesity, primarily focusing on lifestyle and behavioral interventions. These interventions often include dietary changes, increased physical activity, and behavioral therapy aimed at reducing caloric intake and improving overall health. While there are medications approved for obesity in adults, such as orlistat and liraglutide, their use in children is more limited and typically considered when lifestyle interventions alone are insufficient. The Youth Empowerment Intervention, which targets sugar-sweetened beverage consumption through behavioral modification, aligns with these non-pharmacological approaches that emphasize sustainable lifestyle changes.

What other types of research exist?

Promising alternatives to the Youth Empowerment Intervention for childhood obesity include: 1) The DASH (Dietary Approaches to Stop Hypertension) diet, which has been shown to improve blood pressure and vascular health in youth. 2) Comprehensive family-based lifestyle interventions, such as those used in the TODAY study, which focus on diet and physical activity. 3) School-based programs like Kids SIP smartER, which aim to reduce sugar-sweetened beverage consumption through educational sessions. 4) Behavioral and nutritional treatments, such as those used in cystic fibrosis studies, which focus on improving energy intake and growth.

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Behavioral Intervention

H2GO! Program for Childhood Obesity

N/A

Recruiting

Led By Monica Wang, ScD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child participant

Ages 9-12 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational sessions rather than medication, there aren't typical medical side effects. However, participants may experience changes in lifestyle or behavior due to the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a child participant.

Select...

I am between 9 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in child body mass index (BMI) z score

Secondary study objectives

Change in sugar-sweetened beverage intake

Change in water intake

Other study objectives

Change in youth empowerment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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: ComparisonActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

H2GO!

2016

N/A

~210

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions for childhood obesity, such as the Youth Empowerment Intervention, primarily focus on modifying dietary habits and increasing physical activity. These programs often include educational sessions that teach children and their parents about the health risks associated with high sugar intake and the benefits of healthier alternatives like water. By empowering youth to make healthier choices and engage in physical activities, these interventions aim to reduce overall caloric intake and increase energy expenditure, leading to a healthier body mass index (BMI). This approach is crucial for childhood obesity patients as it addresses the root causes of obesity, promotes long-term healthy habits, and can prevent the development of obesity-related health issues.

Lifestyle interventions for youth who are overweight: a meta-analytic review.