What side effects are associated with this type of intervention?

Behavioral interventions for obesity, such as those focusing on increasing motivation, self-efficacy, and social support, generally have minimal physical side effects. However, participants may experience psychological challenges such as frustration or decreased motivation if progress is slow. Additionally, there can be social and logistical barriers, such as difficulty maintaining lifestyle changes due to lack of support or time constraints. Overall, these interventions are considered safe and are primarily associated with positive outcomes like improved physical fitness and mental well-being.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, often as adjuncts to lifestyle interventions such as diet and exercise. Notable examples include the combination of bupropion-naltrexone, which leverages bupropion's ability to stimulate hypothalamic neurons and naltrexone's opioid-receptor antagonism to reduce food intake. Another approved drug is liraglutide, a GLP-1 receptor agonist that has shown efficacy in weight management. These pharmacological treatments can complement behavioral interventions like those in the GOAL trial, which aim to increase motivation, self-efficacy, and social support for healthier lifestyle choices.

What other types of research exist?

Promising alternatives to the GOAL intervention for obesity patients include: 1) Digital self-help interventions, such as internet-based guided self-help programs and smartphone applications like Noom Monitor, which have shown efficacy in managing eating behaviors and promoting weight loss. 2) Compulsive Exercise Activity Therapy (LEAP), which addresses compulsive exercise behaviors in eating disorders and can be adapted for obesity treatment. 3) Motivational interviewing techniques, which enhance motivation and willingness to change by exploring patients' beliefs and goals. 4) Family-based and individual therapy approaches that involve family members in the treatment process to provide social support and address behavioral changes comprehensively.

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GOAL Program for Childhood Obesity (GOAL Trial)

N/A

Waitlist Available

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

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

Must have

5th-8th grade boys and girls (ages 10-14)

≥18 yrs. of age

Must not have

taking medications that alter appetite, weight, or growth.

mental or physical health condition precluding safe MVPA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (0 months) and immediately post-intervention (after 4 months)

Awards & highlights

Summary

This trial tests the GOAL program, which helps underserved adolescents in Michigan become more active and eat healthier. The program includes after-school clubs, parent meetings, and a social networking site. It works by boosting kids' motivation and confidence while providing social support from parents and peers.

Who is the study for?

The GOAL trial is for boys and girls in 5th-8th grade (ages 10-14) who can understand English, with parents willing to participate. It's open to all interested students, not just those with high BMI, to avoid stigma. Parents need internet access and a device capable of receiving text messages.

What is being tested?

GOAL aims to increase physical activity and healthy eating among young adolescents through after-school clubs, parent meetings, and a social networking site for parents. The trial will compare the effects of this intervention against usual school activities on cardiovascular health and quality of life.

What are the potential side effects?

Since GOAL promotes exercise and nutrition without medical or pharmaceutical interventions, side effects are minimal but may include typical risks associated with new physical activities such as muscle soreness or injury.

Eligibility Criteria

Inclusion Criteria

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

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I am a boy or girl in 5th to 8th grade, aged 10-14.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication that affects my appetite, weight, or growth.

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I have a health condition that makes it unsafe for me to do moderate to vigorous physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 months) and immediately post-intervention (after 4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (0 months) and immediately post-intervention (after 4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 months) and immediately post-intervention (after 4 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 from Baseline Percent (%) Body Fat (adolescents) to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U])

Secondary study objectives

Change from Baseline Cardiovascular (CV) Fitness (adolescents) to 4 months (immediate post-intervention)

Change in Baseline Social Support for Healthy Eating (adolescents) from baseline to 4 months (immediate post-intervention)

Change in Body Mass Index (BMI) and Overweight/Obesity Percentage from baseline to 4 months (post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U]).

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Guys/Girls Opt for Activities for Life Intervention (GOAL)Experimental Treatment1 Intervention

Receives the 4 month (16-wk) GOAL intervention, which has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 wks due to no club during 3 school break wks) for boys and girls to engage in physical activity and healthy eating and cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school with parents and adolescents \[Zoom option if needed\]; 2nd and 3rd meetings delivered virtually for parents): to empower parents to assist adolescents with physical activity and healthy eating and cooking; and (3) GOAL social networking website: private website for parents to share with each other how they helped their adolescent increase physical activity and diet quality each week.

Group II: ControlActive Control1 Intervention

Received usual school activities.

0 / 4Eligibility 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 obesity, such as those studied in the GOAL trial, focus on increasing physical activity, promoting healthy eating, and enhancing motivation, self-efficacy, and social support. These mechanisms work by encouraging sustainable lifestyle changes that lead to weight loss and improved health outcomes. Increased physical activity helps burn calories and improve cardiovascular fitness, while healthy eating reduces caloric intake and improves nutrient quality. Enhancing motivation and self-efficacy empowers patients to adhere to these changes, and social support provides encouragement and accountability. These interventions are crucial for obesity patients as they address the root behavioral causes of obesity and promote long-term health improvements.