← Back to Search

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
No Placebo-Only Group

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
Select...
I am a boy or girl in 5th to 8th grade, aged 10-14.
Select...
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.
Select...
I have a health condition that makes it unsafe for me to do moderate to vigorous physical activity.

Timeline

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

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: 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.

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.

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
197 Previous Clinical Trials
684,626 Total Patients Enrolled
10 Trials studying Obesity
5,135 Patients Enrolled for Obesity
University of MichiganOTHER
1,844 Previous Clinical Trials
6,429,198 Total Patients Enrolled
36 Trials studying Obesity
10,052 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,916 Previous Clinical Trials
47,757,636 Total Patients Enrolled
255 Trials studying Obesity
211,561 Patients Enrolled for Obesity

Media Library

Guys/Girls Opt for Activities for Life (GOAL) Clinical Trial Eligibility Overview. Trial Name: NCT04213014 — N/A
Obesity Research Study Groups: Control, Guys/Girls Opt for Activities for Life Intervention (GOAL)
Obesity Clinical Trial 2023: Guys/Girls Opt for Activities for Life (GOAL) Highlights & Side Effects. Trial Name: NCT04213014 — N/A
Guys/Girls Opt for Activities for Life (GOAL) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04213014 — N/A
~142 spots leftby Apr 2026