Your session is about to expire
← Back to Search
GOAL Program for Childhood Obesity (GOAL Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 months) and immediately post-intervention (after 4 months)
Awards & highlights
GOAL Trial Summary
This trial aims to increase physical activity and healthy eating in young adolescents by targeting motivation and self-efficacy at the individual level, and social support at the socioenvironmental level.
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.Check my eligibility
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.See study design
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.
GOAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a boy or girl in 5th to 8th grade, aged 10-14.
Select...
I am 18 years old or older.
GOAL Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreGOAL 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 during a prior wk.
Group II: ControlActive Control1 Intervention
Received usual school activities.
Find a Location
Who is running the clinical trial?
Michigan State UniversityLead Sponsor
185 Previous Clinical Trials
600,263 Total Patients Enrolled
10 Trials studying Obesity
5,135 Patients Enrolled for Obesity
University of MichiganOTHER
1,798 Previous Clinical Trials
6,376,374 Total Patients Enrolled
34 Trials studying Obesity
9,965 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,849,890 Total Patients Enrolled
252 Trials studying Obesity
206,056 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to join the GOAL study.I am taking medication that affects my appetite, weight, or growth.I am a student in 5th to 8th grade.I am mentally and physically capable of supporting someone.I am a boy or girl in 5th to 8th grade, aged 10-14.I am 18 years old or older.I am not interested in learning to post.I am an adolescent.I have a health condition that makes it unsafe for me to do moderate to vigorous physical activity.I am not an adolescent.I can join the GOAL program, including after-school clubs for 13 weeks.I am not interested in using a social network like Facebook for challenges.You have a mental or physical health condition that makes it difficult for you to participate in safe physical activities and prepare healthy meals with teenagers.
Research Study Groups:
This trial has the following groups:- Group 1: Guys/Girls Opt for Activities for Life Intervention (GOAL)
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does the GOAL program affect patients in the long run?
"The Guys/Girls Opt for Activities for Life Intervention (GOAL) program has received a Phase 3 designation. This suggests that while there is some efficacy data, the primary focus is on safety at this stage."
Answered by AI
Are people of an older age bracket still being considered for this experiment?
"This specific trial is for children aged 10-14, though there are a total of 144 clinical trials for minors and 26 for senior citizens."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger