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NCT04213014 · ClinicalTrials.gov registry record · NA
Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating
A NA study of Obesity, Adolescent, sponsored by Michigan State University.
- Active
- Registry status
- NA
- Development phase
- 935
- Enrollment target
- 2
- Study locations
NCT04213014: Active NA study of Obesity, Adolescent, sponsored by Michigan State University.
NCT04213014 is a NA study of Obesity, Adolescent that is active but no longer recruiting, run by Michigan State University. The registered enrollment target is 935 participants, above the 88-participant average among 6 other Obesity, Adolescent trials with a reported enrollment target (963% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04213014, a NA study of Obesity, Adolescent, is active but no longer recruiting, sponsored by Michigan State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 935 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this 2-phase trial (R61/R33), we propose Guys/Girls Opt for Activities for Life (GOAL). Guided by Self-Determination Theory and the Information-Motivation-Behavioral Skills Model, GOAL will target the school and home environment to increase young adolescents' physical activity (PA) and healthy eating by increasing important factors at the individual-level: motivation and self-efficacy; and socioenvironmental-level: social support. The 4-month (16-wk) GOAL intervention has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 weeks due to no club during 3 school break weeks) for boys and girls to engage in PA and healthy eating/cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school, which is also conducted synchronously via Zoom to increase convenience for parents who are not able to meet in-person at the school for various reasons; 2nd and 3rd meetings video-recorded and delivered asynchronously to accommodate and meet the needs of busy parents who have varying schedules due to work, home, and other responsibilities): to empower parents to assist adolescents with PA and healthy eating/cooking; and (3) GOAL social networking website: private website (already developed) for parents to learn about healthy eating and PA, network with other parents, and share with each other about how they helped their adolescent(s) increase PA and diet quality each week. The purpose of this individual randomized controlled trial (unit of assignment is adolescent) is to evaluate the effect of GOAL on decreasing cardiovascular disease risk factors (high percent body fat, overweight/obesity, low cardiovascular fitness), improving quality of life; and increasing motivation, self-efficacy, and social support to increase moderate-to-vigorous PA and diet quality among adolescents (5th-8th grade) throughout the state of Michigan. All interested adolescents who meet eligibility criteria and have parental consent will be included. We
Primary Outcome
Bioelectric impedance analysis (BIA) will be used to estimate % body fat. The manufacturer's protocol will be followed (RJL Quantum \[IV\] BIA Systems, Clinton Township, MI). Testing will be conducted behind a privacy screen by 2 data collectors. Boys and girls will void before testing. Measures will be taken with electrodes: 1 placed on the hand, wrist, foot, and ankle; all on right side of body. Percent (%) body fat will be measured to nearest .1%. Two measurements will be taken. Results are a
Conditions Studied
Interventions
- BEHAVIORAL Guys/Girls Opt for Activities for Life (GOAL)
Study Locations (2)
Michigan
- University of Michigan - Ann Arbor
- Michigan State University - East Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 935 participants |
| Start Date | 2020-09-26 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What the registry record for NCT04213014 still lists
NCT04213014 is an interventional study that assigns participants to a tested intervention. The registered 935 participants enrollment target is mid-sized for trials with a published cap, above the 88-participant average among 6 other Obesity, Adolescent trials with a reported enrollment target (963% higher).
The record links to 1 condition, with Obesity, Adolescent appearing as the primary indexed condition, and to 1 intervention - of which Guys/Girls Opt for Activities for Life (GOAL) is the first listed.
NCT04213014 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04213014 about?
NCT04213014 is a clinical study titled "Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating". In this 2-phase trial (R61/R33), we propose Guys/Girls Opt for Activities for Life (GOAL). Guided by Self-Determination Theory and the Information-Motivation-Behavioral Skills Model, GOAL will target the school and home environment to increase young adolescents' physical activity (PA) and healthy ea...
What is the current status of trial NCT04213014?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 935 participants. The study started on 2020-09-26. Estimated completion is 2026-08-31.
What conditions does trial NCT04213014 study?
This clinical trial studies the following conditions: Obesity, Adolescent.
What interventions are being tested in trial NCT04213014?
The interventions under investigation include: Guys/Girls Opt for Activities for Life (GOAL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04213014?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04213014 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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