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Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating

Study acronym: GOAL
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Apr 30, 2026 → Apr 30, 2027
See other at-risk trials from Michigan State University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Apr 30, 2026 to Apr 30, 2027 Show 7 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Interventions: Guys/Girls Opt for Activities for Life (GOAL) (Behavioral) to Guys/Girls Opt for Activities for Life (GOAL) (Behavioral)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 15 of 15 entries
    • Study description revised
    • Publications: details revised at 3 of 3 entries
  2. Minor Re-verified, no change to tracked fieldsv13
  3. Minor Publications: details revised at 2 of 3 entriesv12
  4. Notable Enrollment target: 559 to 935
    • Secondary endpoints: details revised at 1 of 15 entries
    • Study description expanded, about 83 words
    • Publications: details revised at 1 of 3 entries
    v11
  5. Minor Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Phase: Phase 3 to Not applicablev9 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1764 to confirmed 559
    • Secondary endpoints: details revised at 1 of 15 entries
    • Site details revised at 2 of 2 sites
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 3 words
  2. Notable Trial status: Active, Not Recruiting to Recruitingv8 Show 4 more changesShow less
    • Enrollment target: 1760 to 1764
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 55 words
    • Site details revised at 2 of 2 sites
  3. Notable Primary completion date: Apr 30, 2025 to Apr 30, 2026v7 Show 4 more changesShow less
    • Study completion date: Jul 31, 2025 to Aug 31, 2026
    • Eligibility criteria shortened, about 78 words
    • Secondary endpoints: 16 to 15
    • Study description expanded, about 366 words
  4. Notable Trial status: Suspended to Active, Not Recruitingv6 Show 6 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Feb 28, 2025 to Apr 30, 2025
    • Study completion date: Jun 30, 2025 to Jul 31, 2025
    • Secondary endpoints: details revised at 5 of 16 entries
    • Study description expanded, about 54 words
    • Eligibility criteria expanded, about 5 words
  5. Notable Primary completion date: Feb 28, 2024 to Feb 28, 2025v5 Show 4 more changesShow less
    • Sponsor's reason: Recruitment halted due to COVID19 to Recruitment halted due to COVID19; Study is in no-cost extension due to COVID.
    • Study completion date: Aug 31, 2024 to Jun 30, 2025
    • Eligibility criteria revised
    • Study description revised
  6. Minor Start date changed from estimate of Sep 30, 2020 to Sep 26, 2020v4
  7. Stopped Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Recruitment halted due to COVID19
    • Start date: May 30, 2020 to Sep 30, 2020
    • Site contact updated
    v3
  8. Notable Start date: Apr 30, 2020 to May 30, 2020
    • Site contact updated
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 are including all interested students and not only those who have a high BMI (e.g., BMI z-score ≥0 \[≥50th percentile\]), in order to avoid social stigma(s) discouraging adolescents from participating. Adolescents in each of 14 schools total will be randomly assigned to the intervention or control (usual school activities) condition. The plan is to include at least n=33 intervention and n=30 control adolescents in each school every year for 3 years of the R33 Phase. On average, we will include at least 63 adolescents per school (at least 31-32 boys and 31-32 girls) and one parent per adolescent will be enrolled, bringing our total sample size to at least 882 dyads total (882 adolescents and one parent per adolescent).
Trial Details
NCT Number NCT04213014
Lead Sponsor Michigan State University
Collaborators: University of Michigan, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Obesity, Adolescent
Related terms Motor Activity, Obesity, Overweight, Pediatric Obesity
Enrollment 935 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov