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

Running, not enrolling · Not applicable

Conditions studied: Obesity, Adolescent

In brief

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).

Key facts

Study ID: NCT04213014
Run by: Michigan State University
People needed: 935
Starts: 2020-09-26
Expected to finish: 2026-08-31
Last updated by the study team: 2026-06-22

Who can join

Age: 10 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Adolescent inclusion criteria are:
5th-8th grade boys and girls (ages 10-14)
available and willing to participate in GOAL, including the school club conducted after school 2 days/week for 13 weeks (not during 3 weeks of school breaks)
available for follow up (9 months after intervention ends)
agree to random assignment
able to read, understand, and speak English or have an interpreter
able to identify one parent/guardian who is willing and able to serve as a support person and complete study activities
Adolescent exclusion criteria are:
mental or physical health condition precluding safe MVPA
taking medications that alter appetite, weight, or growth.
Parent/guardian inclusion criteria are:
have male or female student in 5th-8th grade
≥18 yrs. of age
available and willing to participate in GOAL
able to read, understand, and speak English or have an interpreter
have Internet access and device for accessing website (e.g., mobile phone ["smart" phone], tablet, computer) and a cellphone which can receive text messages.
mentally and physically able to serve as a support person.
Parent/guardian exclusion criteria are:
mental or physical health condition precluding engagement in safe MVPA and healthy meal preparation with adolescent
not interested in using a private social networking website, similar in design to Facebook, to respond to challenges
not interested in learning to post.

Where it is running

University of Michigan — Ann Arbor, Michigan, United States
Michigan State University — East Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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