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

NCT04213014 | Active Not Recruiting DMC

• 3 other identifiers: STUDY00002538R61HL144896R33HL144896
• Study Type: interventional
• Target: 935
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

Obesity, Adolescent

Keywords

exercise; nutrition; parent; adolescent; overweight; percent body fat; cardiorespiratory fitness; body mass index; obesity

Outcome Measures

Primary Outcomes (1)

• 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])

  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 available immediately from the RJL software program. If the 2 measurements differ by \>1%, a 3rd measurement must be taken.

  baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)

Secondary Outcomes (15)

• 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]).

  baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)

• Change from Baseline Cardiovascular (CV) Fitness (adolescents) to 4 months (immediate post-intervention)

  baseline (0 months) and immediately post-intervention (after 4 months)

• Change in Minutes of Moderate-to-Vigorous Physical Activity (MVPA; adolescents) from baseline to 4 months (immediate post-intervention)

  baseline (0 months) and immediately post-intervention (after 4 months)

• Change in Quality of Life (adolescents) from baseline to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U]).

  baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)

• Change in Diet Quality (e.g., healthy eating index, servings of fruit and vegetables, sweetened beverage consumption; adolescents) from baseline to 4 months (immediate post-intervention)

  baseline (0 months) and immediately post-intervention (after 4 months)

Study Arms (2)

Guys/Girls Opt for Activities for Life Intervention (GOAL)

EXPERIMENTAL

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.

Behavioral: Guys/Girls Opt for Activities for Life (GOAL)

Control

NO INTERVENTION

Received usual school activities.

Interventions

Guys/Girls Opt for Activities for Life (GOAL) BEHAVIORAL

The 4 month (16-wk) GOAL intervention has 3 components: (1) After-school GOAL Club: 26 events (2 days/week; 120 min/event/day; 13 weeks due to no club during 3 school break weeks) 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 for parents and adolescents \[Zoom option if needed\]; 2nd and 3rd meetings delivered virtually and asynchronously 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.

Guys/Girls Opt for Activities for Life Intervention (GOAL)

Eligibility Criteria

• Age: 10 Years - 14 Years
• Gender Eligibility Details: In each school, boys and girls (on average, at least 63 adolescents per school; approximately 1/2 boys and 1/2 girls) and one parent/guardian per adolescent (male or female who is willing to serve as a support person) will be included.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• th-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

You may not qualify if:

• mental or physical health condition precluding safe MVPA
• taking medications that alter appetite, weight, or growth.
• 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.
• 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.

Sponsors & Collaborators

• Michigan State University: lead
• University of Michigan: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (2)

• Robbins LB, Ling J, Pfeiffer KA, Kerver JM, Resnicow K, McCaffery H, Hilliard A, Hobbs L, Donald S, Kaciroti N. Intervention to increase physical activity and healthy eating among under-represented adolescents: GOAL trial protocol. BMJ Open. 2024 Jan 3;14(1):e080437. doi: 10.1136/bmjopen-2023-080437.

  PMID: 38171630 BACKGROUND

• Fraczek N, Robbins LB, Varpaei HA, Arcoleo K, Ling J. Relationships of motivation, self-efficacy and social support with healthy eating behaviours among adolescents. BMJ Nutr Prev Health. 2025 Nov 28;8(2):e001369. doi: 10.1136/bmjnph-2025-001369. eCollection 2025.

  PMID: 41502578 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity; Overweight; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After baseline data collection, adolescents and parents at each school will be told whether they will receive the GOAL intervention or not. We see no way to blind participants as to which group they are in. Adolescents, parents, principals, school staff, interventionists, and process evaluators will not be told about study aims and hypotheses. Process evaluators (trained by Co-I Pfeiffer) will be independent and not involved in other study areas. Data collectors and biostatistician will not be aware of any adolescent's or parent's (the dyad's) randomization status. Data collectors and interventionists are in separate teams and have separate training and meetings.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The 16-wk intervention has 3 components. 1. After-School GOAL Club for moderate-to-vigorous physical activity (MVPA) and healthy eating/cooking skill-building (13 weeks; 120 min/event \[N=26\]; 2 days/week; not offered for 3 weeks of holiday, winter, spring school breaks). 2. Three Parent Meetings to empower participants regarding physical activity (PA) and healthy eating and cooking (90 min/meeting \[N=3\]; Weeks 1, 6, \& 11). 3. GOAL Social Networking Website for Parents to help their adolescents with MVPA and healthy eating and cooking (parents will complete weekly healthy habit-forming tasks; Weeks 1-16). The website will offer information, encouragement, and behavioral strategies to help parents increase their adolescents' PA and healthy eating.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 30, 2019
• Study Start: September 26, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data sets will be submitted to the study NHLBI Program Official no later than 3 years after the end of the final follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• Access Criteria: We plan to adhere to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies and Guidelines for NHLBI Data Set Preparation. Documentation for data sets will be clear to enable other researchers not familiar with a data set to use it in the future. A summary documentation file will be created to provide a complete overview of the data and description of their use for researchers who are not familiar with the data set. Data will only be made available under terms consistent with the informed consent provided by individual participants, and as approved by the Michigan State University (MSU) Human Research Protection Program/Institutional Review Board (IRB) and any local, state, and federal laws and regulations. In addition, de-identified electronic data will be archived in the MSU College of Nursing (CON) for use by faculty, students, or other researchers in the future. Interested users will be asked to contact the PI and sign a data sharing agreement.

Locations

US (2)