NCT07789405

Brief Summary

The purpose of this study is to evaluate whether a digital intervention can improve body image and psychological well-being among adolescent boys who attend fitness clubs. Fitness club environments and social media often promote appearance ideals related to muscularity and leanness, which may contribute to body appearance pressure, body dissatisfaction, and psychological distress among boys. In this cluster-randomized controlled trial, approximately 260 boys aged 15 to 18 years will be recruited from fitness clubs in Oslo, Norway. Participants from fitness clubs assigned to the intervention group will receive access to a 12-week website-based program consisting of four interactive modules focusing on body image, psychological well-being, critical social media literacy, and attitudes toward food and sports supplements. Participants in the control group will continue their usual activities. The study will examine whether the intervention reduces internalization of appearance ideals and body appearance pressure and improves body appreciation, health-related quality of life, psychological well-being, social media-related behaviors, and attitudes toward food and sports supplements. Outcomes will be assessed at baseline, immediately after the intervention, and at a 6-month follow-up.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2028

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 18, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Adolescent BoysFitness ClubsBody ImageBody AppreciationBody Image PressureSocial Media LiteracyPsychological Well-BeingDigital InterventionCluster Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Internalization

    Internalization of appearance ideals (Sociocultural Attitudes Towards Appearance Questionnaire-4 \[SATAQ-4\]). This outcome assesses the extent to which participants adopt societal appearance ideals related to muscularity, leanness, and low body fat as personal standards for evaluating their own appearance. Internalization is measured using the relevant SATAQ-4 subscales. Items are rated on a 5-point Likert scale ranging from 1 (definitely disagree) to 5 (definitely agree), with higher scores indicating greater internalization of societal appearance ideals. The outcome will be assessed at baseline, post-intervention (12 weeks), and 6-month follow-up.

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • Body appearance pressure

    Body appearance pressure measured using the Sociocultural Attitudes Towards Appearance Questionnaire-4 Revised (SATAQ-4R). Scores range from 1 to 5, with higher scores indicating greater perceived appearance-related pressure from media and sociocultural influences.

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

Secondary Outcomes (6)

  • Body appreciation

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • Social Media use

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • General health-related quality of life.

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • Psychological distress

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • Food-related attitudes.

    Baseline, post-intervention (12 weeks), and 6-month follow-up.

  • +1 more secondary outcomes

Study Arms (2)

Digital intervention

EXPERIMENTAL

Participants assigned to the intervention arm will receive access to a website, a 12-week digital intervention designed to promote positive body image and psychological well-being among adolescent male fitness club members. The intervention consists of four interactive modules released every three weeks and addresses body image, psychological well-being, critical social media literacy, and attitudes toward food and sports supplements. Modules include brief narrative-based content, quizzes, personalized feedback, and reflection exercises. Total engagement time is approximately 75 minutes across the 12-week intervention period.

Other: Website

Control group

NO INTERVENTION

Participants assigned to the control condition will continue their regular exercise and daily activities without receiving the Strong Minds intervention during the 12-week trial period. Outcome assessments will be conducted at the same time points as in the intervention group (baseline, post-intervention, and 6-month follow-up). Access to the digital intervention will be provided after completion of the randomized controlled trial.

Interventions

WebsiteOTHER

Participants assigned to the intervention arm will receive access to the Strong Minds website, a 12-week digital intervention designed to promote positive body image and psychological well-being among adolescent male fitness club members. The intervention consists of four interactive modules released every three weeks and addresses body image, psychological well-being, critical social media literacy, and attitudes toward food and sports supplements. Modules include brief narrative-based content, quizzes, personalized feedback, and reflection exercises. Total engagement time is approximately 75 minutes across the 12-week intervention period.

Digital intervention

Eligibility Criteria

Age15 Years - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis study is open to cisgender boys. Participants must identify as male and have been assigned male sex at birth.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cisgender boy
  • Aged 15 to 18 years
  • Current member of a fitness club
  • Attends the fitness club at least once per week
  • Able to read and understand Norwegian
  • Provides informed consent (parental/guardian consent required for participants younger than 16 years)

You may not qualify if:

  • Not able to provide informed consent
  • Previously enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label cluster-randomized controlled trial. Participants, investigators, and fitness club staff will be aware of group allocation because participants assigned to the intervention group will receive access to a website-based intervention, while participants in the control group will continue their usual activities. Outcomes will be collected through self-reported online questionnaires and analyzed according to the pre-specified statistical analysis plan.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 27, 2026

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Individual participant data that have been de-identified, including demographic characteristics, outcome measures, and questionnaire data underlying the published results, will be made available to qualified researchers upon reasonable request following publication of the main study findings. Data sharing will be conducted in accordance with applicable ethical approvals, data protection regulations, and FAIR data principles.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months after publication of the primary study results with no predefined end date.
Access Criteria
Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Researchers must submit a methodologically sound research proposal and may be required to sign a data access agreement. Requests will be reviewed by the study investigators to ensure compliance with ethical approvals, applicable data protection regulations, and institutional policies. Data will be shared only for research purposes consistent with the objectives of the original study.