- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07789405
Strong Minds: A Digital Intervention Targeting Body Image and Psychological Well-being Among Adolescent Male Fitness Club Members (Strong Minds)
Strong Minds: A Digital Intervention Targeting Body Image and Psychological Well-Being Among Adolescent Male Fitness Club Members
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The prevalence of body image concerns among adolescent boys has increased in recent years, accompanied by growing internalization of appearance ideals emphasizing muscularity, leanness, and physical performance. Fitness clubs represent an important social and exercise arena for adolescent boys and may contribute both positively and negatively to psychological well-being. While regular physical activity is associated with health benefits, fitness club environments often expose young males to appearance-focused norms, body comparisons, and social influences reinforced through social media and commercial fitness culture. These factors may increase body appearance pressure, body dissatisfaction, unhealthy attitudes toward food and supplements, and vulnerability to psychological distress. Despite the increasing participation of adolescent boys in fitness clubs, few evidence-based interventions have been developed for this population.
The Strong Minds study aims to evaluate the effectiveness of a digital intervention designed to promote positive body image and psychological well-being among adolescent male fitness club members. The intervention targets body image-related constructs, social media literacy, psychological well-being, and attitudes related to food and sports supplements. The study further seeks to examine mechanisms through which the intervention may influence outcomes, including body appreciation and social media-related processes.
The study will be conducted as a cluster-randomized controlled trial involving fitness clubs in Oslo, Norway. Fitness clubs will serve as the unit of randomization and will be allocated to either an intervention condition or a usual-routine control condition. Approximately 260 participants will be recruited. Data collection will occur at baseline, immediately following the intervention period, and six months after completion of the intervention.
Participants assigned to the intervention group will receive access to a website-based program delivered over 12 weeks. The intervention consists of four modules released at three-week intervals. To maximize engagement and feasibility, the intervention has been designed as a brief and interactive digital experience requiring approximately 75 minutes of total participation. Participants in the control group will continue their usual activities and will receive access to the intervention after study completion.
The intervention content has been developed using evidence-based approaches from body image prevention research, social media literacy interventions, positive psychology, embodiment theory, and sociocultural models of body image development. The website uses an interactive narrative format centered on realistic situations encountered by adolescent boys in fitness club settings. Through short episodes, quizzes, reflection exercises, and individualized feedback, participants are encouraged to critically evaluate appearance ideals, social media messages, body-related pressures, and health information encountered in everyday life. The intervention addresses four core themes: body image, psychological well-being, critical social media literacy, and attitudes toward food and sports supplements.
To enhance relevance, usability, and participant engagement, the intervention will be co-created with a Collaborative Competence Group consisting of young males with lived experience of body image concerns and/or disordered eating related to gym participation. User involvement will contribute to the development of content, design, language, functionality, and overall user experience.
Data will be collected through online questionnaires assessing body image-related constructs, body appreciation, health-related quality of life, psychological distress, social media use and appearance comparison, food-related attitudes, attitudes toward sports supplements, exercise habits, and demographic characteristics. Intervention adherence will be monitored through website analytics, including module completion and login frequency.
The study is funded by the Dam Foundation through ROS (Counselling and Support for Eating Disorders). Ethical approval procedures have been completed in accordance with Norwegian regulations, and all participants will provide informed consent before participation. The findings from the Strong Minds study will contribute to knowledge regarding scalable and accessible strategies for promoting positive body image and psychological well-being among adolescent boys in fitness club environments.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Does not meet one or more of the inclusion criteria
- Not able to provide informed consent
- Previously enrolled in the study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Digital intervention
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.
|
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.
|
|
Ei väliintuloa: Control group
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Internalization
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
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
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Body appreciation
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
The extent to which participants respect, accept, and value their bodies and maintain a positive body image despite societal appearance pressures.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
|
Social Media use
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Self-reported social media use, including platform(s) used, frequency of use per day, time spent on social media (hours/day), exposure to appearance-related content, appearance comparison, selfie posting, and motivations for use.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
|
General health-related quality of life.
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Self-reported health-related quality of life measured using the KIDSCREEN-10 questionnaire.
Higher scores indicate better quality of life and well-being.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
|
Psychological distress
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Psychological distress assessed using the Hopkins Symptom Checklist-10 (HSCL-10).
The HSCL-10 is a self-report measure of symptoms of anxiety and depression.
The total score is calculated as the mean of the 10 items, with response options ranging from 1 (not at all) to 4 (extremely).
Scores range from 1 to 4, with higher scores indicating greater psychological distress and a worse outcome.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
|
Food-related attitudes.
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Food-related attitudes and behaviors assessed using the Eating Attitudes Test-26 (EAT-26).
The EAT-26 is a self-report measure of attitudes, beliefs, and behaviors associated with eating-related concerns and disordered eating.
The total score ranges from 0 to 78, with higher scores indicating more problematic eating attitudes and behaviors and a worse outcome.
Assessments will be conducted at baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
|
Attitudes towards sports supplements
Aikaikkuna: Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Questions regarding anabolic steroids, testosterone preparations, growth hormone, ephedrine, and Selective Androgen Receptor Modulators (SARMS)) [GU33.1]based on Ungdata, an annual Norwegian data collection scheme.
|
Baseline, post-intervention (12 weeks), and 6-month follow-up.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Strong Minds
- #SDAM_FOR999270 (Muu apuraha/rahoitusnumero: The Dam Foundation)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .