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NCT Number: NCT07702110

Anabolic-Androgenic Steroid Use Among Gym-Goers

This randomized controlled trial will evaluate the efficacy of a Transtheoretical Model (TTM)-based behavior-change intervention, delivered through stage-matched counseling sessions, on anabolic-androgenic steroid (AAS) use among gym-goers, compared with a control group receiving standard health education. Non-medical AAS use is a growing public health concern in gym and fitness settings and is associated with serious cardiovascular, endocrine, hepatic, and psychiatric harms. Participants will be randomly assigned to either a TTM-based intervention group or a control group. The intervention will tailor counseling content to each participant's stage of change (precontemplation, contemplation, preparation, action, or maintenance) regarding AAS use. The findings of this study will provide evidence on the effectiveness of stage-based behavioral counseling in reducing AAS use and progressing gym-goers toward safer, drug-free training practices.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Anabolic-androgenic steroid (AAS) use for aesthetic and performance-enhancing purposes has become an increasingly recognized problem among recreational and competitive gym-goers worldwide, with prevalence reported to be substantially higher in bodybuilding and fitness-center populations than in the general population. Non-medical AAS use is associated with cardiovascular disease, hepatotoxicity, endocrine disruption, and psychiatric sequelae including depression, aggression, and dependence. Despite this burden, few theory-driven behavioral interventions targeting AAS use in gym settings have been rigorously evaluated.

The Transtheoretical Model (TTM) proposes that behavior change unfolds through a sequence of stages (precontemplation, contemplation, preparation, action, and maintenance), and that interventions matched to an individual's current stage - using stage-specific processes of change, decisional balance, and self-efficacy strategies - are more effective than generic, one-size-fits-all education. TTM-based interventions have demonstrated efficacy in other health behaviors such as smoking cessation, weight management, and physical activity promotion, but their application to AAS use reduction among gym-goers remains limited.

This study will be conducted as a randomized controlled trial at fitness centers/gyms in Mosul city, Iraq. A total of [N, e.g., 120] adult gym-goers who report current or recent non-medical AAS use, or who are identified as being at risk of AAS use, will be enrolled and randomly assigned to one of two groups: a TTM-based intervention group or a control group. The intervention group will receive a structured, multi-session program of individualized counseling matched to participants' baseline stage of change, incorporating motivational interviewing techniques, decisional-balance exercises, and self-efficacy building strategies delivered over [e.g., 8 weeks]. The control group will receive standard printed health education materials on the risks of AAS use.

Data will be collected using validated self-report questionnaires assessing stage of change (e.g., a URICA-type or AAS-adapted staging algorithm), decisional balance (pros and cons of AAS use), self-efficacy to resist AAS use, and self-reported AAS use behavior (frequency, dose, and duration). Assessments will occur at baseline, immediately post-intervention, and at a follow-up time point. The study will compare the effect of the TTM-based intervention versus control on stage progression and AAS use behavior, and will examine the relationship between stage of change, decisional balance, self-efficacy, and actual reduction or cessation of AAS use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

● Adult gym members regularly attending the study fitness center(s)

● Male or female, aged 18 years or older

● Current or past-year non-medical use of anabolic-androgenic steroids, or identified as at risk of initiating use

● Willing to participate and provide informed consent

● Able to attend the assigned intervention sessions and complete study assessments

Exclusion criteria

● Nurses/participants who do not agree to participate in the study

● Use of AAS under current medical supervision/prescription for a diagnosed condition

● Not available during the study intervention or follow-up period

● Unable to attend the assigned intervention sessions

● Do not complete the required study assessments

● Participated in the pilot study

Treatment and study plan

TTM-Based Intervention for AAS Use Reduction A structured, multi-session counseling intervention grounded in the Transtheoretical Model. Content and techniques (e.g., consciousness raising, decisional

Behavioral

Participants receive a standard pamphlet/handout describing the physical and psychological risks of AAS use, consistent with routine health promotion practice at the study site.

Primary outcomes

  1. primary outcome meaure

    Time frame: Baseline, immediately after completion of the assigned intervention (post-test 1), and 8 weeks after completion of the intervention (post-test 2).]

    Stage of change for anabolic-androgenic steroid use Stage of change will be assessed using a validated, AAS-adapted staging algorithm based on the Transtheoretical Model (precontemplation, contemplation, preparation, action, maintenance). This outcome will evaluate participants' readiness to reduce or discontinue AAS use. Forward stage progression indicates a positive treatment effect.

  2. Change in Anabolic-Androgenic Steroid Use Behavior

    Time frame: Baseline to 6 months after randomization

    The primary outcome is the change in anabolic-androgenic steroid use behavior from baseline to the end of the intervention, assessed using a validated questionnaire.

Secondary outcomes

  1. Change Behavior

    Time frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test

    • Self-reported anabolic-androgenic steroid use behavior AAS use will be assessed using a self-report questionnaire capturing frequency, dose, and duration of use over the preceding period. This outcome will measure change in actual use behavior. Lower frequency/dose indicates reduced use.

    [Time Frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test 2).] 3. Decisional balance regarding anabolic-androgenic steroid use Decisional balance (perceived pros and cons of AAS use) will be assessed using the study questionnaire. This outcome will measure the shift in the balance of perceived benefits versus risks of AAS use. A decrease in perceived pros relative to cons indicates a positive treatment effect.

    [Time Frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test 2).] 4. Self-efficacy to resist anabolic-androgenic steroid u

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Yousif Ayed Y Ayed, Msc

CONTACT

[email protected]

9467518526800

Sponsors and collaborators

Lead sponsor

Alaa Yousif Ayed Ahmed

Other

Registry information

Official study title

Efficacy of a Transtheoretical Model-Based Intervention on Anabolic-Androgenic Steroid Use Among Gym-Goers: A Randomized Controlled Trial

Acronym: TTM - AAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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