Anabolic Androgenic Steroid UseTTM - AASNCT07702110
Anabolic-Androgenic Steroid Use Among Gym-Goers
A study testing 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 in people with Anabolic Androgenic Steroid Use and Substance-Related Disorders, run by Alaa Yousif Ayed Ahmed at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Anabolic Androgenic Steroid Use, Substance-Related Disorders
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 8 Jul 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ● 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
Who cannot join
- ● 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Fitness Center
Mosul, Nineveh Governorate
khalil I Ibrahim, Msc, 9467724201777, dr.raad@Conursing.Uobaghdad.edu.iq
Khalil I Ibrahim, Mcs, 9467724201777, dr.raad@Conursing.Uobaghdad.edu.iq
About this study
Official title: Efficacy of a Transtheoretical Model-Based Intervention on Anabolic-Androgenic Steroid Use Among Gym-Goers: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- 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
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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, decisionalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TTM Intervention Group | Experimental | Participants will receive an individualized, stage-matched behavioral counseling program targeting reduction and cessation of nonmedical anabolic-androgenic steroid use. Receives: Behavioral: 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 |
| Control Group | Active comparator | Participants will receive standard printed health education materials on the risks of anabolic-androgenic steroid use, without stage-matched counseling. Receives: Behavioral: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome meaure
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.
Measured: Baseline, immediately after completion of the assigned intervention (post-test 1), and 8 weeks after completion of the intervention (post-test 2).]
Change in Anabolic-Androgenic Steroid Use Behavior
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.
Measured: Baseline to 6 months after randomization
Secondary outcomes (1)
Change Behavior
- 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
Measured: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start8 Jul 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anabolic Androgenic Steroid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Yousif Ayed Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Yousif Ayed Ahmed, University of Baghdad
- Investigators
- Raad kareem Faraj K Faraj, PhD, Study chair, University of Baghdad college of nursingFaraj, PhD, Study director, University of Baghdad college of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702110
- Sponsor's protocol ID
- UoBaghdad_AYousif_2406p
- Acronym
- TTM - AAS
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a relatively small sample from specific gym/fitness-center settings, and data sharing may increase the risk of participant identification even after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Transtheoretical Model-Based Intervention on Anabolic-Androgenic Steroid Use Among Gym-Goers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07702110
- Acronym / sponsor ID
- TTM - AAS / UoBaghdad_AYousif_2406p
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alaa Yousif Ayed AhmedUniversity, hospital or other
- Study start
- 8 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTM Intervention Group | Experimental | Behavioral: 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, decisionalParticipants will receive an individualized, stage-matched behavioral counseling program targeting reduction and cessation of nonmedical anabolic-androgenic steroid use. |
| Control Group | Active comparator | Behavioral: 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, decisionalParticipants will receive standard printed health education materials on the risks of anabolic-androgenic steroid use, without stage-matched counseling. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ● 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
Key exclusion criteria (6 listed)
- ● 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, decisionalParticipants receive a standard pamphlet/handout describing the physical and psychological risks of AAS use, consistent with routine health promotion practice at the study site. | Behavioural | Control Group, TTM Intervention Group |
Primary outcome
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.
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.
1 secondary outcome
Change Behavior
Time frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a relatively small sample from specific gym/fitness-center settings, and data sharing may increase the risk of participant identification even after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raad kareem Faraj K Faraj, PhD study chair
University of Baghdad college of nursing
Faraj, PhD study director
University of Baghdad college of nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Anabolic Androgenic Steroid Use and Substance-Related Disorders, run by Alaa Yousif Ayed Ahmed at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Yousif Ayed Y Ayed, Msc (9467518526800, Alaa.Aayid2406p@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.