NCT07702110

Brief 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. 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.

Trial Health

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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress9%
Jul 2026Apr 2027

First Submitted

Initial submission to the registry

July 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 8, 2026

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline to 6 months after randomization

Secondary Outcomes (1)

  • Change Behavior

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

Study Arms (2)

TTM Intervention Group

EXPERIMENTAL

Participants will receive an individualized, stage-matched behavioral counseling program targeting reduction and cessation of nonmedical anabolic-androgenic steroid use.

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.

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

Interventions

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.

Control GroupTTM Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ● 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

You may not qualify if:

  • ● 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fitness Center

Mosul, Nineveh Governorate, Iraq

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Raad kareem Faraj K Faraj, PhD

    University of Baghdad college of nursing

    STUDY CHAIR
  • Faraj, PhD

    University of Baghdad college of nursing

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nursing Instructor

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

July 8, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations