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Набор скоро начнётся NCT07702110

Anabolic-Androgenic Steroid Use Among Gym-Goers

Без фазы С лечением Anabolic Androgenic Steroid Use Substance-Related Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Anabolic Androgenic Steroid Use, Substance-Related Disorders. Базовые параметры: 18 лет — 60 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ирак
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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
    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.

Первичные конечные точки

  • primary outcome meaure [Срок оценки: 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 [Срок оценки: Baseline to 6 months after randomization]
Вторичные конечные точки (1)
  • Change Behavior [Срок оценки: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test]

Критерии участия

Критерии включения

● 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

Критерии исключения

● 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Ирак · 1 центр
  • Fitness Center — Mosul

Идентификаторы

NCT: NCT07702110 · UoBaghdad_AYousif_2406p

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗