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临床试验/NCT05258409
NCT05258409已完成不适用

Evaluating Body Acceptance Programs for Young Men

Auburn University1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2022年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
1
主要终点
Muscularity Oriented Eating Test (MOET)

研究概览

简要总结

While eating disorders in males are often overlooked, up to 7 million men in the United States will experience an eating disorder in their lifetime. Critically, men are less likely to seek treatment for an eating disorder compared to women. Therefore, prevention programs that target male-specific eating disorder risk factors prior to the development of an eating or appearance-related disorder are crucial in reducing eating disorders in this population. Preliminary work by our group established the initial efficacy of a novel program, the Body Project: More than Muscles (MTM) compared to assessment-only control. This study will replicate and extend this research by comparing MTM to a time and attention matched control used in previous eating disorder prevention work, media advocacy (MA).

详细描述

Although often overlooked, eating disorders in men are a serious and deadly public health problem, affecting up to 7 million men in the United States. Efficacious eating disorder treatments largely remain unknown, particularly for men. Over recent decades, men have faced increasing social pressures to obtain an unrealistically lean and muscular physique, which have contributed to body dissatisfaction and unhealthy eating and weight control behaviors among men, including symptoms of both eating disorders and muscle dysmorphia (body image disturbance characterized by the unhealthy pursuit of muscularity. Despite the impairment and distress associated with these conditions, males are less likely to seek treatment than females, in part due to stigma. Importantly, for those men who do seek help, existing treatments are targeted mostly towards females, rarely address male-specific risk factors, and are ineffective for over 50% of patients. Thus, well-accepted, easily replicable preventative programs that target male-specific Eating Disorder risk factors prior to disorder onset are critical to reduce the public health burden and disparities associated with eating disorders in men.

Research supports that for men, pressures from media, friends, partners, and family to pursue a lean, muscular body can lead to body-ideal internalization -- the belief that one's self-worth and value are defined by physical appearance. This can lead to dissatisfaction with muscularity and body fat, which in turn, contributes to eating disorder and muscle dysmorphia-related attitudes and behaviors. Thus, targeting internalization of the lean, muscular ideal portrayed in media culture would be important for reducing both eating disorder and muscle dysmorphia symptoms for men.

While studies have targeted body-ideal internalization in groups of women using dissonance-based interventions, until recently, no programs had been developed to address internalization of the lean, muscular body ideal for men. The investigators recently developed and evaluated the Body Project: More than Muscles (MTM) in a randomized controlled trial (RCT) to target eating disorder and muscle dysmorphia risk factors in body-dissatisfied men. Results demonstrated significantly greater decreases in body-ideal internalization, dietary restraint, drive for muscularity, bulimic symptoms (e.g., binge eating, self-induced vomiting, laxatives, fasting, and/or excessive exercise), and muscle dysmorphia symptoms for men in the MTM intervention compared to assessment-only controls, both pre- to post-intervention and at 1-month follow- up. Further, body-ideal internalization mediated intervention outcomes for bulimic and muscle dysmorphia symptoms, supporting that the intervention's effects were exerted through reducing internalization of lean, muscular ideal images portrayed in media.

While initial results for MTM are promising, prior to disseminating this program to a wider audience, the present study will replicate and extend effects observed in the previous trial by comparing the intervention to a time- and attention-matched media advocacy (MA) active control condition used in previous eating disorder prevention programs. The present study will also explore the impact of MTM on additional risk factors for eating disorders and muscle dysmorphia in men not explicitly included in the previous RCT including unhealthy exercise, self- and other-objectification, appearance- and performance-enhancing drug (APED) use, and overall levels of depression, stress, and anxiety.

Results from the present study will provide critical support to help translate research on eating disorders and muscle dysmorphia in men into evidence-based prevention of these problems. If results support the intervention's efficacy, this could lead to the expanded delivery of the intervention into university-based or online effectiveness trials to help prevent eating disorders and reduce body dissatisfaction for men at a national level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants will remain unaware of what group they have been randomized to as both groups will be actively be participating in groups focused on male body image

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •18 to 30 years old
  • •Identify as male
  • •Endorse body image concerns
  • •Speak English and able to provide informed consent

排除标准

  • •Diagnosis of a DSM-5 eating disorder determined by SCID-5
  • •Significant neuropsychiatric illness (e.g., dementia, untreated severe psychiatric illness determined by SCID-unmedicated bipolar disorder, psychosis, or active suicidal ideation)
  • •Older than 30 years old
  • •Younger than 18 years old
  • •Non-English speaking

研究组 & 干预措施

Media Advocacy (MA)

Active Comparator

Participants assigned to this condition take place in a time and attention-matched active control where they discuss the role of media in promoting the body ideal.

干预措施: Media Advocacy (MA) (Behavioral)

Body Project: More than Muscles (MTM)

Experimental

Participants assigned to this condition take part in a two-session intervention based on dissonance theory which encourages them to challenge the body ideal.

干预措施: More than Muscles (MTM) (Behavioral)

结局指标

主要结局

Muscularity Oriented Eating Test (MOET)

时间窗: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

The MOET is a 15-item measure scored on a 5-point rating scale with scores ranging from 0 to 60. Higher scores on the MOET indicate greater muscularity-related disordered eating.

Eating Disorder Examination Questionnaire (EDE-Q)

时间窗: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

The EDE-Q is a 28-item measure scored on a 7-point rating scale with scores ranging from 0 to 168 (scores higher than 4 on individual questions are indicative of clinical levels). The EDE-Q is a transdiagnostic measure of Eating Disorder symptoms with high scores indicating elevated eating pathology.

Muscle Dysmorphic Disorder Inventory (MDDI)

时间窗: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

The MDDI is a 13-item measure for muscle dysmorphia symptoms, which is a common feature of Eating Disorders in men. Items are scored 0 (never) to 4 (always) with higher scores indicating greater muscle dysmorphic symptoms. Scores on this measure range 0 to 52.

Eating Pathology Symptom Inventory (EPSI)

时间窗: change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up

The EPSI is a 45-item measure scored on a 5-point rating scale with scores ranging from 0 to 4 on individual questions. The EPSI measures eating pathology across eight dimensions with higher scores indicating greater eating pathology.

Eating Pathology Symptom Inventory-Clinician Rated Version (EPSI-CRV

时间窗: Change from baseline to 6-month follow-up related to dimensional changes in Eating Disorder-related psychopathology

The EPSI-CRV is a semi-structured interview that assesses dimensional constructs of psychopathology associated with Diagnostic and Statistical Manual-5 Eating Disorders. The interview will take approximately 40 minutes to complete.

次要结局

  • Male Body Attitudes Scale (MBAS)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Self-Objectification Questionnaire (SOQ)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Obligatory Exercise Questionnaire (OEQ)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Appearance and Performance Enhancing Drug Use (APED; questions were derived from the Adolescents Training and Learning to Avoid Steroids [ATLAS] study)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Difficulties in Emotion Regulation Scale (DERS) short form(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Intervention Acceptability(Immediately post-intervention)
  • Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Drive for Muscularity Scale (DMS)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Depression, Anxiety, Stress Scale (DASS-21)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)
  • Acceptance and Action Questionnaire 2 (AAQ-II)(change from baseline to immediately post-intervention, change from baseline to 1-month follow-up, and change from baseline to 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiffany Brown

Assistant Professor

Auburn University

研究点 (1)

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