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临床试验/NCT04591886
NCT04591886已完成不适用

Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women

University of Colorado, Boulder2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Change in Sociocultural Pressures Around Appearance

研究概览

简要总结

This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, and an extended co-design process. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at five time points over the course of a year. Students will be recruited from two high schools and will be randomized to receive the mbv program or an assessment-only control group.

详细描述

Eating disorders have the highest mortality rate of any psychiatric condition and are the second leading cause of mental health disability among young women. Given that eating disorders have their peak onset during adolescence (ages 16-19), prevention efforts among adolescent women are critical in order to avert the onset of these chronic and disabling disorders. The mbv program targets body image and appearance related pressures, awareness of body sensations, and agency and community building skills.The program consists of 10 weekly sessions and is delivered by peer facilitators. This study will implement and evaluate the mbv program at the high school level in order to examine the extent to which the program influences young women's mental health and well-being, particularly related to eating disorder risk factors and symptoms.

Utilizing a longitudinal randomized controlled trial, the study seeks to address the following aims:

  1. To examine the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self- constructs, physical health and mood among participating high school women.
  2. To explore young women's experiences of participating in the program, including strengths and limitations and perspectives on specific activities.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • High school women, grades 9-12

排除标准

  • Prior participation in the Body Project

结局指标

主要结局

Change in Sociocultural Pressures Around Appearance

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of sociocultural pressures related to appearance (scale 1-5 with higher scores indicating higher levels of pressure)

Change in Body Dissatisfaction Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)

Change in Social Contribution Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of sense of contributing to society (scale 1-5 with higher scores indicating higher levels of contribution)

Change in Self-Liking and Self-Competence Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of how much one likes oneself and considers oneself competent (scale 1-5 with higher scores indicating higher levels of self-liking and self-competence)

Change in Dieting Behavior and Restraint

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of dieting behavior and restricted eating (scale 1-5 with higher scores indicating higher levels of dieting and restriction)

Change in Ideal Body Stereotype Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of internalization of ideal body stereotypes (scale 1-5 with higher scores indicating higher levels of internalization)

Change in Engaged Living Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of values-based living (scale 1-5 with higher scores indicating higher levels of living based on values)

Change in Proactive Coping Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)

Change in Internalization of Media Appearance Ideals

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of internalized appearance ideals in the media (scale 1-5 with higher scores indicating higher levels of internalization)

Change in Peer Influence on Appearance Concerns

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of influence of peers on appearance concerns (scale 1-5 with higher scores indicating higher levels of peer influence)

Change in Objectified Body Consciousness Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of body monitoring and surveillance (scale 1-5 with higher scores indicating higher levels of body surveillance)

Change in Body Appreciation Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)

Change in Multidimensional Assessment of Interoceptive Awareness

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of somatic awareness (scale 1-5 with higher scores indicating higher levels of somatic awareness)

Change in Self-Efficacy Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of effectiveness in handling challenges and achieving goals (scale 1-5 with higher scores indicating higher levels of self-efficacy)

Change in Belonging Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)

Change in Group Belonging Scale (intervention group only)

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of sense of anticipated (baseline) and experienced (follow-up) belonging with intervention program group (scale 1-7 with higher scores indicating higher levels of belonging)

Change in Self-Compassion Scale

时间窗: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)

次要结局

  • Change in Generalized Anxiety Disorder 7(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in UCLA Loneliness Scale(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in Eating Disorder Symptoms and Diagnoses(baseline, post-intervention (10 weeks after baseline),)
  • Change in Patient Health Questionnaire 9(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in Eating Attitudes Test 26(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in Positive and Negative Affect Scale(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in School Engagement and Belonging(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in School Grades and Attendance(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in Humanitarian Egalitarian Scale(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)
  • Change in Physical Health Questionnaire(baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up)

研究者

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

Sona Dimidjian

PI

University of Colorado, Boulder

研究点 (2)

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