Multi-site Trial of a Virtually Delivered Eating Disorder Prevention Program for Young People with Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Change over time in Ideal Body Beliefs
研究概览
简要总结
This study aims to test the effectiveness of an evidence-based eating-disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.
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
- Single (Investigator)
盲法说明
The assessor completing the interview at each follow-up assessment following completion of the intervention will be blinded to the condition the participant was in.
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 14-35
- •diagnosis of Type 1 Diabetes of at least 1 year
- •using insulin
- •experiencing at least some level of body image concerns
排除标准
- •not between the ages of 14-35
- •does not have access to wifi (will need for the virtual groups)
- •Type 1 Diabetes diagnosis of less than 1 year
- •does not live in the same time zone of Stanford (helps in coordinating groups)
- •hospitalized for eating disorder treatment in the past year
- •had eating-disorder related Diabetic Ketoacidosis (DKA) in the past year
- •not using insulin
- •not experiencing any level of body image concerns
- •Unwilling to be video-recorded if assigned to Diabetes Body Project
- •restricted proficiency in language that groups will be conducted in (dependent on location), and pervasive developmental, cognitive, or psychiatric limitations that compromise participation in the intervention sessions and study.
结局指标
主要结局
Change over time in Ideal Body Beliefs
时间窗: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.
Change over time in Diabetes-Specific Eating Pathology
时间窗: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Assessed with the 16-item Diabetes Eating Problem Survey-Revised (DEPS-R; Markowitz et al,.2010). Each item is assessed on a scale of 0 = Never to 5= Always. Higher scores indicate greater eating pathology specific to individuals with Type 1 Diabetes such as purposefully not taking enough insulin.
Change over time in Body Dissatisfaction
时间窗: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction.
Change in Eating Disorder Symptoms
时间窗: pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention]
Participants will complete a diagnostic interview that is administered by a trained research assistant. We will be using the Eating Disorder Diagnostic Interview (EDDI). Scores are not reported on a scale. The research assistant who conducts the diagnostic interview at post-test and 3-month follow-up will be blinded to the person's condition.
次要结局
- Change in Glycemic Control(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
- Change in Health Care Utilization(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
- Change over time in Diabetes-Related Quality of Life(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
- Change in Time-In-Range (TIR)(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
- Change over time in Diabetes-Specific Distress(pre intervention obtained on intake, immediately post intervention, 6 months, 1-year, and 2-years after the conclusion of the intervention])
研究者
Line Wisting
Researcher
Oslo University Hospital