Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Weight Self-Stigma
研究概览
简要总结
The proposed investigation is an experimental trial among 80 adults with obesity and internalized weight bias to determine preliminary effects of a smartphone-delivered brief self-compassion mindfulness intervention on internalized weight bias, compared to wait list control. All participants will receive a 4-week mindfulness-based intervention via smartphone. Participants will be randomly assigned to one of two treatment arms: (1) the intervention group, a self-compassion mindfulness practice tailored for weight and body concerns, or (2) a wait list control group, who will receive access to the intervention content following completion of end-of-treatment assessments. All intervention content will be delivered via text message.
详细描述
The proposed investigation is an experimental trial among 80 adults with obesity and internalized weight bias to determine preliminary effects of a smartphone-delivered brief self-compassion mindfulness intervention on internalized weight bias, compared to wait list control.
All participants will receive a 4-week mindfulness-based intervention via smartphone. Participants will be randomly assigned to one of two treatment arms: (1) the intervention group, a self-compassion mindfulness practice tailored for weight and body concerns, or (2) a wait list control group, who will receive access to the intervention content following completion of end-of-treatment assessments. All intervention content will be delivered via text message using Duke REDCap with Twilio integration. The intervention group will also complete psychoeducation on internalized weight bias and self-compassion. We will measure a number of potential moderating and mediating constructs, such as depression, trauma history, etc.
Intervention Components:
Intervention Group:
Guided Mindfulness Practice: Participants in the intervention group will receive compassion-based guided meditation audio recordings made publicly available by Kristin Neff at www.selfcompassion.org and Tara Brach at www.tarabrach.com. Many of these audio files were used in a previous investigation of self-compassion and body image (Albertson et al., 2015) and were selected due to their unique ability to target compassion and body concerns simultaneously. Daily mindfulness practice will require about 4-20 minutes per day to complete (days 2-28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •BMI at least 30 kg/m2
- •Elevated weight bias internalization levels
- •Must live within Eastern Standard Time zone
- •Must own a smartphone and be willing to receive 1-2 text messages daily, practice mindfulness for approximately 20 minutes daily, and engage with weekly intervention content
排除标准
- •Under 18 years old
- •BMI < 30
- •No experienced or internalized weight bias reported
- •Lives in another time zone (not EST)
- •Currently attempting to lose weight or restrict diet
- •Currently enrolled in an intervention for weight, weight bias, self-compassion or mindfulness
- •Currently or recently a "regular meditator"
- •Plans for bariatric surgery during or immediately following intervention period
- •Investigator discretion for safety reasons
结局指标
主要结局
Change in Weight Self-Stigma
时间窗: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)
Change in Internalized Weight Bias
时间窗: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Weight Bias Internalization Scale (WBIS-M)
Change in Self-compassion
时间窗: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Self Compassion Scale (SCS)
次要结局
- Change in mindfulness(Baseline to End-of-treatment (4 weeks))