A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Change in pain intensity from baseline to 12 months
研究概览
简要总结
The purpose of this study is to determine whether an integrated behavioral treatment approach can help overweight or obese individuals who also have chronic pain reduce their weight and manage their pain symptoms. The goal of this research is to develop better treatments for individuals with chronic pain and overweight or obesity. All participants in this study will receive treatment for weight management and/or pain symptoms. Participants will be assigned at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3) Integrated behavioral treatment for weight loss and pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18
- •Body mass index (BMI) ≥ 25
- •Chronic, non-cancer pain (pain at a level ≥ 4 on a scale of 0-10 on a majority of the days for 6 months or more prior to study participation)
排除标准
- •Have an unstable medical or psychiatric condition
- •Meet criteria for current substance abuse or dependence
- •Meet the criteria for bulimia
- •Non-fluent in spoken or written English
- •Currently pregnant, pregnant within the past 6 months, trying to get pregnant in the next 3 months
- •Demonstrate significant cognitive or sensorimotor impairment precluding treatment engagement
- •Already participating in a similar structured diet or exercise program or pain self-management program or plans to begin such a program outside the study during the next month
- •At risk for significant adverse cardiovascular events with moderate activity
- •Plans to relocate within the upcoming 12 months
结局指标
主要结局
Change in pain intensity from baseline to 12 months
时间窗: Baseline, up to 12 months
Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
Change in weight from baseline to 12-months
时间窗: Baseline, up to 12 months
Body weight measured using a calibrated digital scale during assessment visits.
次要结局
- Change in pain disability from baseline to 12 months(Baseline, up to 12 months)
- Change in quality of life from baseline to 12 months(Baseline, up to 12 months)
研究者
Elizabeth Amy Janke
Assistant Professor of Psychology
University of the Sciences in Philadelphia