Simultaneously Targeting Obesity and Pain: The STOP Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Contact: | Madelyn Ruggieri |
| Email: | hbrlab@usciences.edu |
| Phone: | 215-596-7185 |
A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
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