Simultaneously Targeting Obesity and Pain: The STOP Trial
- Conditions
- Chronic PainObesity
- Interventions
- Behavioral: Chronic Pain Self-ManagementBehavioral: Intervention Simultaneously Targeting Obesity and PainBehavioral: Weight Loss/Weight Self-Management
- Registration Number
- NCT02100995
- Lead Sponsor
- University of the Sciences in Philadelphia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Pain (SCP) Chronic Pain Self-Management The chronic pain intervention is focused around reconceptualization of pain, decreasing catastrophizing, and increasing self-efficacy for pain. This content has been chosen because of its demonstrated effectiveness and importance in non-pharmacological interventions to improve pain management. STOP Intervention Intervention Simultaneously Targeting Obesity and Pain The STOP treatment includes content designed to simultaneously and explicitly target both chronic pain and obesity. Treatment components are drawn from evidence-based interventions for chronic pain and obesity, separately. Standard Care Weight (SCW) Weight Loss/Weight Self-Management The weight loss intervention includes content focused around nutrition and eating habits, stimulus control and behavioral change, and physical activity. This content has been chosen because of its demonstrated effectiveness and importance in behavioral interventions to reduce weight.
- Primary Outcome Measures
Name Time Method Change in pain intensity from baseline to 12 months 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 Baseline, up to 12 months Body weight measured using a calibrated digital scale during assessment visits.
- Secondary Outcome Measures
Name Time Method Change in pain disability from baseline to 12 months Baseline, up to 12 months As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).
Change in quality of life from baseline to 12 months Baseline, up to 12 months As measured by the SF-36.
Trial Locations
- Locations (1)
University of the Sciences
🇺🇸Philadelphia, Pennsylvania, United States