Simultaneously Targeting Obesity and Pain: The STOP Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial

Conditions
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Obesity, Chronic Pain

Intervention / Treatment
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* Behavioral: Intervention Simultaneously Targeting Obesity and Pain
* Behavioral: Weight Loss/Weight Self-Management
* Behavioral: Chronic Pain Self-Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STOP Intervention<br>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. | Behavioral: Intervention Simultaneously Targeting Obesity and Pain<br> <br> |
| Active Comparator: Standard Care Weight (SCW)<br>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. | Behavioral: Weight Loss/Weight Self-Management<br> <br> |
| Active Comparator: Standard Care Pain (SCP)<br>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. | Behavioral: Chronic Pain Self-Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline to 12-months | Body weight measured using a calibrated digital scale during assessment visits. | Baseline, up to 12 months | 
| Change in pain intensity from baseline to 12 months | Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable). | Baseline, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain disability from baseline to 12 months | As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI). | Baseline, up to 12 months | 
| Change in quality of life from baseline to 12 months | As measured by the SF-36. | Baseline, up to 12 months |