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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STOP Intervention | Experimental | 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) | Active Comparator | 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. |
|
| Standard Care Pain (SCP) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Simultaneously Targeting Obesity and Pain | Behavioral |
| ||
| Weight Loss/Weight Self-Management |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madelyn Ruggieri | Contact | 215-596-7185 | hbrlab@usciences.edu | |
| Research Assistant(s) | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Janke, PhD | University of the Sciences in Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Sciences | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24943851 | Derived | Janke EA, Fritz M, Hopkins C, Haltzman B, Sautter JM, Ramirez ML. A randomized clinical trial of an integrated behavioral self-management intervention Simultaneously Targeting Obesity and Pain: the STOP trial. BMC Public Health. 2014 Jun 18;14:621. doi: 10.1186/1471-2458-14-621. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Behavioral |
|
| Chronic Pain Self-Management | Behavioral |
|
As measured by the SF-36.
| Baseline, up to 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |