Chronic Pain, Obesity
Conditions
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.
Interventions
BEHAVIORALIntervention Simultaneously Targeting Obesity and Pain
BEHAVIORALWeight Loss/Weight Self-Management
BEHAVIORALChronic Pain Self-Management
Sponsors
University of the Sciences in Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight from baseline to 12-months | Baseline, up to 12 months | Body weight measured using a calibrated digital scale during assessment visits. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMadelyn Ruggieri
Backup ContactResearch Assistant(s)
Outcome results
None listed