Clinical trial NCT02100995: Simultaneously Targeting Obesity and Pain: The STOP Trial
Official title: A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Chronic Pain
Lead sponsor: University of the Sciences in Philadelphia
Sponsor class: OTHER
First posted: 2014-04-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in weight from baseline to 12-months
timeFrame: Baseline, up to 12 months
measure: Change in pain intensity from baseline to 12 months
timeFrame: Baseline, up to 12 months
Secondary outcomes:
measure: Change in pain disability from baseline to 12 months
timeFrame: Baseline, up to 12 months
measure: Change in quality of life from baseline to 12 months
timeFrame: Baseline, up to 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of the Sciences
state: Pennsylvania
Study officials:
affiliation: University of the Sciences in Philadelphia
name: Elizabeth A Janke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.