Recruiting

STOP Trial

Sponsor:

University of the Sciences in Philadelphia

Code:

NCT02100995

Conditions

Obesity

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention Simultaneously Targeting Obesity and Pain

Weight Loss/Weight Self-Management

Chronic Pain Self-Management

Study Details

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.

Conditions

Obesity

Chronic Pain

Study ID

NCT02100995

Status verified date

Apr, 2016

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STOP Intervention

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.

active comparator: Standard Care Weight (SCW)

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.

active comparator: Standard Care Pain (SCP)

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.

Interventions

Intervention Simultaneously Targeting Obesity and Pain

Weight Loss/Weight Self-Management

Chronic Pain Self-Management

Primary outcome measure

  • Change in weight from baseline to 12-months [ Time Frame: Baseline, up to 12 months ]
  • Change in pain intensity from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]

Central Contacts and Locations

Central contacts

Madelyn Ruggieri

215-596-7185hbrlab@usciences.edu

Locations

University of the Sciences

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of the Sciences in Philadelphia

Last update posted

Apr 15, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of the Sciences in Philadelphia on 2016-04-15.