Simultaneously Targeting Obesity and Pain: The STOP Trial

Obesity Clinical Trial

— STOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02100995
• Other study ID #: SAP# 4100057688
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2014
• Last updated: April 13, 2016

Study information

• Verified date: April 2016
• Source: University of the Sciences in Philadelphia
• Contact: Madelyn Ruggieri
• Phone: 215-596-7185
• Email: hbrlab[@]usciences.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Obesity

Intervention

Behavioral:
• Intervention Simultaneously Targeting Obesity and Pain

• Weight Loss/Weight Self-Management

• Chronic Pain Self-Management

Locations

Country	Name	City	State
United States	University of the Sciences	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of the Sciences in Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline to 12-months	Body weight measured using a calibrated digital scale during assessment visits.	Baseline, up to 12 months	No
Primary	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	No
Secondary	Change in pain disability from baseline to 12 months	As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).	Baseline, up to 12 months	No
Secondary	Change in quality of life from baseline to 12 months	As measured by the SF-36.	Baseline, up to 12 months	No