Simultaneously Targeting Obesity and Pain: The STOP Trial (STOP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Chronic Pain
• Intervention / Treatment: Behavioral: Intervention Simultaneously Targeting Obesity and Pain; Behavioral: Weight Loss/Weight Self-Management; Behavioral: Chronic Pain Self-Management

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madelyn Ruggieri; Phone Number: 215-596-7185; Email: hbrlab@usciences.edu
• Study Contact Backup: Name: Research Assistant(s)

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of the Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Intervention Simultaneously Targeting Obesity and Pain
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.	Behavioral: Weight Loss/Weight Self-Management
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.	Behavioral: Chronic Pain Self-Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	As measured by the SF-36.	Baseline, up to 12 months

Collaborators and Investigators

• Sponsor: University of the Sciences in Philadelphia
• Investigators: Principal Investigator: Elizabeth A Janke, PhD, University of the Sciences in Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Primary Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): April 1, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Chronic Pain
• Other Study ID Numbers: SAP# 4100057688