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

Primary Purpose

Obesity, Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Simultaneously Targeting Obesity and Pain
Weight Loss/Weight Self-Management
Chronic Pain Self-Management
Sponsored by
University of the Sciences in Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of the SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

STOP Intervention

Standard Care Weight (SCW)

Standard Care Pain (SCP)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in weight from baseline to 12-months
Body weight measured using a calibrated digital scale during assessment visits.
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).

Secondary Outcome Measures

Change in pain disability from baseline to 12 months
As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).
Change in quality of life from baseline to 12 months
As measured by the SF-36.

Full Information

First Posted
March 24, 2014
Last Updated
April 13, 2016
Sponsor
University of the Sciences in Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02100995
Brief Title
Simultaneously Targeting Obesity and Pain: The STOP Trial
Acronym
STOP
Official Title
A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Sciences in Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
STOP Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care Weight (SCW)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care Pain (SCP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Simultaneously Targeting Obesity and Pain
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss/Weight Self-Management
Intervention Type
Behavioral
Intervention Name(s)
Chronic Pain Self-Management
Primary Outcome Measure Information:
Title
Change in weight from baseline to 12-months
Description
Body weight measured using a calibrated digital scale during assessment visits.
Time Frame
Baseline, up to 12 months
Title
Change in pain intensity from baseline to 12 months
Description
Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Baseline, up to 12 months
Secondary Outcome Measure Information:
Title
Change in pain disability from baseline to 12 months
Description
As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).
Time Frame
Baseline, up to 12 months
Title
Change in quality of life from baseline to 12 months
Description
As measured by the SF-36.
Time Frame
Baseline, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madelyn Ruggieri
Phone
215-596-7185
Email
hbrlab@usciences.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Research Assistant(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Janke, PhD
Organizational Affiliation
University of the Sciences in Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Sciences
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
24943851
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.
Results Reference
derived

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Simultaneously Targeting Obesity and Pain: The STOP Trial

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