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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100995
Recruitment Status : Unknown
Verified April 2016 by Elizabeth Amy Janke, University of the Sciences in Philadelphia.
Recruitment status was:  Recruiting
First Posted : April 1, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth Amy Janke, University of the Sciences in Philadelphia

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.

Condition or disease Intervention/treatment Phase
Obesity Chronic Pain Behavioral: Intervention Simultaneously Targeting Obesity and Pain Behavioral: Weight Loss/Weight Self-Management Behavioral: Chronic Pain Self-Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in weight from baseline to 12-months [ Time Frame: Baseline, up to 12 months ]
    Body weight measured using a calibrated digital scale during assessment visits.

  2. Change in pain intensity from baseline to 12 months [ Time Frame: Baseline, up 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 :
  1. Change in pain disability from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]
    As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).

  2. Change in quality of life from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]
    As measured by the SF-36.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100995


Contacts
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Contact: Madelyn Ruggieri 215-596-7185 hbrlab@usciences.edu
Contact: Research Assistant(s)

Locations
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United States, Pennsylvania
University of the Sciences Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of the Sciences in Philadelphia
Investigators
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Principal Investigator: Elizabeth A Janke, PhD University of the Sciences in Philadelphia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Amy Janke, Assistant Professor of Psychology, University of the Sciences in Philadelphia
ClinicalTrials.gov Identifier: NCT02100995    
Other Study ID Numbers: SAP# 4100057688
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Obesity
Chronic Pain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pain
Neurologic Manifestations