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

• ClinicalTrials.gov Identifier: NCT02100995
• Recruitment Status: Unknown
• First Posted: April 1, 2014
• Last Update Posted: April 15, 2016
• Sponsor: University of the Sciences in Philadelphia
• Information provided by (Responsible Party): Elizabeth Amy Janke, University of the Sciences in Philadelphia

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Madelyn Ruggieri; 215-596-7185; hbrlab@usciences.edu

Contact: Research Assistant(s)

Locations

United States, Pennsylvania

University of the Sciences; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of the Sciences in Philadelphia

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: April 15, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Obesity; Chronic Pain; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pain; Neurologic Manifestations