Simultaneously Targeting Obesity and Pain: The STOP Trial

NCT02100995 | Unknown

• 1 other identifier: SAP# 4100057688
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in pain disability from baseline to 12 months

  Baseline, up to 12 months

• Change in quality of life from baseline to 12 months

  Baseline, up to 12 months

Study Arms (3)

STOP Intervention

EXPERIMENTAL

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

Standard Care Weight (SCW)

ACTIVE COMPARATOR

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

Standard Care Pain (SCP)

ACTIVE COMPARATOR

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

Interventions

Intervention Simultaneously Targeting Obesity and Pain BEHAVIORAL

STOP Intervention

Weight Loss/Weight Self-Management BEHAVIORAL

Standard Care Weight (SCW)

Chronic Pain Self-Management BEHAVIORAL

Standard Care Pain (SCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Sciences in Philadelphia: lead

Study Sites (1)

University of the Sciences

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 24943851 DERIVED

MeSH Terms

Conditions

Obesity; Chronic Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Elizabeth A Janke, PhD

  University of the Sciences in Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madelyn Ruggieri

CONTACT

215-596-7185; hbrlab@usciences.edu

Research Assistant(s)

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 1, 2014
• Primary Completion: January 1, 2017
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)