Simultaneously Targeting Obesity and Pain: The STOP Trial

University of the Sciences in Philadelphia

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Obesity Chronic Pain

Interventions

Intervention Simultaneously Targeting Obesity and PainBEHAVIORAL

Weight Loss/Weight Self-ManagementBEHAVIORAL

Chronic Pain Self-ManagementBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of the Sciences

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Change in weight from baseline to 12-months

Body weight measured using a calibrated digital scale during assessment visits.

Time frame: 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).

Time frame: Baseline, up to 12 months

Secondary Outcomes

Change in pain disability from baseline to 12 months

As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).

Time frame: Baseline, up to 12 months

Change in quality of life from baseline to 12 months

As measured by the SF-36.

Time frame: Baseline, up to 12 months

Central Contacts

Madelyn Ruggieri

CONTACT

215-596-7185 hbrlab@usciences.edu

Research Assistant(s)

CONTACT

Data from ClinicalTrials.gov

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