Simultaneously Targeting Obesity and Pain: The STOP Trial

University of the Sciences in Philadelphia

Status: Unknown

Conditions: Chronic Pain; Obesity

Treatments: Behavioral: Chronic Pain Self-Management; Behavioral: Intervention Simultaneously Targeting Obesity and Pain; Behavioral: Weight Loss/Weight Self-Management

Study type: Interventional

Funder types: Other

Identifiers

NCT02100995

SAP# 4100057688

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

STOP Intervention

Experimental group

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.

Treatment:

Behavioral: Intervention Simultaneously Targeting Obesity and Pain

Standard Care Weight (SCW)

Active Comparator group

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.

Treatment:

Behavioral: Weight Loss/Weight Self-Management

Standard Care Pain (SCP)

Active Comparator group

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.

Treatment:

Behavioral: Chronic Pain Self-Management