Rheumatoid Arthritis Coping Enhancement (EMBRACE)

Duke University

Status: Completed

Conditions: Obesity; Pain; Rheumatoid Arthritis

Treatments: Behavioral: Enhanced Lifestyle Weight Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04246827

Pro00017695

Details and patient eligibility

About

This study will test an enhanced lifestyle behavioral weight management program that integrates pain coping strategies with a lifestyle intervention that we expect to enhance obese RA patient's ability to cope with pain-related weight challenges. In the proposed study, up to 120 obese (RA-BMI > 28) rheumatoid arthritis patients will be consented in order to randomly assign 80 patients to one of two conditions: 1) an Enhanced Lifestyle Weight Management protocol or 2) standard care control. Patients randomized to the Enhanced Lifestyle Weight Management condition will participate in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors will be integrated into a lifestyle behavioral weight loss intervention.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• had RA for at least one year
• were 18 to 85 years of age
• were obese according to established RA obesity criteria (RA-BMI > 28)
• had experienced RA pain in the last two weeks.

Exclusion criteria

• Subjects were excluded if they 1) have a significant rheumatic disorder other than RA or another organic disease that would significantly affect functioning (e.g., COPD, cancer)
• had a significant medical condition that would expose them to increased risk of a significantly adverse experience during the course of the study (e.g., a recent myocardial infarction)
• they were already involved in a regular exercise program and/or pain coping skills training program
• they had an abnormal cardiac response to exercise such as exercise-induced VT, abnormal blood pressure response, etc.,
• are pregnant at enrollment or at the initiation of intervention
• are younger than 18 years of age or older than 85 years of age
• are known or judged by the physician to be cognitively impaired (dementia, retardation, psychosis)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Enhanced Lifestyle Weight Management Condition

Experimental group

Description:

The Enhanced Lifestyle Weight Management condition participants participated in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors was integrated into a lifestyle behavioral weight loss intervention.

Treatment:

Behavioral: Enhanced Lifestyle Weight Management

Standard Care Control

No Intervention group

Description:

Participants received standard care of rheumatoid arthritis.