Rheumatoid Arthritis Coping Enhancement
Completed · Not applicable
Conditions studied: Rheumatoid Arthritis, Obesity, Pain
In brief
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.
Key facts
- Study ID
- NCT04246827
- Run by
- Duke University
- People needed
- 50
- Starts
- 2009-07-07
- Expected to finish
- 2011-09-30
- Last updated by the study team
- 2020-01-29
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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