Rheumatoid Arthritis Coping Enhancement

Study Overview
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Brief Summary
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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.

Official Title
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Rheumatoid Arthritis Coping Enhancement

Conditions
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Obesity, Rheumatoid Arthritis, Pain

Intervention / Treatment
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* Behavioral: Enhanced Lifestyle Weight Management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomly assigned to one of two arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Lifestyle Weight Management Condition<br>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. | Behavioral: Enhanced Lifestyle Weight Management<br>* The Enhanced Lifestyle Weight Management program was 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 were integrated into a lifestyle behavioral weight loss intervention.<br>|
| No Intervention: Standard Care Control<br>Participants received standard care of rheumatoid arthritis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Participants' weight was obtained. | baseline and post-treatment (12-weeks later) | 
| Change in waist circumference | Participants' waist circumference was measured with a standard measuring tape. | baseline and post-treatment (12-weeks later) | 
| Change in body mass index | Participants' body mass index was calculated by dividing weight (in kg) by height (in m2) | baseline and post-treatment (12-weeks later) | 
| Change in pain as measured by the Brief Pain Inventory | Pain was assessed with the Brief Pain Inventory, which includes four items asking subjects to rate their usual, worst, least, and average pain during the last week. For each item, patients rate their pain using a scale ranging from 1 to 10 with 1 representing no pain and 10 representing pain as bad as you can imagine. | baseline and post-treatment (12-weeks later) | 
| Change in Physical Disability | Participants completed the physical functioning scales of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning. | baseline and post-treatment (12-weeks later) | 
| Change in Psychological Disability | Participants completed the psychological functioning scale of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning. | baseline and post-treatment (12-weeks later) | 
| Change in C-Reactive Protein | Serum samples were collected for CRP analysis. All blood specimens were collected in the morning and prior to exercise, centrifuged at 3500 rpm for 10 minutes, and serum stored at -80 degrees Celsius until analysis. CRP is an index of inflammation and activity in RA and is thought to be a more specific measure than erythrocyte sedimentation rate. | baseline and post-treatment (12-weeks later) | 
| Change in Cyclic citrullinated peptide (CCP) antibody | Cyclic cirtrullinated peptide (CCP) antibody test that is increasingly being used to measure rheumatoid arthritis disease activity, was collected from the eBrowser when available. | baseline and post-treatment (12-weeks later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical disability | The 6 minute walk test was used as an objective assessment of physical disability. This was performed indoors in our lab space, along a long, flat, straight, enclosed corridor. A starting line which marks the beginning and end of each lap was marked on the floor with a brightly colored tape. | baseline and post-treatment (12-weeks later) | 
| Change in rheumatologist Pain Assessment | The study rheumatologist completed a visual analog scale (VAS) for pain assessment. The VAS was a horizontal line 100 mm in length with anchors ranging from 0 no disease activity to 100 high disease activity. | baseline and post-treatment (12-weeks later) | 
| Change in joint symptoms | Two joint counts-of tenderness to palpation and of swelling-were obtained by the examining rheumatologist. As suggested by Fuchs and Pincus, we used a reduced count of 28 joints, and counts rather than grading of tenderness and swelling were made, as advocated by Felson et al. (29), to increase inter-observer reliability. | baseline and post-treatment (12-weeks later) | 
| Change in grip strength | Grip strength was assessed using a sphygmomanometer bulb specially designed for this purpose. Three trials with each hand were conducted, with the average of the three being the person's score. | baseline and post-treatment (12-weeks later) | 
| Change in medication use | A structured interview was carried out by the study rheumatologist at each evaluation to assess subjects' intake of medication. Subjects were asked what medications they have taken in the two weeks prior to the evaluation. Changes in intake of five categories of medication were scored by comparing data with that collected prior to treatment. The categories included will be 1) nonsteroidal anti-inflammatory drugs, 2) non-narcotic analgesics, 3) narcotics, 4) steroids, and 5) disease modifying anti-rheumatic drugs. Changes in medication were scored as dose increased, dose unchanged, or dose decreased. Based on prior research, we do not anticipate significant changes in medication to occur over the course of the study. | baseline and post-treatment (12-weeks later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, pain, obesity