NCT04246827|Completed
Rheumatoid Arthritis Coping Enhancement
EMBRACE
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EMBRACE
Sponsor study identifier
interventional
50
1 country
1
Study Start
July 7, 2009
Actual (reported)Primary Completion
September 30, 2011
Actual (reported)Study Completion
September 30, 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2009
Actual (reported)September 30, 2011
Actual (reported)September 30, 2011
Actual (reported)January 28, 2020
Actual (reported)January 29, 2020
Actual (reported)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."
Change in physical disability
baseline and post-treatment (12-weeks later)
Change in rheumatologist Pain Assessment
baseline and post-treatment (12-weeks later)
Change in joint symptoms
baseline and post-treatment (12-weeks later)
Change in grip strength
baseline and post-treatment (12-weeks later)
Change in medication use
baseline and post-treatment (12-weeks later)
Change in Arthritis Self-Efficacy Scale (ASES)
baseline and post-treatment (12-weeks later)
Change in self-efficacy for weight control
baseline and post-treatment (12-weeks later)
Change in Pain Catastrophizing
baseline and post-treatment (12-weeks later)
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.
Participants received standard care of rheumatoid arthritis.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke University Medical Center
Durham, North Carolina, 27705, United States
Somers TJ, Wren AA, Blumenthal JA, Caldwell D, Huffman KM, Keefe FJ. Pain, physical functioning, and overeating in obese rheumatoid arthritis patients: do thoughts about pain and eating matter? J Clin Rheumatol. 2014 Aug;20(5):244-50. doi: 10.1097/RHU.0000000000000124.
Somers TJ, Blumenthal JA, Dorfman CS, Huffman KM, Edmond SN, Miller SN, Wren AA, Caldwell D, Keefe FJ. Effects of a Weight and Pain Management Program in Patients With Rheumatoid Arthritis With Obesity: A Randomized Controlled Pilot Investigation. J Clin Rheumatol. 2022 Jan 1;28(1):7-13. doi: 10.1097/RHU.0000000000001793.
Francis Keefe, PhD
Duke University
50 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2020
First Posted
January 29, 2020
Study Start
July 7, 2009
Actual (reported)Community Based Obesity Prevention Among Black Women
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)
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2011
Actual (reported)Study Completion
September 30, 2011
Actual (reported)Last Updated
January 29, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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