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NCT04246827: EMBRACE

Rheumatoid Arthritis Coping Enhancement

Completed NA Last updated 29 January 2020
What this trial tests

NA trial testing Enhanced Lifestyle Weight Management in Rheumatoid Arthritis in 50 participants. Completed in 30 September 2011.

Timeline
7 July 2009
Primary endpoint
30 September 2011
30 September 2011

Quick facts

Lead sponsorDuke University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment50
Start date7 July 2009
Primary completion30 September 2011
Estimated completion30 September 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

Adults 18 to 85, any sex, with Rheumatoid Arthritis or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of a Weight and Pain Management Program in Patients With Rheumatoid Arthritis With Obesity: A Randomized Controlled Pilot Investigation.
    Somers TJ, Blumenthal JA, Dorfman CS, Huffman KM, et al · · 2022 · cited 9× · PMID 34670994 · DOI 10.1097/rhu.0000000000001793

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Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

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