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NCT04246827: EMBRACE
Rheumatoid Arthritis Coping Enhancement
NA trial testing Enhanced Lifestyle Weight Management in Rheumatoid Arthritis in 50 participants. Completed in 30 September 2011.
30 September 2011
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 7 July 2009 |
| Primary completion | 30 September 2011 |
| Estimated completion | 30 September 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Enhanced Lifestyle Weight Management
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Obesity — all drugs for Obesity →
- Pain — all drugs for Pain →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04246827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04246827 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 29 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04246827.
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