Clinical trial NCT04246827: Rheumatoid Arthritis Coping Enhancement
Official title: Rheumatoid Arthritis Coping Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Obesity
Pain
Keywords: rheumatoid arthritis
pain
obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American College of Rheumatology
First posted: 2020-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to one of two arms.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in weight
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in waist circumference
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in body mass index
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in pain as measured by the Brief Pain Inventory
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Physical Disability
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Psychological Disability
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in C-Reactive Protein
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Cyclic citrullinated peptide (CCP) antibody
timeFrame: baseline and post-treatment (12-weeks later)
Secondary outcomes:
measure: Change in physical disability
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in rheumatologist Pain Assessment
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in joint symptoms
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in grip strength
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in medication use
timeFrame: baseline and post-treatment (12-weeks later)
Other outcomes:
measure: Change in Arthritis Self-Efficacy Scale (ASES)
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in self-efficacy for weight control
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Pain Catastrophizing
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Physical activity
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in eating behavior.
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in Mood
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change in relationship satisfaction
timeFrame: baseline and post-treatment (12-weeks later)
measure: Change caloric intake
timeFrame: baseline and post-treatment (12-weeks later)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.