Rheumatoid Arthritis Coping Enhancement

NCT04246827 | Completed

• 1 other identifier: Pro00017695
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Obesity; Pain

Keywords

rheumatoid arthritis; pain; obesity

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• 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)

Other Outcomes (8)

• 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)

Study Arms (2)

Enhanced Lifestyle Weight Management Condition

EXPERIMENTAL

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

Standard Care Control

NO INTERVENTION

Participants received standard care of rheumatoid arthritis.

Interventions

Enhanced Lifestyle Weight Management BEHAVIORAL

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.

Enhanced Lifestyle Weight Management Condition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• American College of Rheumatology: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• 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.

  PMID: 25036564 BACKGROUND

• 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.

  PMID: 34670994 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Obesity; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Francis Keefe, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to one of two arms.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 29, 2020
• Study Start: July 7, 2009
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)