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Rheumatoid Arthritis Coping Enhancement (EMBRACE)

Primary Purpose

Rheumatoid Arthritis, Obesity, Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enhanced Lifestyle Weight Management

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, pain, obesity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Lifestyle Weight Management Condition

Standard Care Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in weight

Participants' weight was obtained.

Change in waist circumference

Participants' waist circumference was measured with a standard measuring tape.

Change in body mass index

Participants' body mass index was calculated by dividing weight (in kg) by height (in m2)

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

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.

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.

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.

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.

Secondary Outcome Measures

Change in physical disability

The 6 minute walk test was used as an objective assessment of physical disability. This was performed indoors in our lab space, along a long, flat, straight, enclosed corridor. A starting line which marks the beginning and end of each lap was marked on the floor with a brightly colored tape.

Change in rheumatologist Pain Assessment

The study rheumatologist completed a visual analog scale (VAS) for pain assessment. The VAS was a horizontal line 100 mm in length with anchors ranging from 0 "no disease activity" to 100 "high disease activity."

Change in joint symptoms

Two joint counts-of tenderness to palpation and of swelling-were obtained by the examining rheumatologist. As suggested by Fuchs and Pincus, we used a reduced count of 28 joints, and counts rather than grading of tenderness and swelling were made, as advocated by Felson et al. (29), to increase inter-observer reliability.

Change in grip strength

Grip strength was assessed using a sphygmomanometer bulb specially designed for this purpose. Three trials with each hand were conducted, with the average of the three being the person's score.

Change in medication use

A structured interview was carried out by the study rheumatologist at each evaluation to assess subjects' intake of medication. Subjects were asked what medications they have taken in the two weeks prior to the evaluation. Changes in intake of five categories of medication were scored by comparing data with that collected prior to treatment. The categories included will be 1) nonsteroidal anti-inflammatory drugs, 2) non-narcotic analgesics, 3) narcotics, 4) steroids, and 5) disease modifying anti-rheumatic drugs. Changes in medication were scored as dose increased, dose unchanged, or dose decreased. Based on prior research, we do not anticipate significant changes in medication to occur over the course of the study.

Full Information

NCT ID

NCT04246827

First Posted

January 28, 2020

Last Updated

January 28, 2020

Sponsor

Duke University

Collaborators

American College of Rheumatology

1. Study Identification

Unique Protocol Identification Number

NCT04246827

Brief Title

Rheumatoid Arthritis Coping Enhancement

Acronym

EMBRACE

Official Title

Rheumatoid Arthritis Coping Enhancement

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 7, 2009 (Actual)

Primary Completion Date

September 30, 2011 (Actual)

Study Completion Date

September 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

American College of Rheumatology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Obesity, Pain

Keywords

rheumatoid arthritis, pain, obesity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants were randomly assigned to one of two arms.

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enhanced Lifestyle Weight Management Condition

Arm Type

Experimental

Arm Description

Arm Title

Standard Care Control

Arm Type

No Intervention

Arm Description

Participants received standard care of rheumatoid arthritis.

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Lifestyle Weight Management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in weight

Description

Participants' weight was obtained.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in waist circumference

Description

Participants' waist circumference was measured with a standard measuring tape.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in body mass index

Description

Participants' body mass index was calculated by dividing weight (in kg) by height (in m2)

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in pain as measured by the Brief Pain Inventory

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Physical Disability

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Psychological Disability

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in C-Reactive Protein

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Cyclic citrullinated peptide (CCP) antibody

Description

Cyclic cirtrullinated peptide (CCP) antibody test that is increasingly being used to measure rheumatoid arthritis disease activity, was collected from the eBrowser when available.

Time Frame

baseline and post-treatment (12-weeks later)

Secondary Outcome Measure Information:

Title

Change in physical disability

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in rheumatologist Pain Assessment

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in joint symptoms

Description

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in grip strength

Description

Grip strength was assessed using a sphygmomanometer bulb specially designed for this purpose. Three trials with each hand were conducted, with the average of the three being the person's score.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in medication use

Description

Time Frame

baseline and post-treatment (12-weeks later)

Other Pre-specified Outcome Measures:

Title

Change in Arthritis Self-Efficacy Scale (ASES)

Description

The Arthritis Self-Efficacy Scale (ASES) was used to assess subjects' perceived abilities to perform behaviors that would control arthritis pain and minimize disability. The ASES is a widely used instrument and has been shown to be reliable and valid. Responses for each item range from 10 to 100 where 10 is "very uncertain" and 100 is "very certain."

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in self-efficacy for weight control

Description

The Weight Efficacy Life-Style Questionnaire (WEL) is a 20-item scale used to assess subjects' perceived ability to control their weight by resisting eating across five situations (i.e., positive emotions, negative emotions, food availability, social context, physical discomfort). The WEL has demonstrated good reliability and validity. The 20-item measure asks participants to provide information about how certian they are that they can resist overeating across five situations. Response choices range from 0="not at all confident" to 9= "very confident."

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Pain Catastrophizing

Description

Pain catastrophizing was measured using the 13-item Pain Catastrophizing Scale (PCS). This scale measures subjects' tendencies to ruminate about pain, magnify pain, and feel helpless about pain. Participants are provided with a list of thoughts and feelings about pain and are asked to rate the degree to which they have these thoughts/feelings on a scale from 0=not at all to 4=all the time.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Physical activity

Description

The International Physical Activity Questionnaire (IPAQ) was used to assess change in physical activity. The IPAQ is a short assessment tool that is widely used in adult populations with chronic conditions that asks about individuals' engagement in vigorous, moderate, walking, and sedentary activity over the last 7 days.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in eating behavior.

Description

Tendencies to overeat or binge eat was measured with the Binge Eating Scale (BES). This is a self-report, 16-item questionnaire with multiple choice statements assessing how severely a person overeats. Weights are assigned to each response option ranging from 0 to 3. Higher scores indicate greater severity of over eating.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in Mood

Description

Mood changes were assessed with the condensed version of the Profile of Mood States-B (POMS). This measure uses nine adjective to assess negative and positive mood states.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change in relationship satisfaction

Description

Relationship satisfaction was measured with the Interpersonal Support Evaluations List - Short Form (ISEL-SF). This measure includes 16 items that assess perceived support from significant others in these areas: 1) availability of someone to talk to about problems, 2) tangible or instrumental support, 3) belonging support, people available to do things with, and 4) self-esteem support.

Time Frame

baseline and post-treatment (12-weeks later)

Title

Change caloric intake

Description

Daily food diaries were collected for four consecutive days following each assessment. Participants were sent home with a structured paper diary and asked to record all caloric intake (food and drink) over the four days. Participants were given instructions on how to record their food and will be instructed to contact study staff if they have any questions during the days they are recording their food.

Time Frame

baseline and post-treatment (12-weeks later)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis Keefe, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25036564

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.

Results Reference

background

PubMed Identifier

34670994

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.

Results Reference

derived

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Rheumatoid Arthritis Coping Enhancement

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