Rheumatoid Arthritis Coping Enhancement (EMBRACE)

January 28, 2020 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced Lifestyle Weight Management Condition
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
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.
No Intervention: Standard Care Control
Participants received standard care of rheumatoid arthritis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: baseline and post-treatment (12-weeks later)
Participants' weight was obtained.
baseline and post-treatment (12-weeks later)
Change in waist circumference
Time Frame: baseline and post-treatment (12-weeks later)
Participants' waist circumference was measured with a standard measuring tape.
baseline and post-treatment (12-weeks later)
Change in body mass index
Time Frame: baseline and post-treatment (12-weeks later)
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
Time Frame: baseline and post-treatment (12-weeks later)
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
Time Frame: baseline and post-treatment (12-weeks later)
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
Time Frame: baseline and post-treatment (12-weeks later)
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
Time Frame: baseline and post-treatment (12-weeks later)
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
Time Frame: baseline and post-treatment (12-weeks later)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in physical disability
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in rheumatologist Pain Assessment
Time Frame: baseline and post-treatment (12-weeks later)
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."
baseline and post-treatment (12-weeks later)
Change in joint symptoms
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in grip strength
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in medication use
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Arthritis Self-Efficacy Scale (ASES)
Time Frame: baseline and post-treatment (12-weeks later)
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."
baseline and post-treatment (12-weeks later)
Change in self-efficacy for weight control
Time Frame: baseline and post-treatment (12-weeks later)
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."
baseline and post-treatment (12-weeks later)
Change in Pain Catastrophizing
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in Physical activity
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in eating behavior.
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in Mood
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change in relationship satisfaction
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)
Change caloric intake
Time Frame: baseline and post-treatment (12-weeks later)
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.
baseline and post-treatment (12-weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American College of Rheumatology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francis Keefe, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00017695

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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