Rheumatoid ArthritisEMBRACENCT04246827
Rheumatoid Arthritis Coping Enhancement
A study testing Enhanced Lifestyle Weight Management in people with Rheumatoid Arthritis and Obesity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis, Obesity, Pain
- What is being tested?
- Enhanced Lifestyle Weight Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2009to 30 Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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
- Being tested
- Enhanced Lifestyle Weight Management
- Keywords
- rheumatoid arthritis, pain, obesity
- Medical subject headings
- Arthritis, Rheumatoid, Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Lifestyle Weight ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Enhanced Lifestyle Weight Management |
| Standard Care Control | No intervention | Participants received standard care of rheumatoid arthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Participants' weight was obtained.
Measured: baseline and post-treatment (12-weeks later)
Change in waist circumference
Participants' waist circumference was measured with a standard measuring tape.
Measured: 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)
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and post-treatment (12-weeks later)
Secondary outcomes (5)
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.
Measured: baseline and post-treatment (12-weeks later)
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."
Measured: baseline and post-treatment (12-weeks later)
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.
Measured: baseline and post-treatment (12-weeks later)
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.
Measured: baseline and post-treatment (12-weeks later)
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.
Measured: baseline and post-treatment (12-weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start7 Jul 2009
- Primary completion30 Sep 2011
- Study completion30 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Rheumatology
- Responsible party
- Sponsor
- Investigators
- Francis Keefe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246827
- Sponsor's protocol ID
- Pro00017695
- Acronym
- EMBRACE
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25036564Somers 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.
PubMed 34670994
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis Coping Enhancement
- ClinicalTrials.gov ID
- NCT04246827
- Acronym / sponsor ID
- EMBRACE / Pro00017695
- Conditions
- Rheumatoid Arthritis, Obesity, Pain
- Keywords
- rheumatoid arthritis, pain, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American College of Rheumatology
- Study start
- 7 Jul 2009 (actual)
- Primary completion
- 30 Sep 2011 (actual)
- Study completion
- 30 Sep 2011 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two arms.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Lifestyle Weight Management Condition | Experimental | Behavioral: Enhanced Lifestyle Weight ManagementThe 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. |
| Standard Care Control | No intervention | –Participants received standard care of rheumatoid arthritis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Lifestyle Weight ManagementThe 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. | Behavioural | Enhanced Lifestyle Weight Management Condition |
Primary outcome
Change in weight
Time frame: baseline and post-treatment (12-weeks later)
Participants' weight was obtained.
Change in waist circumference
Time frame: baseline and post-treatment (12-weeks later)
Participants' waist circumference was measured with a standard measuring tape.
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)
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."
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.
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.
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.
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.
5 secondary outcomes
Change in physical disability
Time frame: baseline and post-treatment (12-weeks later)
Change in rheumatologist Pain Assessment
Time frame: baseline and post-treatment (12-weeks later)
Change in joint symptoms
Time frame: baseline and post-treatment (12-weeks later)
Change in grip strength
Time frame: baseline and post-treatment (12-weeks later)
Change in medication use
Time frame: baseline and post-treatment (12-weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 25036564Somers 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.
- Derived from this study: PubMed 34670994Somers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Keefe, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Lifestyle Weight Management in people with Rheumatoid Arthritis and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: baseline and post-treatment (12-weeks later)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.