Rheumatoid ArthritisSWET/CHATNCT04356183
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
A study testing SWET: Supervised Weight loss and Exercise Training and CHAT: Counseling Health As Treatment in people with Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial summary
This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SWET: Supervised Weight loss and Exercise Training and CHAT: Counseling Health As Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) 28-40 kg/m2.
- Must have internet access.
- Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
Who cannot join
- Subject unwilling/unable to utilize online platforms (e.g. ZOOM, REDCap, Pattern Health) for study activities.
- Current use of biologic agents other than those targeting tumor necrosis factor alpha.
- Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
- Participating in regular exercise within the past 3 months (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
- New medications within the last three months and stable doses for ≥ 1 month.
- Diagnosis of coronary artery disease.
Show all 12Show fewer
- Diagnosis of type 2 diabetes mellitus.
- Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease.
- Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection.
- Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.
- Significant weight change (gain or loss of > 10 pounds in 1 month) within the past 6 months.
- Unwillingness or inability to adhere to the diet structure of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27705
About this study
This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SWET: Supervised Weight loss and Exercise Training, CHAT: Counseling Health As Treatment
- Keywords
- RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWET: Supervised Weight loss and Exercise TrainingOther
Weight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence.
CHAT: Counseling Health As TreatmentOther
Control Arm over 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Counseling Health As Treatment (CHAT) | Other | CHAT is a control arm designed to reflect traditional clinical counselling. Receives: Other: CHAT: Counseling Health As Treatment |
| Supervised Weight loss and Exercise Training (SWET) | Experimental | SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. Receives: Other: SWET: Supervised Weight loss and Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Severity Z-score (MSSc)
The primary objective is to compare change in metabolic syndrome z-score (MSSc) between groups. The MSSc is a continuous weighted score of the five metabolic syndrome variables-fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and mean arterial blood pressure. A modified z-score was calculated for each participant using continuous differences between the Adult Treatment Panel (ATP) III guideline values and participant values with normalization to the cohort's standard deviations. To account for variations in ATP III criteria between men and women, the investigators used sex-specific MSSc equations. A lower MSSc indicates a better outcome.
Measured: Baseline and 16 weeks
Secondary outcomes (2)
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire
Change in patient-reported outcomes using PROMIS Physical Function Questionnaire. The questionnaire was scored using "response pattern scoring" according to the PROMIS scoring manual in order to calculate the T-score for this outcome measure. The population mean T-score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average.
Measured: Baseline and 16 weeks
Disease Activity Score (DAS-28)
Change in disease activity measured using the DAS-28. DAS-28 is a composite measure including a self-reported overall health assessment on a 100 mm visual analog scale, the number of tender and swollen joints determined from a 28-joint examination, and C-reactive protein. Scores range from 0 [very well] to 10 [very poor].
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start21 Jul 2021
- Primary completion3 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356183
- Sponsor's protocol ID
- Pro00104843
- Other IDs
- R21AR076663
- Acronym
- SWET/CHAT
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2020
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hashmi SW, Andonian BJ, Thompson MM, Bennett WC, Sudnick AM, Johnson JL, Ross LM, Collins-Bennett KA, Belski KB, Vinicki M, Pribic T, Lauc G, Krishnan S, Huffman KM. Immunoglobulin G and plasma glycome in early rheumatoid arthritis differ from matched controls and link less fat-free mass to an accelerated aging phenotype: an exploratory study. Arthritis Res Ther. 2026 Apr 21;28(1):123. doi: 10.1186/s13075-026-03818-6.
PubMed 42015271Kim G, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Connelly MA, Ilkayeva O, Muehlbauer MJ, Bales CW, Porter Starr KN, Kraus WE, Andonian BJ, Huffman KM. The impact of lifestyle modification on metabolic pathways in older adults with overweight/obesity and rheumatoid arthritis: a secondary exploratory analysis of the SWET-RA study. BMC Rheumatol. 2025 Jun 9;9(1):68. doi: 10.1186/s41927-025-00525-8.
PubMed 40490834
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT04356183
- Acronym / sponsor ID
- SWET/CHAT / Pro00104843
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA Seropositive, RA Erosive, Exercise, Diet, Nutrition, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Counseling Health As Treatment (CHAT) | Other | Other: CHAT: Counseling Health As TreatmentCHAT is a control arm designed to reflect traditional clinical counselling. |
| Supervised Weight loss and Exercise Training (SWET) | Experimental | Other: SWET: Supervised Weight loss and Exercise TrainingSWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 28-40 kg/m2.
- Must have internet access.
- Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
Key exclusion criteria (12 listed)
- Subject unwilling/unable to utilize online platforms (e.g. ZOOM, REDCap, Pattern Health) for study activities.
- Current use of biologic agents other than those targeting tumor necrosis factor alpha.
- Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
- Participating in regular exercise within the past 3 months (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
- New medications within the last three months and stable doses for ≥ 1 month.
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 |
|---|---|---|
| SWET: Supervised Weight loss and Exercise TrainingWeight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence. | Other | Supervised Weight loss and Exercise Training (SWET) |
| CHAT: Counseling Health As TreatmentControl Arm over 16 weeks. | Other | Counseling Health As Treatment (CHAT) |
Primary outcome
Metabolic Syndrome Severity Z-score (MSSc)
Time frame: Baseline and 16 weeks
The primary objective is to compare change in metabolic syndrome z-score (MSSc) between groups. The MSSc is a continuous weighted score of the five metabolic syndrome variables-fasting high-density lipoprotein cholesterol, triglycerides, glucose, waist circumference, and mean arterial blood pressure. A modified z-score was calculated for each participant using continuous differences between the Adult Treatment Panel (ATP) III guideline values and participant values with normalization to the cohort's standard deviations. To account for variations in ATP III criteria between men and women, the investigators used sex-specific MSSc equations. A lower MSSc indicates a better outcome.
2 secondary outcomes
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire
Time frame: Baseline and 16 weeks
Disease Activity Score (DAS-28)
Time frame: Baseline and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42015271Hashmi SW, Andonian BJ, Thompson MM, Bennett WC, Sudnick AM, Johnson JL, Ross LM, Collins-Bennett KA, Belski KB, Vinicki M, Pribic T, Lauc G, Krishnan S, Huffman KM. Immunoglobulin G and plasma glycome in early rheumatoid arthritis differ from matched controls and link less fat-free mass to an accelerated aging phenotype: an exploratory study. Arthritis Res Ther. 2026 Apr 21;28(1):123. doi: 10.1186/s13075-026-03818-6.
- Derived from this study: PubMed 40490834Kim G, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Connelly MA, Ilkayeva O, Muehlbauer MJ, Bales CW, Porter Starr KN, Kraus WE, Andonian BJ, Huffman KM. The impact of lifestyle modification on metabolic pathways in older adults with overweight/obesity and rheumatoid arthritis: a secondary exploratory analysis of the SWET-RA study. BMC Rheumatol. 2025 Jun 9;9(1):68. doi: 10.1186/s41927-025-00525-8.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWET: Supervised Weight loss and Exercise Training and CHAT: Counseling Health As Treatment in people with Rheumatoid Arthritis, 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 3 inclusion and 12 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 30 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metabolic Syndrome Severity Z-score (MSSc) (time frame: Baseline and 16 weeks). 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 NCT04356183, 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 30 Mar 2025.