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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR076663 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling Health As Treatment (CHAT) | Other | CHAT is a control arm designed to reflect traditional clinical counselling. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SWET: Supervised Weight loss and Exercise Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Living | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42015271 | Derived | 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. | |
| 40490834 | Derived |
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Of the 26 consented participants, 24 participants met inclusion criteria and were randomized.
Participants were primarily recruited from outpatient rheumatology clinics serving Duke Health in North Carolina, USA. Additional recruitment strategies included: paper and electronic advertisements, physician referrals, and the Duke Health and Exercise Research registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Counseling Health As Treatment (CHAT) | CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks. |
| FG001 | Supervised Weight Loss and Exercise Training (SWET) | SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. SWET: Supervised Weight loss and Exercise Training: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Counseling Health As Treatment (CHAT) | CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks. |
| BG001 | Supervised Weight Loss and Exercise Training (SWET) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis. | Posted | Mean | Standard Deviation | Z-score (unitless) | Baseline and 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Counseling Health As Treatment (CHAT) | CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint and/or muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Huffman, MD, PhD | Duke University | 919-613-7797 | kim.huffman@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2024 | Jan 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2022 | Nov 30, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Randomized
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|
| CHAT: Counseling Health As Treatment | Other | Control Arm over 16 weeks. |
|
| 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]. | Baseline and 16 weeks |
| Kim 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. |
SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. SWET: Supervised Weight loss and Exercise Training: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks. |
| OG001 | Supervised Weight Loss and Exercise Training (SWET) | SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. SWET: Supervised Weight loss and Exercise Training: 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. |
|
|
|
| Secondary | 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. | One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis. | Posted | Mean | Standard Deviation | T-score (unitless) | Baseline and 16 weeks |
|
|
|
|
| Secondary | 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]. | One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 16 weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Supervised Weight Loss and Exercise Training (SWET) | SWET includes supervised aerobic (3x/w) and resistance (2x/w) training plus a weekly weight loss session. SWET: Supervised Weight loss and Exercise Training: 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. | 0 | 12 | 0 | 12 | 9 | 12 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |