Trial Outcomes & Findings for Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk (NCT NCT04356183)

Last Updated: 2025-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2025-03-30

Participant Flow

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.

Of the 26 consented participants, 24 participants met inclusion criteria and were randomized.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	12
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counseling Health As Treatment (CHAT) n=12 Participants CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks.	Supervised Weight Loss and Exercise Training (SWET) n=12 Participants 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.	Total n=24 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 6.2 • n=93 Participants	68.1 years STANDARD_DEVIATION 5.8 • n=4 Participants	67.6 years STANDARD_DEVIATION 5.9 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	9 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.

Outcome measures

Outcome measures
Measure	Counseling Health As Treatment (CHAT) n=10 Participants CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks.	Supervised Weight Loss and Exercise Training (SWET) n=10 Participants 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.
Metabolic Syndrome Severity Z-score (MSSc) Baseline	-1.89 Z-score (unitless) Standard Deviation 2.39	-1.82 Z-score (unitless) Standard Deviation 2.01
Metabolic Syndrome Severity Z-score (MSSc) Week 16	-3.23 Z-score (unitless) Standard Deviation 2.80	-3.49 Z-score (unitless) Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.

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.

Outcome measures

Outcome measures
Measure	Counseling Health As Treatment (CHAT) n=10 Participants CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks.	Supervised Weight Loss and Exercise Training (SWET) n=10 Participants 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.
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire Baseline	41.7 T-score (unitless) Standard Deviation 5.0	42.3 T-score (unitless) Standard Deviation 6.3
Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Questionnaire 16 weeks	41.7 T-score (unitless) Standard Deviation 6.4	48.1 T-score (unitless) Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Population: One SWET participant was excluded from analysis due to prior chronic lymphocytic leukemia diagnosis.

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 \[very poor\].

Outcome measures

Outcome measures
Measure	Counseling Health As Treatment (CHAT) n=10 Participants CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks.	Supervised Weight Loss and Exercise Training (SWET) n=10 Participants 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.
Disease Activity Score (DAS-28) Baseline	3.1 score on a scale Standard Deviation 1.0	2.9 score on a scale Standard Deviation 1.2
Disease Activity Score (DAS-28) Week 16	2.9 score on a scale Standard Deviation 0.8	2.1 score on a scale Standard Deviation 0.9

Adverse Events

Counseling Health As Treatment (CHAT)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Supervised Weight Loss and Exercise Training (SWET)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Counseling Health As Treatment (CHAT) n=12 participants at risk CHAT is a control arm designed to reflect traditional clinical counselling. CHAT: Counseling Health As Treatment: Control Arm over 16 weeks.	Supervised Weight Loss and Exercise Training (SWET) n=12 participants at risk 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.
Musculoskeletal and connective tissue disorders Joint and/or muscle pain	16.7% 2/12 • 16 weeks	58.3% 7/12 • 16 weeks
Infections and infestations Infection	8.3% 1/12 • 16 weeks	41.7% 5/12 • 16 weeks
Skin and subcutaneous tissue disorders Skin disorder	8.3% 1/12 • 16 weeks	8.3% 1/12 • 16 weeks

Additional Information

Kim Huffman, MD, PhD

Duke University

Phone: 919-613-7797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place