Lifestyle Intervention for Rheumatoid Arthritis

A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes

The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Intensive Lifestyle intervention

Detailed Description

The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Berlin, Vermont, United States, 05602
      • Blue Cross Blue Shield of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
2. BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
3. Age 18 or older
4. Medical diagnosis of RA

Exclusion Criteria:

1. Pregnancy
2. Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
3. Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
4. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; standard of care + lifestyle intervention	Behavioral: Intensive Lifestyle intervention; 12 week therapeutic lifestyle change program
No Intervention: control; no intervention (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HAQ-2 score	The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality.	Up to 24 months
Change in serum C-Reactive Protein	CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dosage of RA-related medications	Dosage of Medications Taken Specifically for Rheumatoid Arthritis	Up to 24 months
Change in the number of medications required to treat RA	Number of Medications Taken Specifically for Rheumatoid Arthritis	Up to 24 months
Change in RA-related costs for the study participant	Out of Pocket costs related to Rheumatoid Arthritis Care	Up to 24 months
Change in RA-related costs to the insurer	Costs for care of Rheumatoid Arthritis paid by insurer	Up to 24 months
Change in serum LDL cholesterol	Elevated Low Density Lipoprotein is strongly associated with heart disease	Up to 24 months
Change in serum total cholesterol	Elevated total cholesterol is associated with heart disease	Up to 24 months
Change in serum HbA1c	Hemoglobin HbA1c is used to assess glucose control in diabetics	Up to 24 months
Change in blood pressure	Blood pressure change	Up to 24 months
Change in BMI	Body Mass Index change	Up to 24 months
Change in weight	Weight change	Up to 24 months

Collaborators and Investigators

• Sponsor: Blue Cross Blue Shield of Vermont
• Investigators: Principal Investigator: Keri LeCompte, PharmD, Blue Cross Blue Shield of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 22-08-629-1275

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