Lifestyle Intervention for Rheumatoid Arthritis

Blue Cross Blue Shield of Vermont

Status: Terminated

Conditions: Lifestyle Risk Reduction; Rheumatoid Arthritis

Treatments: Behavioral: Intensive Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05554705

22-08-629-1275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

experimental

Experimental group

Description:

standard of care + lifestyle intervention

Treatment:

Behavioral: Intensive Lifestyle intervention

control

No Intervention group

Description:

no intervention (control group)