The Effect of Brief Versus Individually Tailored Dietary Advice on Change in Lipids, Blood Pressure, and Diet in Patients With Inflammatory Joint Disease

Diakonhjemmet Hospital

Status: Enrolling

Conditions: Spondyloarthritis; Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Other: Individually tailored diet counseling; Other: The brief standardized 4-minute heart healthy dietary advice

Study type: Interventional

Funder types: Other

Identifiers

NCT05772325

Protocol 03 02 23

Details and patient eligibility

About

A randomized controlled study comparing brief dietary intervention with a personal, tailored dietary advice (60 min) on change in LDL-c and change in diet.

Full description

Patients with inflammatory joint diseases (IJD) as rheumatoid arthritis (RA), spondylo arthropathy (SpA) and psoriatic arthritis (PsA) are at high risk of atherosclerotic cardiovascular disease. International recommendations for the prevention of cardiovascular disease recommend smoking cessation, physical activity, and dietary changes as part of treatment. Despite the evidence that behavioral counseling reduces overall cardiovascular risk, it is often an overlooked and underemphasized by clinicians. As of today, there is a knowledge gap regarding the efficacy of less intensive counseling sessions needed to obtain changes in dietary habits and clinical effects on CVD risk factors. Therefore, a brief dietary advice would be preferable if it could give a positive change in dietary habits and cholesterol. We have previously shown in a pilot study (8) that a 4 min. brief advice compared to a 60 min. personal tailored advice by a dietician on heart-friendly diet gave a similar change in dietary habits and LDL-c after 8 weeks in patients with IJD. The aim of the Diet Study is to perform a randomized controlled study comparing brief intervention (4 min) with a personal tailored dietary advice (60 min) on change in LDL-c and change in diet.

Enrollment: 70 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with either RA, PsA, or AS, between 30-80 years with an increased risk of future CVD, estimated using the CVD risk calculator. i.e. any risk > 5 -10 % predicted by Systematic Coronary Risk Evaluation (SCORE2) algorithm. Also, patients with very high risk (predicted risk >10%) as well as established atherosclerotic CVD (ASCVD) including previous myocardial infarction, coronary intervention (coronary artery bypass grafting or percutaneous coronary intervention), transient ischemic attack/strokes, atherosclerotic diseases of arteries as in the carotid artery or peripheral arterial disease (PAD) will also be included.

Exclusion criteria

1. Heart failure with systolic EF<40%
2. Kidney failure with GFR < 35
3. Liver failure
4. Mental disorder rendering the patient unable to comply with the protocol
5. Being able to speak the language of the country
6. Reduced cognitive function
7. Substance abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Brief standardized dietary advice

Active Comparator group

Description:

The brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists.

Treatment:

Other: The brief standardized 4-minute heart healthy dietary advice

Individually tailored diet counseling

Experimental group

Description:

Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian.

Treatment:

Other: Individually tailored diet counseling