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

NCT ID: NCT05772325

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-08-31

Brief Summary

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.

Detailed 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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Brief standardized dietary advice

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

Group Type: ACTIVE_COMPARATOR

The brief standardized 4-minute heart healthy dietary advice

Intervention Type: OTHER

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

Individually tailored diet counseling

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

Group Type: EXPERIMENTAL

Individually tailored diet counseling

Intervention Type: OTHER

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

Interventions

Individually tailored diet counseling

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

Intervention Type: OTHER

The brief standardized 4-minute heart healthy dietary advice

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Umeå

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Diakonhjemmet Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anne Grete Semb, MD, PhD

Role: CONTACT

a-semb@diakonsyk.no

+47 22 45 15 00

Facility Contacts

Anne Grete Semb, MD, PhD

Role: primary

a-semb@diakonsyk.no

22 45 15 00

Other Identifiers

Protocol 03 02 23

Identifier Type: -

Identifier Source: org_study_id