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

Not Applicable

Recruiting

• Conditions: Psoriatic Arthritis; Rheumatoid Arthritis; Spondyloarthritis
• Interventions: Other: Individually tailored diet counseling; Other: The brief standardized 4-minute heart healthy dietary advice

• Registration Number: NCT05772325
• Lead Sponsor: Diakonhjemmet Hospital

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.

Study Timeline

• Study Start: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individually tailored diet counseling	Individually tailored diet counseling	Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian.
Brief standardized dietary advice	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.

Primary Outcome Measures

Name	Time	Method
LDL cholesterol change from baseline	8 weeks	LDL cholesterol change from baseline

Secondary Outcome Measures

Name	Time	Method
Change in Healthy Diet Score (HDS) according to SmartDiet score	8 weeks	A self-administered 15-item food-frequency questionnaire (SmartDiet™) will be applied to assess subjects' average intake of: dairy products, mayonnaise products, meat, grain, fish, fruit, vegetables and snacks. The questionnaire has three response categories: Least healthy (1 point), Medium healthy (2 points) and Most healthy (3 points). The scores on the 15 questions are summed to obtain a Healthy Diet Score (HDS) ranging from 15 (worst) to 45 points (best). A change in the sum score of \> 3 is considered a (clinical) significant change in diet.

Trial Locations

Locations (1)

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway