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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772325
• Other study ID #: Protocol 03 02 23
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2023
• Source: Diakonhjemmet Hospital
• Contact: Anne Grete Semb, MD, PhD
• Phone: +47 22 45 15 00
• Email: a-semb[@]diakonsyk.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Joint Diseases
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Other:
• Individually tailored diet counseling
Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian
• 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

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Aarhus University Hospital, University Hospital, Umeå

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol change from baseline	LDL cholesterol change from baseline	8 weeks
Secondary	Change in Healthy Diet Score (HDS) according to SmartDiet score	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.	8 weeks