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

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"

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis
• Intervention / Treatment: Other: The brief standardized 4-minute heart healthy dietary advice; Other: Individually tailored diet counseling

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Grete Semb, MD, PhD; Phone Number: +47 22 45 15 00; Email: a-semb@diakonsyk.no

Study Locations

• Norway
  • Oslo, Norway, 0370
    • Recruiting
    • Diakonhjemmet Hospital
    • Contact: Anne Grete Semb, MD, PhD; Phone Number: 22 45 15 00; Email: a-semb@diakonsyk.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brief standardized dietary advice; The brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists.	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
Experimental: Individually tailored diet counseling; Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian.	Other: Individually tailored diet counseling; Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL cholesterol change from baseline	LDL cholesterol change from baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Aarhus University Hospital; University Hospital, Umeå

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Arthritis; Joint Diseases; Arthritis, Psoriatic; Spondylitis; Spondylarthritis
• Other Study ID Numbers: Protocol 03 02 23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No