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

Primary Purpose

Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Individually tailored diet counseling
The brief standardized 4-minute heart healthy dietary advice
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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: Heart failure with systolic EF<40% Kidney failure with GFR < 35 Liver failure Mental disorder rendering the patient unable to comply with the protocol Being able to speak the language of the country Reduced cognitive function Substance abuse

Sites / Locations

  • Diakonhjemmet HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Brief standardized dietary advice

Individually tailored diet counseling

Arm Description

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

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

Outcomes

Primary Outcome Measures

LDL cholesterol change from baseline
LDL cholesterol change from baseline

Secondary Outcome Measures

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.

Full Information

First Posted
March 6, 2023
Last Updated
March 17, 2023
Sponsor
Diakonhjemmet Hospital
Collaborators
University Hospital, Umeå, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05772325
Brief Title
The Effect of Brief Versus Individually Tailored Dietary Advice on Change in Lipids, Blood Pressure, and Diet in Patients With Inflammatory Joint Disease
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"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
University Hospital, Umeå, Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief standardized dietary advice
Arm Type
Active Comparator
Arm Description
The brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists.
Arm Title
Individually tailored diet counseling
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian.
Intervention Type
Other
Intervention Name(s)
Individually tailored diet counseling
Intervention Description
Participants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian
Intervention Type
Other
Intervention Name(s)
The brief standardized 4-minute heart healthy dietary advice
Intervention Description
The brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists
Primary Outcome Measure Information:
Title
LDL cholesterol change from baseline
Description
LDL cholesterol change from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Healthy Diet Score (HDS) according to SmartDiet score
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Heart failure with systolic EF<40% Kidney failure with GFR < 35 Liver failure Mental disorder rendering the patient unable to comply with the protocol Being able to speak the language of the country Reduced cognitive function Substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Grete Semb, MD, PhD
Phone
+47 22 45 15 00
Email
a-semb@diakonsyk.no
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Grete Semb, MD, PhD
Phone
22 45 15 00
Email
a-semb@diakonsyk.no

12. IPD Sharing Statement

Plan to Share IPD
No

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

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