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NCT Number: NCT05772325

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

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Recent initiation or change in doses of lipid-lowering therapy or weight loss medication

Treatment and study plan

Individually tailored diet counseling

Other

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

Other

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

Primary outcomes

  1. LDL cholesterol change from baseline

    Time frame: 8 weeks

    LDL cholesterol change from baseline

Secondary outcomes

  1. Change in Healthy Diet Score (HDS) according to SmartDiet score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • University Hospital, Umeå

Registry information

Official study 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"

Acronym: BETTER Diet

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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