An interventional study of Individually tailored diet counseling and The brief standardized 4-minute heart healthy dietary advice in Rheumatoid Arthritis, Psoriatic Arthritis and Spondyloarthritis, sponsored by Diakonhjemmet Hospital. Active, not recruiting at 1 site in Norway. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Prevention
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.
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.
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This study's planned enrollment of 70 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
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Exclusion Criteria:
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
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
The brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists
LDL cholesterol change from baseline
LDL cholesterol change from baseline
Time frame: 8 weeks
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Diakonhjemmet Hospital