Diakonhjemmet Hospital
Oslo, 0370, Norway
NCT Number: NCT05772325
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.
This study is active but is not currently recruiting participants.
Notify Me30 year–80 year
All sexes
Interventional
Not applicable
Oslo, 0370, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 8 weeks
LDL cholesterol change from baseline
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.
Diakonhjemmet Hospital
Other
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
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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