The Effect of Brief Versus Individually Tailored Dietary Advice on Change in Lipids, Blood Pressure, and Diet in Patients With Inflammatory Joint Disease
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2023
CompletedFirst Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedMarch 20, 2023
March 1, 2023
1.5 years
March 6, 2023
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
LDL cholesterol change from baseline
LDL cholesterol change from baseline
8 weeks
Secondary Outcomes (1)
Change in Healthy Diet Score (HDS) according to SmartDiet score
8 weeks
Study Arms (2)
Brief standardized dietary advice
ACTIVE COMPARATORThe brief standardized 4-minute heart healthy dietary advice will be provided by an experienced cardiologist or rheumatologists.
Individually tailored diet counseling
EXPERIMENTALParticipants in the intervention group will receive a 60 min individually tailored heart-friendly diet consultation by a dietitian.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diakonhjemmet Hospitallead
- University Hospital, Umeåcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (1)
Diakonhjemmet Hospital
Oslo, 0370, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 16, 2023
Study Start
February 20, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
March 20, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share