Status:
COMPLETED
The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
University College Dublin
Harvard School of Public Health (HSPH)
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is a a randomized controlled parallel group dietary intervention conducted over six months in participants at high risk of cardiovascular disease living in Ireland (North and South) to eval...
Detailed Description
Study design: a randomized controlled parallel group dietary intervention will be conducted over six months in participants at high risk of CVD living in Ireland (North and South) to evaluate the effi...
Eligibility Criteria
Inclusion
- Participants will be at high risk (\>20% over 10 years) of developing CVD.
- Participants will be considered eligible to enroll in the study if they are:
- overweight (BMI \>27 and ≤ 45 kg/m2),
- have low Prime Diet Quality Score (PDQS \<15) and
- have a combination of risk factors which places them at high total risk (estimated multifactorial CVD risk ≥ 20% over ten years) of developing atherosclerotic CVD for the first time.
Exclusion
- Participants will be ineligible to enroll in the study if they have:
- established diabetes mellitus, CVD or a medical condition or dietary restriction(s) that would substantially limit their ability to complete the study requirements,
- have an excessive alcohol consumption (\>28 Units/week for men or \>21 Units/week for women),
- have a low predicted likelihood to change dietary habits
- are unable to provide informed consent.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03854461
Start Date
January 1 2022
End Date
March 31 2024
Last Update
August 17 2025
Active Locations (1)
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1
Centre for Public Health, Institute of Clinical Sciences A, Queen's University Belfast, Grosvenor Road, Royal site. Road
Belfast, Northern Ireland, United Kingdom, BT12 6BA