Recruiting

Observational Study

Sponsor:

Ohio University

Code:

NCT03482427

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Healthy Heart Score

Study Details

Brief summary:

In this pilot study, the investigators will assess the clinical utility and feasibility of the Healthy Heart Score in the primary clinical care setting for the primordial prevention of cardiovascular disease. The investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim is to include 100 participants (50 in each group). Each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Conditions

Cardiovascular Diseases

Study ID

NCT03482427

Start date

Mar 19, 2018

Status verified date

Mar, 2018

Completion date

Apr 30, 2019

Anticipated

Primary completion date

Dec 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older, No cardiovascular diagnosis, Body Mass Index > 25 and/or having at least one of the following clinical risk factors: elevated blood pressure, pre-high cholesterol, pre-diabetes but not currently taking medications for the previous conditions.

Exclusion Criteria:

  • Those not meeting the inclusion criteria and women who are pregnant or planning to get pregnant.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

After completion of the Healthy Hear Score assessment, participants will receive a lifestyle intervention based on the Healthy Heart Score results for 12-weeks by trained dietetic interns on-site. Participants will receive a check-in email or phone 6 weeks after the initial visit. A Registered Dietitian is also available to speak with patients. The intervention will consist on educational materials based on each component of the Healthy Heart Score and other lifestyle behaviors

no intervention: Control

Participants in the control group will follow their usual care protocol after taking the Healthy Heart Score assessment. Researchers will provide the Healthy Heart Score survey results, but will not discuss or interpret the results with them. Participants can discuss any concern they have with their usual physician if they choose. After the follow-up visit and upon completion of the study, all participants in the control group may also receive the educational handouts and will be granted access to the Healthy Heart Score application if they wish.

Interventions

Healthy Heart Score

Educational materials based on each component of the Healthy Heart Score and other lifestyle behaviors will be provided to the participants that include the following topics: Fruit and vegetable consumption, Whole grain consumption/ limiting refined grains, Healthy protein choices, Healthy dietary fats, Limiting Sugar-sweetened beverages, Importance of physical activity, Proper hydration, Stress management, Adequate Sleep, Smoking Cessation, Weekly menu example, Recipe Cards following the Mediterranean diet principals, Interactive weekly checklist to encourage participants to meet their weekly goals for consumption of fruits, vegetable, nuts and seeds. Participants will receive a check-in email or phone 6 weeks after the baseline visit. A Registered Dietitian is also available to speak with patients.

Primary outcome measure

  • Changes in the overall Healthy Heart Score risk score [ Time Frame: 12-weeks ]
  • Changes in the overall composite of diet [ Time Frame: 12-weeks ]
  • Changes in fruit and vegetables intake [ Time Frame: 12-weeks ]
  • Changes in red and processed meats intake [ Time Frame: 12-weeks ]
  • Changes in sugar and sweetened beverages [ Time Frame: 12-weeks ]
  • Changes in nut consumption [ Time Frame: 12-weeks ]
  • changes in alcohol consumption [ Time Frame: 12-weeks ]
  • changes in cereal fiber [ Time Frame: 12-weeks ]
  • changes in body mass index [ Time Frame: 12-weeks ]
  • Changes in physical activity [ Time Frame: 12-weeks ]

Central Contacts and Locations

Central contacts

Mercedes Sotos Prieto, PhD

740.593.9943sotospri@ohio.edu

Locations

OhioHealth Dublin Methodist Hospital

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Matthew Kunar, DO

Matt.Kunar@ohiohealth.com

More Information

Sponsor

Ohio University

Last update posted

Mar 29, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio University on 2018-03-29.