- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482427
Healthy Heart Score Intervention In the Primary Care Setting
Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Created by the Harvard T.H Chan School of Public Health, the Healthy Heart Score is a previously validated online risk calculator that determines the 20-year Cardiovascular Disease ) risk based on 9 modifiable lifestyle factors including; smoking habits, body mass index, physical activity, alcohol consumption, fruit and vegetables intake, cereal fiber, nuts, sugar-sweetened beverages, and red meat, and processed meats consumption.
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 clinical trial to test our intervention compared to usual care. 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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mercedes Sotos Prieto, PhD
- Phone Number: 740.593.9943
- Email: sotospri@ohio.edu
Study Locations
-
-
Ohio
-
Dublin, Ohio, United States, 43016
- Recruiting
- OhioHealth Dublin Methodist Hospital
-
Contact:
- Matthew Kunar, DO
- Email: Matt.Kunar@ohiohealth.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the overall Healthy Heart Score risk score
Time Frame: 12-weeks
|
The Healthy Heart Score is a lifestyle-based risk tool that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) This gender-specific algorithm has been published (DOI: 10.1161/JAHA.114.000954): 20-year CVD risk (%) "Healthy Heart Score" = [1 - 0. 9660 (exp [W- 6.57301)] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × grams/d of alcohol + 0.0004 × (grams/d of alcohol)2- 0.029251 × hours/week of physical activity - 0.05113 × diet score* 20-year CVD risk (%) "Healthy Heart Score" = [1 - 0. 96368 (exp [W-7.2437)] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × grams/d of alcohol + 0.0001 × (grams/d of alcohol)2- 0.01755 × hours/week of physical activity - 0.06691 × diet score |
12-weeks
|
Changes in the overall composite of diet
Time Frame: 12-weeks
|
women: Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 [if fruits + vegetables ≥3 servings/d] + 0.14522 [if nuts 0.1-1 servings/d + 0.2444 [if nuts >1 servings/d]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)*10 Women: Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 [if fruits + vegetables ≥3 servings/d] + 0.14522 [if nuts 0.1-1 servings/d + 0.2444 [if nuts >1 servings/d]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)*10. Men: where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × grams/d of alcohol + 0.0001 × (grams/d of alcohol)2- 0.01755 × hours/week of physical activity - 0.06691 × diet score* |
12-weeks
|
Changes in fruit and vegetables intake
Time Frame: 12-weeks
|
servings/day
|
12-weeks
|
Changes in red and processed meats intake
Time Frame: 12-weeks
|
servings/week
|
12-weeks
|
Changes in sugar and sweetened beverages
Time Frame: 12-weeks
|
servings/week
|
12-weeks
|
Changes in nut consumption
Time Frame: 12-weeks
|
servings week
|
12-weeks
|
changes in alcohol consumption
Time Frame: 12-weeks
|
g/day
|
12-weeks
|
changes in cereal fiber
Time Frame: 12-weeks
|
g/day
|
12-weeks
|
changes in body mass index
Time Frame: 12-weeks
|
kg/m2
|
12-weeks
|
Changes in physical activity
Time Frame: 12-weeks
|
hours per week
|
12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in total cholesterol levels
Time Frame: 12-weeks
|
12-weeks
|
|
Changes in triglycerides levels
Time Frame: 12-weeks
|
12-weeks
|
|
Changes in Low Density Protein levels
Time Frame: 12-weeks
|
12-weeks
|
|
Changes in High Density Protein levels
Time Frame: 12-weeks
|
12-weeks
|
|
Changes in Hemoglobin glycosylated levels
Time Frame: 12- weeks
|
12- weeks
|
|
Changes in systolic blood pressure
Time Frame: 12-weeks
|
mmHg
|
12-weeks
|
Changes in diastolic blood pressure
Time Frame: 12-weeks
|
mmHg
|
12-weeks
|
changes in percentage of body fat
Time Frame: 12-weeks
|
12-weeks
|
|
changes in body weight
Time Frame: 12-weeks
|
pounds/kg
|
12-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mercedes Sotos Prieto, PhD, Ohio University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-X-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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