Cardiovascular Diseases
Conditions
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).
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).
Interventions
BEHAVIORALHealthy 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.
Sponsors
OhioHealth
Ohio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
We will test our intervention compared to usual care (control)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in physical activity | 12-weeks | hours per week |
| Changes in the overall Healthy Heart Score risk score | 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 |
| Changes in the overall composite of diet | 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\* |
| Changes in fruit and vegetables intake | 12-weeks | servings/day |
| Changes in red and processed meats intake | 12-weeks | servings/week |
| Changes in sugar and sweetened beverages | 12-weeks | servings/week |
| Changes in nut consumption | 12-weeks | servings week |
| changes in alcohol consumption | 12-weeks | g/day |
| changes in cereal fiber | 12-weeks | g/day |
| changes in body mass index | 12-weeks | kg/m2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in systolic blood pressure | 12-weeks | mmHg |
| Changes in diastolic blood pressure | 12-weeks | mmHg |
| Changes in total cholesterol levels | 12-weeks | — |
| Changes in triglycerides levels | 12-weeks | — |
| Changes in Low Density Protein levels | 12-weeks | — |
| Changes in High Density Protein levels | 12-weeks | — |
| changes in percentage of body fat | 12-weeks | — |
| changes in body weight | 12-weeks | pounds/kg |
| Changes in Hemoglobin glycosylated levels | 12- weeks | — |
Countries
United States
Contacts
Primary ContactMercedes Sotos Prieto, PhD
Outcome results
None listed