Healthy Heart Score Intervention In the Primary Care Setting

Ohio University100 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Cardiovascular Diseases

Interventions

Healthy Heart ScoreBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

OhioHealth Dublin Methodist Hospital

Dublin, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Changes in the overall Healthy Heart Score risk score

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

Time frame: 12-weeks

Changes in the overall composite of diet

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\*

Time frame: 12-weeks

Changes in fruit and vegetables intake

servings/day

Time frame: 12-weeks

Changes in red and processed meats intake

servings/week

Time frame: 12-weeks

Changes in sugar and sweetened beverages

Central Contacts

Mercedes Sotos Prieto, PhD

CONTACT

740.593.9943 sotospri@ohio.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Changes in total cholesterol levels

Time frame: 12-weeks

Changes in triglycerides levels

Time frame: 12-weeks

Changes in Low Density Protein levels

Time frame: 12-weeks

Changes in High Density Protein levels

Time frame: 12-weeks

Changes in Hemoglobin glycosylated levels

Time frame: 12- weeks

Changes in systolic blood pressure

mmHg

Time frame: 12-weeks

Changes in diastolic blood pressure

mmHg

Time frame: 12-weeks

changes in percentage of body fat

Time frame: 12-weeks

changes in body weight

pounds/kg

Time frame: 12-weeks