Healthy Heart Score Intervention In the Primary Care Setting

Cardiovascular Diseases Clinical Trial

Official title:

Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03482427
• Other study ID #: 18-X-35
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 22, 2018
• Start date: March 19, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2018
• Source: Ohio University
• Contact: Mercedes Sotos Prieto, PhD
• Phone: 740.593.9943
• Email: sotospri[@]ohio.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	OhioHealth Dublin Methodist Hospital	Dublin	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12-weeks
Primary	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*	12-weeks
Primary	Changes in fruit and vegetables intake	servings/day	12-weeks
Primary	Changes in red and processed meats intake	servings/week	12-weeks
Primary	Changes in sugar and sweetened beverages	servings/week	12-weeks
Primary	Changes in nut consumption	servings week	12-weeks
Primary	changes in alcohol consumption	g/day	12-weeks
Primary	changes in cereal fiber	g/day	12-weeks
Primary	changes in body mass index	kg/m2	12-weeks
Primary	Changes in physical activity	hours per week	12-weeks
Secondary	Changes in total cholesterol levels		12-weeks
Secondary	Changes in triglycerides levels		12-weeks
Secondary	Changes in Low Density Protein levels		12-weeks
Secondary	Changes in High Density Protein levels		12-weeks
Secondary	Changes in Hemoglobin glycosylated levels		12- weeks
Secondary	Changes in systolic blood pressure	mmHg	12-weeks
Secondary	Changes in diastolic blood pressure	mmHg	12-weeks
Secondary	changes in percentage of body fat		12-weeks
Secondary	changes in body weight	pounds/kg	12-weeks