Healthy Heart Score Intervention In the Primary Care Setting

NCT03482427 | Unknown

• 1 other identifier: 18-X-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Changes in fruit and vegetables intake

  servings/day

  12-weeks

• Changes in red and processed meats intake

  servings/week

  12-weeks

• Changes in sugar and sweetened beverages

  servings/week

  12-weeks

• Changes in nut consumption

  servings week

  12-weeks

• changes in alcohol consumption

  g/day

  12-weeks

• changes in cereal fiber

  g/day

  12-weeks

• changes in body mass index

  kg/m2

  12-weeks

• Changes in physical activity

  hours per week

  12-weeks

Secondary Outcomes (9)

• 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 Hemoglobin glycosylated levels

  12- weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Healthy Heart Score

Control

NO INTERVENTION

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 BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ohio University: lead
• OhioHealth: collaborator

Study Sites (1)

OhioHealth Dublin Methodist Hospital

Dublin, Ohio, 43016, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mercedes Sotos Prieto, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mercedes Sotos Prieto, PhD

CONTACT

740.593.9943; sotospri@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will test our intervention compared to usual care (control)

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 29, 2018
• Study Start: March 19, 2018
• Primary Completion: December 30, 2018
• Study Completion: April 30, 2019
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)