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Healthy Heart Score Intervention In the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT03482427
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
OhioHealth
Information provided by (Responsible Party):
Mercedes Sotos Prieto, PhD, Ohio University

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).

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Healthy Heart Score Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will test our intervention compared to usual care (control)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : April 30, 2019

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
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.

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.



Primary Outcome Measures :
  1. 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


  2. 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*


  3. Changes in fruit and vegetables intake [ Time Frame: 12-weeks ]
    servings/day

  4. Changes in red and processed meats intake [ Time Frame: 12-weeks ]
    servings/week

  5. Changes in sugar and sweetened beverages [ Time Frame: 12-weeks ]
    servings/week

  6. Changes in nut consumption [ Time Frame: 12-weeks ]
    servings week

  7. changes in alcohol consumption [ Time Frame: 12-weeks ]
    g/day

  8. changes in cereal fiber [ Time Frame: 12-weeks ]
    g/day

  9. changes in body mass index [ Time Frame: 12-weeks ]
    kg/m2

  10. Changes in physical activity [ Time Frame: 12-weeks ]
    hours per week


Secondary Outcome Measures :
  1. Changes in total cholesterol levels [ Time Frame: 12-weeks ]
  2. Changes in triglycerides levels [ Time Frame: 12-weeks ]
  3. Changes in Low Density Protein levels [ Time Frame: 12-weeks ]
  4. Changes in High Density Protein levels [ Time Frame: 12-weeks ]
  5. Changes in Hemoglobin glycosylated levels [ Time Frame: 12- weeks ]
  6. Changes in systolic blood pressure [ Time Frame: 12-weeks ]
    mmHg

  7. Changes in diastolic blood pressure [ Time Frame: 12-weeks ]
    mmHg

  8. changes in percentage of body fat [ Time Frame: 12-weeks ]
  9. changes in body weight [ Time Frame: 12-weeks ]
    pounds/kg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482427


Contacts
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Contact: Mercedes Sotos Prieto, PhD 740.593.9943 sotospri@ohio.edu

Locations
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United States, Ohio
OhioHealth Dublin Methodist Hospital Recruiting
Dublin, Ohio, United States, 43016
Contact: Matthew Kunar, DO       Matt.Kunar@ohiohealth.com   
Sponsors and Collaborators
Ohio University
OhioHealth
Investigators
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Principal Investigator: Mercedes Sotos Prieto, PhD Ohio University

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Responsible Party: Mercedes Sotos Prieto, PhD, Assistant Professor, Ohio University
ClinicalTrials.gov Identifier: NCT03482427     History of Changes
Other Study ID Numbers: 18-X-35
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases