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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

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE March 19, 2018
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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
  • 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*
  • Changes in fruit and vegetables intake [ Time Frame: 12-weeks ]
    servings/day
  • Changes in red and processed meats intake [ Time Frame: 12-weeks ]
    servings/week
  • Changes in sugar and sweetened beverages [ Time Frame: 12-weeks ]
    servings/week
  • Changes in nut consumption [ Time Frame: 12-weeks ]
    servings week
  • changes in alcohol consumption [ Time Frame: 12-weeks ]
    g/day
  • changes in cereal fiber [ Time Frame: 12-weeks ]
    g/day
  • changes in body mass index [ Time Frame: 12-weeks ]
    kg/m2
  • Changes in physical activity [ Time Frame: 12-weeks ]
    hours per week
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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 [ Time Frame: 12-weeks ]
    mmHg
  • Changes in diastolic blood pressure [ Time Frame: 12-weeks ]
    mmHg
  • changes in percentage of body fat [ Time Frame: 12-weeks ]
  • changes in body weight [ Time Frame: 12-weeks ]
    pounds/kg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Heart Score Intervention In the Primary Care Setting
Official Title  ICMJE Assessing the Healthy Heart Score Intervention In the Primary Care Setting as a Primordial Prevention Tool
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Healthy Heart Score
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mercedes Sotos Prieto, PhD 740.593.9943 sotospri@ohio.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03482427
Other Study ID Numbers  ICMJE 18-X-35
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mercedes Sotos Prieto, PhD, Ohio University
Study Sponsor  ICMJE Ohio University
Collaborators  ICMJE OhioHealth
Investigators  ICMJE
Principal Investigator: Mercedes Sotos Prieto, PhD Ohio University
PRS Account Ohio University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP