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Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05322876
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Collaborators:
Fitbit Inc
Small Steps Labs, LLC
Information provided by (Responsible Party):
Victoria Bandera, Poudre Valley Health System

Study Description
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Brief Summary:
The purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in Hispanic families in northern Colorado as measured through biometric screenings, body composition, physical activity, and health knowledge.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Syndrome Behavioral: Healthy Hearts Family Program Not Applicable

Detailed Description:
The current project aims to leverage the UCHealth Healthy Hearts Family Program to provide a free, non-insurance-based 1-year cardiovascular disease (CVD) prevention and wellness program to Hispanic Colorado families. This program includes an interactive educational class series, baseline and quarterly biometric screenings, and optional consultations with an Exercise Physiologist and a Dietitian. This program takes a novel approach to preventative care by incorporating the family unit with the intention of having the child be the agent of change. The long-term goals of this project are to significantly improve CVD risk factors among participating families and to disseminate study findings to inform developing and current outreach programs to offer effective CVD prevention programs for Hispanic citizens. This work may ultimately lead to more Hispanics being served through new or existing programs, therefore expanding important preventative community health interventions into this underserved population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sample
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
Actual Study Start Date : March 22, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy Hearts Family Program
Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.
 Behavioral: Healthy Hearts Family Program
Participants will participate in a baseline health and knowledge screening, followed by a 6-week once-weekly class series, and 3- and 6-month follow-up health and knowledge screenings.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of program through changes in physical health - Daily Steps [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Physical activity metrics (daily average steps per month) measured by Fitbit devices

  2. Efficacy of program through changes in physical health - Physical Activity [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices

  3. Efficacy of program through changes in physical health - Blood Pressure [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Biometric variables (blood pressure in mmHg)

  4. Efficacy of program through changes in physical health - Lab Value -Lipid Profile [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling

  5. Efficacy of program through changes in physical health - Lab Value - Triglycerides [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling

  6. Efficacy of program through changes in physical health - Lab Value - Blood Glucose [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling

  7. Efficacy of program through changes in physical health - Waist Circumference [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Body composition (waist circumference in inches)

  8. Efficacy of program through changes in physical health - Body Composition - Muscle Mass [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  9. Efficacy of program through changes in physical health - Body Composition - Fat Mass [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  10. Efficacy of program through changes in physical health - Body Fat Percentage [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  11. Efficacy of program through changes in physical health - Visceral Fat Rating [ Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared ]
    Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  12. Efficacy of program through changes in health knowledge [ Time Frame: Baseline, post-6 week class series, 3- and 6-month follow-up appointments. ]
    Health knowledge gained and retained will be evaluated and compared at baseline, post-6 week class series, 3- and 6-month follow-ups utilizing previously developed and utilized Healthy Hearts knowledge survey. This outcome will be measured by correct responses on the Healthy Hearts knowledge survey.


Secondary Outcome Measures :
  1. Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended [ Time Frame: These variables will be measured and assessed throughout the full 6 month program. ]
    Attendance for screenings, classes and other consultations across baseline and follow-up visits. Attendance will be measured as the percentage of scheduled visits (including the 6 week class series and the 3- and 6-month follow-up visits) completed.

  2. Adherence to program and utilization of additional resources - Fitbit Utilization [ Time Frame: These variables will be measured and assessed throughout the full 6 month program. ]
    Compliance to Fitbit utilization as measured by days worn throughout the 6 month program. The NHANES compliance to wear time of > 10 hours worn per day will be utilized.

  3. Adherence to program and utilization of additional resources - Resource Utilization [ Time Frame: These variables will be measured and assessed throughout the full 6 month program. ]
    Use of Exercise Physiologist and Dietician resources provided will be quantified and reported. This outcome will be reported as the number of consultation appointments requested and utilized throughout the program.


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one member of the family unit self-identifies as Hispanic
  • At least 13 years of age

Exclusion Criteria:

  • Unwilling to wear Fitbit devices daily for 6 months except when charging and sleeping
  • Cannot read or understand either English or Spanish
  • Cannot return to screening location to perform the minimum of the baseline, 3-month and 6-month follow-up screenings
  • Children or adolescents will be excluded from this project without a minimum of one accompanying parent or guardian
Contacts and Locations
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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): NCT05322876


Contacts
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Contact: Victoria M Bandera, MS 7329913081 victoria.bandera@uchealth.org
Contact: NaNet Jenkins, MPH 9706245298 nanet.jenkins@uchealth.org

Locations
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United States, Colorado
Medical Center of the Rockies Recruiting
Loveland, Colorado, United States, 80528
Contact: NaNet Jenkins, MPH, MHSA    970-624-5298    nanet.jenkins@uchealth.org   
Sponsors and Collaborators
Poudre Valley Health System
Fitbit Inc
Small Steps Labs, LLC
Investigators
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Principal Investigator: Victoria Bandera, MS University of Colorado Health
More Information
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Responsible Party: Victoria Bandera, Principal Investigator, Poudre Valley Health System
ClinicalTrials.gov Identifier: NCT05322876    
Other Study ID Numbers: HHFP-001
First Posted: April 12, 2022    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victoria Bandera, Poudre Valley Health System:
Metabolic Syndrome
Cardiovascular Disease Risk Factors
Community Intervention
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases