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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Diseases, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Healthy Hearts Family Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Sample
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Hearts Family Program<br>Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program. | Behavioral: Healthy Hearts Family Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of program through changes in physical health - Daily Steps | Physical activity metrics (daily average steps per month) measured by Fitbit devices | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Physical Activity | Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Blood Pressure | Biometric variables (blood pressure in mmHg) | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Lab Value -Lipid Profile | Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Lab Value - Triglycerides | Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Lab Value - Blood Glucose | Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Waist Circumference | Body composition (waist circumference in inches) | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Body Composition - Muscle Mass | Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Body Composition - Fat Mass | Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Body Fat Percentage | Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in physical health - Visceral Fat Rating | Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | 
| Efficacy of program through changes in health knowledge | 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. | Baseline, post-6 week class series, 3- and 6-month follow-up appointments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended | 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. | These variables will be measured and assessed throughout the full 6 month program. | 
| Adherence to program and utilization of additional resources - Fitbit Utilization | 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. | These variables will be measured and assessed throughout the full 6 month program. | 
| Adherence to program and utilization of additional resources - Resource Utilization | 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. | These variables will be measured and assessed throughout the full 6 month program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Cardiovascular Disease Risk Factors, Community Intervention