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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Healthy Hearts Family Program

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria M Bandera, MS; Phone Number: 7329913081; Email: victoria.bandera@uchealth.org
• Study Contact Backup: Name: NaNet Jenkins, MPH; Phone Number: 9706245298; Email: nanet.jenkins@uchealth.org

Study Locations

• United States
  • Colorado
    • Loveland, Colorado, United States, 80528
      • Recruiting
      • Medical Center of the Rockies
      • Contact: NaNet Jenkins, MPH, MHSA; Phone Number: 970-624-5298; Email: nanet.jenkins@uchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Poudre Valley Health System
• Collaborators: Fitbit LLC
• Investigators: Principal Investigator: Victoria Bandera, MS, University of Colorado Health

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Community Intervention; Cardiovascular Disease Risk Factors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: HHFP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No