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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322876
• Other study ID #: HHFP-001
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Poudre Valley Health System
• Contact: Victoria M Bandera, MS
• Phone: 7329913081
• Email: victoria.bandera[@]uchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Poudre Valley Health System	Fitbit LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.