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Clinical Trials/NCT05322876
NCT05322876
Recruiting
Not Applicable

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

Poudre Valley Health System1 site in 1 country80 target enrollmentMarch 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Poudre Valley Health System
Enrollment
80
Locations
1
Primary Endpoint
Efficacy of program through changes in physical health - Lab Value - Blood Glucose
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gary J. Luckasen, MD

Principal Investigator

Poudre Valley Health System

Eligibility 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

Outcomes

Primary Outcomes

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

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)

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

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

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

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.

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

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.

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)

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.

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.

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 Outcomes

  • Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended(These variables will be measured and assessed throughout the full 6 month program.)
  • Adherence to program and utilization of additional resources - Resource Utilization(These variables will be measured and assessed throughout the full 6 month program.)
  • Adherence to program and utilization of additional resources - Fitbit Utilization(These variables will be measured and assessed throughout the full 6 month program.)

Study Sites (1)

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