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

NCT05322876 | Recruiting

• 1 other identifier: HHFP-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Keywords

Metabolic Syndrome; Cardiovascular Disease Risk Factors; Community Intervention

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• 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 - Fitbit Utilization

  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.

Study Arms (1)

Healthy Hearts Family Program

EXPERIMENTAL

Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.

Behavioral: Healthy Hearts Family Program

Interventions

Healthy Hearts Family Program BEHAVIORAL

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.

Healthy Hearts Family Program

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poudre Valley Health System: lead
• Fitbit LLC: collaborator

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80528, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Victoria Bandera, MS

  University of Colorado Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria M Bandera, MS

CONTACT

7329913081; victoria.bandera@uchealth.org

NaNet Jenkins, MPH

CONTACT

9706245298; nanet.jenkins@uchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sample

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: April 12, 2022
• Study Start: March 22, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)