Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
Primary Purpose
Cardiovascular Diseases, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Hearts Family Program
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Metabolic Syndrome, Cardiovascular Disease Risk Factors, Community Intervention
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
Sites / Locations
- Medical Center of the RockiesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Hearts Family Program
Arm Description
Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.
Outcomes
Primary Outcome Measures
Efficacy of program through changes in physical health - Daily Steps
Physical activity metrics (daily average steps per month) measured by Fitbit devices
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
Efficacy of program through changes in physical health - Blood Pressure
Biometric variables (blood pressure in mmHg)
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
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
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
Efficacy of program through changes in physical health - Waist Circumference
Body composition (waist circumference in inches)
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05322876
First Posted
February 25, 2022
Last Updated
February 13, 2023
Sponsor
Poudre Valley Health System
Collaborators
Fitbit LLC, Small Steps Labs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05322876
Brief Title
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
Official Title
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poudre Valley Health System
Collaborators
Fitbit LLC, Small Steps Labs, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome
Keywords
Metabolic Syndrome, Cardiovascular Disease Risk Factors, Community Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sample
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Hearts Family Program
Arm Type
Experimental
Arm Description
Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Hearts Family Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of program through changes in physical health - Daily Steps
Description
Physical activity metrics (daily average steps per month) measured by Fitbit devices
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Physical Activity
Description
Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Blood Pressure
Description
Biometric variables (blood pressure in mmHg)
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Lab Value -Lipid Profile
Description
Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Lab Value - Triglycerides
Description
Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Lab Value - Blood Glucose
Description
Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Waist Circumference
Description
Body composition (waist circumference in inches)
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Body Composition - Muscle Mass
Description
Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Body Composition - Fat Mass
Description
Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Body Fat Percentage
Description
Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in physical health - Visceral Fat Rating
Description
Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Time Frame
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Title
Efficacy of program through changes in health knowledge
Description
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.
Time Frame
Baseline, post-6 week class series, 3- and 6-month follow-up appointments.
Secondary Outcome Measure Information:
Title
Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
Description
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.
Time Frame
These variables will be measured and assessed throughout the full 6 month program.
Title
Adherence to program and utilization of additional resources - Fitbit Utilization
Description
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.
Time Frame
These variables will be measured and assessed throughout the full 6 month program.
Title
Adherence to program and utilization of additional resources - Resource Utilization
Description
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.
Time Frame
These variables will be measured and assessed throughout the full 6 month program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria M Bandera, MS
Phone
7329913081
Email
victoria.bandera@uchealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
NaNet Jenkins, MPH
Phone
9706245298
Email
nanet.jenkins@uchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Bandera, MS
Organizational Affiliation
University of Colorado Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NaNet Jenkins, MPH, MHSA
Phone
970-624-5298
Email
nanet.jenkins@uchealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
We'll reach out to this number within 24 hrs