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

April 1, 2024 updated by: Gary J. Luckasen, MD, Poudre Valley Health System
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Loveland, Colorado, United States, 80528
        • Recruiting
        • Medical Center of the Rockies
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
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
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
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
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
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
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
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
Time Frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
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
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.
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
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.
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
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.
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
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.
Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
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.
Baseline, post-6 week class series, 3- and 6-month follow-up appointments.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
Time Frame: These variables will be measured and assessed throughout the full 6 month program.
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
Time Frame: These variables will be measured and assessed throughout the full 6 month program.
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
Time Frame: These variables will be measured and assessed throughout the full 6 month program.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poudre Valley Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fitbit LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria Bandera, MS, University of Colorado Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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