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

NCT ID: NCT05322876

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sample
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Healthy Hearts Family Program

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

Group Type EXPERIMENTAL

Healthy Hearts Family Program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fitbit LLC

INDUSTRY

Sponsor Role collaborator

Poudre Valley Health System

OTHER

Sponsor Role lead

Responsible Party

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Gary J. Luckasen, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victoria Bandera, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Health

Locations

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Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria M Bandera, MS

Role: CONTACT

7329913081

NaNet Jenkins, MPH

Role: CONTACT

9706245298

Facility Contacts

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NaNet Jenkins, MPH, MHSA

Role: primary

970-624-5298

Other Identifiers

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HHFP-001

Identifier Type: -

Identifier Source: org_study_id

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