Clinical trial NCT05322876: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Keywords: Metabolic Syndrome
Cardiovascular Disease Risk Factors
Community Intervention
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: Fitbit LLC
First posted: 2022-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sample
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Efficacy of program through changes in physical health - Daily Steps
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Physical Activity
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Blood Pressure
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Lab Value -Lipid Profile
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Lab Value - Triglycerides
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Lab Value - Blood Glucose
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Waist Circumference
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Body Composition - Muscle Mass
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Body Composition - Fat Mass
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Body Fat Percentage
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in physical health - Visceral Fat Rating
timeFrame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
measure: Efficacy of program through changes in health knowledge
timeFrame: Baseline, post-6 week class series, 3- and 6-month follow-up appointments.
Secondary outcomes:
measure: Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
timeFrame: These variables will be measured and assessed throughout the full 6 month program.
measure: Adherence to program and utilization of additional resources - Fitbit Utilization
timeFrame: These variables will be measured and assessed throughout the full 6 month program.
measure: Adherence to program and utilization of additional resources - Resource Utilization
timeFrame: These variables will be measured and assessed throughout the full 6 month program.
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: University of Colorado Health
name: Victoria Bandera, MS
role: PRINCIPAL_INVESTIGATOR
References: