Recruiting

Community Intervention

Sponsor:

Poudre Valley Health System

Code:

NCT05322876

Conditions

Cardiovascular Diseases

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

Healthy Hearts Family Program

Study Details

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

Study ID

NCT05322876

Start date

Mar 22, 2022

Status verified date

Apr, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Healthy Hearts Family Program

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

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Efficacy of program through changes in health knowledge [ Time Frame: Baseline, post-6 week class series, 3- and 6-month follow-up appointments. ]

Central Contacts and Locations

Central contacts

Victoria M Bandera, MS

7329913081victoria.bandera@uchealth.org

NaNet Jenkins, MPH

9706245298nanet.jenkins@uchealth.org

Locations

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80528

Contacts

NaNet Jenkins, MPH, MHSA

970-624-5298nanet.jenkins@uchealth.org

More Information

Sponsor

Poudre Valley Health System

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Metabolic Syndrome
  • Cardiovascular Disease Risk Factors
  • Community Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Poudre Valley Health System on 2024-04-03.