Cardiovascular Diseases Clinical Trial
Official title:
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical Center of the Rockies | Loveland | Colorado |
Lead Sponsor | Collaborator |
---|---|
Poudre Valley Health System | Fitbit LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of program through changes in physical health - Daily Steps | 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 | |
Primary | 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 | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | Efficacy of program through changes in physical health - Blood Pressure | Biometric variables (blood pressure in mmHg) | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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 | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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 | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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 | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | Efficacy of program through changes in physical health - Waist Circumference | Body composition (waist circumference in inches) | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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. | Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared | |
Primary | 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. | Baseline, post-6 week class series, 3- and 6-month follow-up appointments. | |
Secondary | 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. | These variables will be measured and assessed throughout the full 6 month program. | |
Secondary | 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. | These variables will be measured and assessed throughout the full 6 month program. | |
Secondary | 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. | These variables will be measured and assessed throughout the full 6 month program. |
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