Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Efficacy of program through changes in physical health - Lab Value - Blood Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one member of the family unit self-identifies as Hispanic
- •At least 13 years of age
排除标准
- •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
结局指标
主要结局
Efficacy of program through changes in physical health - Lab Value - Blood Glucose
时间窗: 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
Efficacy of program through changes in physical health - Waist Circumference
时间窗: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (waist circumference in inches)
Efficacy of program through changes in physical health - Daily Steps
时间窗: 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
Efficacy of program through changes in physical health - Physical Activity
时间窗: 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
Efficacy of program through changes in physical health - Lab Value - Triglycerides
时间窗: 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
Efficacy of program through changes in physical health - Body Fat Percentage
时间窗: 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.
Efficacy of program through changes in physical health - Lab Value -Lipid Profile
时间窗: 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
Efficacy of program through changes in physical health - Body Composition - Fat Mass
时间窗: 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.
Efficacy of program through changes in physical health - Blood Pressure
时间窗: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Biometric variables (blood pressure in mmHg)
Efficacy of program through changes in physical health - Body Composition - Muscle Mass
时间窗: 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.
Efficacy of program through changes in physical health - Visceral Fat Rating
时间窗: 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.
Efficacy of program through changes in health knowledge
时间窗: 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.
次要结局
- Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended(These variables will be measured and assessed throughout the full 6 month program.)
- Adherence to program and utilization of additional resources - Resource Utilization(These variables will be measured and assessed throughout the full 6 month program.)
- Adherence to program and utilization of additional resources - Fitbit Utilization(These variables will be measured and assessed throughout the full 6 month program.)
研究者
Gary J. Luckasen, MD
Principal Investigator
Poudre Valley Health System