Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Fruit and Vegetable Intake
研究概览
简要总结
The purpose of this study is to evaluate the web tool #HerHeart's usability and feasibility in adolescent and young adult women (AYA) and the opinion of their healthcare providers (HCP).
详细描述
The objective of the proposed research is to increase young women's perceived susceptibility to CVD and provide a cue to action to adopt heart-healthy behaviors. The aim of the proposed study is to evaluate the usability and initial feasibility of #HerHeart. The investigators will recruit 30 AYA participants and will ask 10 HCPs to evaluate the usability and feasibility of the web tool.
The study population will include female patients ages 13-21 years from the CHOA Adolescent Medicine Practice and Grady Teen Health Program. Part of our study population will be considered vulnerable (children under the age of 18 years). Subjects will be recruited via phone in advance of a clinical visit, from the waiting rooms of each clinic at the time of their appointment (in-person) or via Zoom at a time scheduled after their telehealth appointment (virtual). Written informed consent will be obtained for subjects 18 years and older. For subjects younger than 18 years, written parental permission (unless doing so would violate the adolescents' right to privacy, in which the Waiver of Parental Permission will be invoked) and written informed assent will be obtained. All consent procedures will take place in a private research room of each clinic (for in-person visits) or via Zoom videoconferencing (for virtual visits). Participants who agree to participate will attend a study visit at the Emory Children's Center Research Unit.
Data for this study will be collected from participants via surveys/questionnaires, and semi-structured interviews that will be audio-recorded. Data collected will include demographic information, cardiovascular disease risk information, health metrics (BMI, blood pressure), cognitive data (perceived stress, quality of life), and participant feedback on a mobile app intervention. All subjects will receive a study identification number. Only the PI will have the codes linking the study identification numbers to subjects and these codes will be stored in a locked cabinet. All data will be collected in a private research room in the clinics (in-person visits) or in a password-protected Zoom videoconference (virtual). All study staff will complete biomedical or socio-behavioral training through the Collaborative IRB Training Initiative Program (CITI). Data will be stored on the Emory servers in password-protected files.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fruit and Vegetable Intake
时间窗: Baseline, 3 months post- post-enrollment
Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.
Red and Processed Meats Intake
时间窗: Baseline, 3 months post-enrollment
Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome.
Alcohol Consumption
时间窗: Baseline, 3 months post-enrollment
Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.
Nicotine Use
时间窗: Baseline, 3 months post-enrollment
Self-reported smoker status will be obtained and classified as: Never smoke, used to smoke, current smoker. Investigators will look at changes in smoking status where a decrease in use is associated with a better outcome.
Nut Consumption
时间窗: Baseline, 3 months post-intervention
Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.
Cereal Fiber
时间窗: Baseline, 3 months post-enrollment
Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.
#HerHEART Risk Score in AYA From Baseline
时间窗: Baseline, 3 months post-enrollment
Risk is assessed based on answers surrounding the most critical diet and lifestyle factors that can influence a person's CVD risk. The factors include exercise, intake of fruits, vegetables, grains, nuts, sugary beverages and red/processed meats, and exercise. The Healthy Heart Score algorithm will be used to calculate the relative percent risk score of participants. Participants with a higher percent risk score have a higher risk for CVD based on their current reported habits. Those at low risk will have a risk score \<10%, moderate risk a risk score between 10 and 15%, and high risk a score above 15%.
Sugar and Sweetened Beverages
时间窗: Baseline, 3 months post-enrollment
Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.
Physical Activity
时间窗: Baseline, 3 months post-enrollment
Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.
Overall Composite of Diet Score
时间窗: Baseline, 3 months months post-enrollment
Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 \[if fruits + vegetables ≥3 servings/d\] + 0.14522 \[if nuts 0.1-1 servings/d + 0.2444 \[if nuts \>1 servings/d\]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)\*10 A higher score implies better diet quality. An increase in diet score correlates with a better outcome.
次要结局
- BMI From Baseline(Baseline, 3 month post-enrollment)
- Systolic Blood Pressure (BP) From Baseline(Baseline, 3 month post-enrollment)
- Diastolic Blood Pressure (BP) From Baseline(Baseline, 3 month post-enrollment)
研究者
Holly Gooding
Associate Professor
Emory University