Incorporating CV Risk Assessment in AYA Visits
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: #HerHeart tool
- Registration Number
- NCT05384834
- Lead Sponsor
- Emory University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AYA participants #HerHeart tool AYA participants will complete a brief initial survey consisting of demographic information and the Visual Analog Scale (VAS) and the #HerHeart tool in clinic. AYA participants will the rate the usability of the #HerHeart tool using the Website Analysis and Measurement Inventory (WAMMI), the likelihood they would recommend the app to their friends, and the likelihood of behavior change. AYA participants will then be offered the opportunity to continue into the 3-month intervention phase.
- Primary Outcome Measures
Name Time Method Fruit and Vegetable Intake 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 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 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method BMI From Baseline Baseline, 3 month post-enrollment AYA participant's BMI will be measured during the clinic appointment when participant is recruited. AYA participants will then be asked to return for a study visit 3 months post intervention where their BMI will be measured again. Change in BMI will be measured with a decrease in BMI being associated with a positive outcome and an increase in BMI being associated with a negative outcome.
Systolic Blood Pressure (BP) From Baseline Baseline, 3 month post-enrollment AYA participants' systolic BP (SBP) will be measured during the clinic appointment when the participant is recruited. AYA participants will then be asked to return for a study visit 3 months post-intervention where their BP will be measured again. Change in SBP will be measured with a decrease in SBP being associated with a positive outcome and an increase in SBP being associated with a negative outcome.
Diastolic Blood Pressure (BP) From Baseline Baseline, 3 month post-enrollment AYA participants' diastolic BP (DBP) will be measured during the clinic appointment when the participant is recruited. AYA participants will then be asked to return for a study visit 3 months post-intervention where their BP will be measured again. Change in DBP will be measured with a decrease in diastolic BP being associated with a positive outcome and an increase in BP being associated with a negative outcome.
Trial Locations
- Locations (2)
Children's Healthcare of Atlanta - Hughes Spalding Research Room
🇺🇸Atlanta, Georgia, United States
Grady Health System
🇺🇸Atlanta, Georgia, United States