Incorporating CV Risk Assessment in AYA Visits

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: #HerHeart tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (AYAs): Patient at CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program Age 13-21 years Self-identifying as non-Hispanic Black or White race (inclusive of Hispanic ethnicity) Self-identifying as female Visit type is annual wellness/health check, behavioral/mental health, or reproductive/gynecological health Consistent access to a mobile device with internet capability Exclusion Criteria (AYAs): Cognitive impairment limiting ability to complete study procedure Spoken and written language other than English Diagnosis of hypertension, diabetes, or hyperlipidemia requiring medications, or atherosclerotic cardiovascular disease Past or current diagnosis of a DSM-V eating disorder Diagnosis of schizophrenia, bipolar disorder, or psychiatric hospitalization in the past 12 months Pregnant at the time of the study. Inclusion Criteria (HCPs) to complete feasibility surveys: Clinical team member (physician or nurse practitioner, nurse, social worker, psychologist, health educator, medical assistant, dietitian) at the CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program Practicing at one of the study sites at least twice per month on average over the past year Exclusion Criteria (HCPs) Member of the research study team

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AYA participants<br>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. | Behavioral: #HerHeart tool<br>* An integrated application consisting of a lifestyle-based CVD risk assessment and companion behavioral intervention. It will be administered at baseline and 3 months follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| #HerHEART Risk Score in AYA From Baseline | 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%. | Baseline, 3 months post-enrollment | 
| Overall Composite of Diet Score | 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. | Baseline, 3 months months post-enrollment | 
| Fruit and Vegetable Intake | Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome. | Baseline, 3 months post- post-enrollment | 
| Red and Processed Meats Intake | Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome. | Baseline, 3 months post-enrollment | 
| Sugar and Sweetened Beverages | Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome. | Baseline, 3 months post-enrollment | 
| Nut Consumption | Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome. | Baseline, 3 months post-intervention | 
| Alcohol Consumption | Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome. | Baseline, 3 months post-enrollment | 
| Nicotine Use | 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. | Baseline, 3 months post-enrollment | 
| Cereal Fiber | Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome. | Baseline, 3 months post-enrollment | 
| Physical Activity | Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome. | Baseline, 3 months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI From Baseline | 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. | Baseline, 3 month post-enrollment | 
| Systolic Blood Pressure (BP) From Baseline | 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. | Baseline, 3 month post-enrollment | 
| Diastolic Blood Pressure (BP) From Baseline | 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. | Baseline, 3 month post-enrollment |