N/A
N=60
Incorporating CV Risk Assessment in AYA Visits
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05384834 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: #HerHEART Risk Score in AYA From Baseline — 0.10; 0.08 Percentage Risk
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- #HerHeart tool (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY #HerHEART Risk Score in AYA From Baseline |
0.10; 0.08 | — |
| PRIMARY Overall Composite of Diet Score |
0.27; 0.28 | — |
| PRIMARY Fruit and Vegetable Intake |
2.00; 1.5; 1.00; 2.00 | — |
| PRIMARY Red and Processed Meats Intake |
0.30; 0.30; 0.50; 0.30 | — |
| PRIMARY Sugar and Sweetened Beverages |
0.30; 0.30 | — |
| PRIMARY Nut Consumption |
0.30; 0.30 | — |
| PRIMARY Alcohol Consumption |
0; 0 | — |
| PRIMARY Nicotine Use |
46; 4; 10; 9; 1; 0 | — |
| PRIMARY Cereal Fiber |
0.30; 0.30 | — |
| PRIMARY Physical Activity |
0.75; 0.75; 0.75; 1.38 | — |
| SECONDARY BMI From Baseline |
24; 25 | — |
| SECONDARY Systolic Blood Pressure (BP) From Baseline |
118; 117 | — |
| SECONDARY Diastolic Blood Pressure (BP) From Baseline |
67; 67 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05384834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.