Skip to main content
OpenTrials
Completed

NCT Number: NCT05384834

Incorporating CV Risk Assessment in AYA Visits

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta - Hughes Spalding Research Room, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

#HerHeart tool

Behavioral

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.

Primary outcomes

  1. #HerHEART Risk Score in AYA From Baseline

    Time frame: 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%.

  2. Overall Composite of Diet Score

    Time frame: 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.

  3. Fruit and Vegetable Intake

    Time frame: 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.

  4. Red and Processed Meats Intake

    Time frame: 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.

  5. Sugar and Sweetened Beverages

    Time frame: 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.

  6. Nut Consumption

    Time frame: 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.

  7. Alcohol Consumption

    Time frame: Baseline, 3 months post-enrollment

    Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.

  8. Nicotine Use

    Time frame: 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.

  9. Cereal Fiber

    Time frame: 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.

  10. Physical Activity

    Time frame: 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.

Secondary outcomes

  1. BMI From Baseline

    Time frame: 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.

  2. Systolic Blood Pressure (BP) From Baseline

    Time frame: 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.

  3. Diastolic Blood Pressure (BP) From Baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2022
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.