Incorporating CV Risk Assessment in AYA Visits

NCT05384834 | Completed Results

• 2 other identifiers: STUDY000014181R03HL155253-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (10)

• #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 Outcomes (3)

• 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

Study Arms (1)

AYA participants

EXPERIMENTAL

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

Interventions

#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.

AYA participants

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• Member of the research study team

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Children's Healthcare of Atlanta - Hughes Spalding Research Room

Atlanta, Georgia, 30303, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Holly Gooding
• Organization: Emory University

holly.gooding@emory.edu

404-778-1429

Study Officials

• Holly Gooding, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 20, 2022
• Study Start: July 1, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: October 13, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)