Cardiovascular Diseases
Conditions
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.
Interventions
BEHAVIORAL#HerHeart tool
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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%. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from Children's Healthcare of Atlanta - Hughes Spalding Research Room in Atlanta, Georgia, USA. Participant enrollment began July 01, 2022, and all follow-up assessments were completed by April 03, 2023.
Pre-assignment details
The healthcare providers (HCPs) were instructed to complete a short anonymous survey without demographic information. Demographic information was not required to answer the survey. HCPs were not enrolled. They were not actually part of the clinical trial, per the NIH definition of a clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| AYA Participants 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.
#HerHeart tool: 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 43 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | AYA Participants |
|---|---|
| Age, Categorical <=18 years | 44 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 17 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Alcohol Consumption
Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AYA Participants | Alcohol Consumption | Baseline | 0 Participants |
| AYA Participants | Alcohol Consumption | 3 months post-enrollment | 0 Participants |
Primary
Cereal Fiber
Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Cereal Fiber | Baseline | 0.30 g/day |
| AYA Participants | Cereal Fiber | Three months post-enrollment | 0.30 g/day |
Primary
Fruit and Vegetable Intake
Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.
Time frame: Baseline, 3 months post- post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Fruit and Vegetable Intake | Fruits at Baseline | 2.00 Number of Servings per day |
| AYA Participants | Fruit and Vegetable Intake | Fruits at 3 months post-enrollment | 1.5 Number of Servings per day |
| AYA Participants | Fruit and Vegetable Intake | Vegetables at Baseline | 1.00 Number of Servings per day |
| AYA Participants | Fruit and Vegetable Intake | Vegetables at 3 months post-enrollment | 2.00 Number of Servings per day |
Primary
#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%.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three months follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals. HCPs, n=5 from the same two clinical practices in Atlanta, Georgia were recruited by the research coordinator only to understand their perspectives about incorporating the HerHeart tool into clinical practice.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | #HerHEART Risk Score in AYA From Baseline | Baseline | 0.10 Percentage Risk |
| AYA Participants | #HerHEART Risk Score in AYA From Baseline | Three (3) months post-enrollment | 0.08 Percentage Risk |
Primary
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.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AYA Participants | Nicotine Use | Baseline | Never Smoke | 46 Participants |
| AYA Participants | Nicotine Use | Baseline | Used to Smoke | 4 Participants |
| AYA Participants | Nicotine Use | Baseline | Current Smoker | 10 Participants |
| AYA Participants | Nicotine Use | Three months post-enrollment | Never Smoke | 9 Participants |
| AYA Participants | Nicotine Use | Three months post-enrollment | Used to Smoke | 1 Participants |
| AYA Participants | Nicotine Use | Three months post-enrollment | Current Smoker | 0 Participants |
Primary
Nut Consumption
Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.
Time frame: Baseline, 3 months post-intervention
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Nut Consumption | Baseline | 0.30 Number of Servings per week |
| AYA Participants | Nut Consumption | 3 months post-intervention | 0.30 Number of Servings per week |
Primary
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.
Time frame: Baseline, 3 months months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Overall Composite of Diet Score | Three (3) months post-enrollment | 0.28 Diet Score |
| AYA Participants | Overall Composite of Diet Score | Baseline | 0.27 Diet Score |
Primary
Physical Activity
Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Physical Activity | Intense Physical Activity at Baseline | 0.75 number of hours per week |
| AYA Participants | Physical Activity | Intense Physical Activity at 3 months post-enrollment | 0.75 number of hours per week |
| AYA Participants | Physical Activity | Moderate Physical Activity at Baseline | 0.75 number of hours per week |
| AYA Participants | Physical Activity | Moderate Physical Activity at 3 months post-enrollment | 1.38 number of hours per week |
Primary
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.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Red and Processed Meats Intake | Red meats at baseline | 0.30 number of servings per week |
| AYA Participants | Red and Processed Meats Intake | Red meats at 3 months post-enrollment | 0.30 number of servings per week |
| AYA Participants | Red and Processed Meats Intake | Processed Meats at Baseline | 0.50 number of servings per week |
| AYA Participants | Red and Processed Meats Intake | Processed Meats at 3 months post-enrollment | 0.30 number of servings per week |
Primary
Sugar and Sweetened Beverages
Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.
Time frame: Baseline, 3 months post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three-month follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Sugar and Sweetened Beverages | Baseline | 0.30 number of servings per week. |
| AYA Participants | Sugar and Sweetened Beverages | Three months post-enrollment | 0.30 number of servings per week. |
Secondary
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.
Time frame: Baseline, 3 month post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three months follow-up includes only those who completed the study activities at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | BMI From Baseline | BMI at Baseline | 24 kg/m^2 |
| AYA Participants | BMI From Baseline | BMI at 3 months post-enrollment | 25 kg/m^2 |
Secondary
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.
Time frame: Baseline, 3 month post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three months follow-up includes only those who completed the study activities at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Diastolic Blood Pressure (BP) From Baseline | Baseline DBP | 67 mmHg |
| AYA Participants | Diastolic Blood Pressure (BP) From Baseline | DBP at 3 months post-enrollment | 67 mmHg |
Secondary
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.
Time frame: Baseline, 3 month post-enrollment
Population: Includes all participants who completed the baseline questionnaires, and the three months follow-up includes only those who completed the study activities at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AYA Participants | Systolic Blood Pressure (BP) From Baseline | SPB at Baseline | 118 mmHg |
| AYA Participants | Systolic Blood Pressure (BP) From Baseline | SBP at 3 months post-enrollment | 117 mmHg |