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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HL155253-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| #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. |
| 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.](streamdown:incomplete-link) | 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 |
| 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. |
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Inclusion Criteria (AYAs):
Exclusion Criteria (AYAs):
Inclusion Criteria (HCPs) to complete feasibility surveys:
Exclusion Criteria (HCPs)
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| Name | Affiliation | Role |
|---|---|---|
| Holly Gooding, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta - Hughes Spalding Research Room | Atlanta | Georgia | 30303 | United States | ||
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who provided consent to participate in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | 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. | Posted | Median | Inter-Quartile Range | Percentage Risk | Baseline, 3 months post-enrollment |
Data collection from study enrollment until study participation was completed, up to 3 months post-enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AYA Participants | AYA participants will complete a brief initial survey consisting of demographic information, the Visual Analog Scale (VAS), and the #HerHeart tool in the clinic. AYA participants will 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.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly Gooding | Emory University | 404-778-1429 | holly.gooding@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2022 | Aug 18, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2022 | Aug 18, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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 |
| 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 |
| Grady Health System |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
|
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| 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.](streamdown:incomplete-link) | 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. | Posted | Median | Inter-Quartile Range | Diet Score | Baseline, 3 months months post-enrollment |
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| Primary | Fruit and Vegetable Intake | Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome. | 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. | Posted | Median | Inter-Quartile Range | Number of Servings per day | Baseline, 3 months post- post-enrollment |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | number of servings per week | Baseline, 3 months post-enrollment |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | number of servings per week. | Baseline, 3 months post-enrollment |
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| Primary | Nut Consumption | Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome. | 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. | Posted | Median | Inter-Quartile Range | Number of Servings per week | Baseline, 3 months post-intervention |
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| Primary | Alcohol Consumption | Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome. | 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. | Posted | Count of Participants | Participants | Baseline, 3 months post-enrollment |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 3 months post-enrollment |
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| Primary | Cereal Fiber | Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome. | 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. | Posted | Median | Inter-Quartile Range | g/day | Baseline, 3 months post-enrollment |
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| Primary | Physical Activity | Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome. | 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. | Posted | Median | Inter-Quartile Range | number of hours per week | Baseline, 3 months post-enrollment |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | kg/m^2 | Baseline, 3 month post-enrollment |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | mmHg | Baseline, 3 month post-enrollment |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | mmHg | Baseline, 3 month post-enrollment |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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| Vegetables at Baseline |
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| Vegetables at 3 months post-enrollment |
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| Processed Meats at Baseline |
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| Processed Meats at 3 months post-enrollment |
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| Current Smoker |
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| Three months post-enrollment |
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| Moderate Physical Activity at Baseline |
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| Moderate Physical Activity at 3 months post-enrollment |
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