Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT05384834
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2022-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incorporating CV Risk Assessment in AYA Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'holly.gooding@emory.edu', 'phone': '404-778-1429', 'title': 'Dr. Holly Gooding', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data collection from study enrollment until study participation was completed, up to 3 months post-enrollment.', 'eventGroups': [{'id': 'EG000', 'title': 'AYA Participants', 'description': '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.\n\n* 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.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '#HerHEART Risk Score in AYA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.13'}]}]}, {'title': 'Three (3) months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': "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%.", 'unitOfMeasure': 'Percentage Risk', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Overall Composite of Diet Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '1.11'}]}]}, {'title': 'Three (3) months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '1.11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months months post-enrollment', 'description': '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.', 'unitOfMeasure': 'Diet Score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Fruit and Vegetable Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Fruits at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': 'Fruits at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': 'Vegetables at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '2.00'}]}]}, {'title': 'Vegetables at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post- post-enrollment', 'description': 'Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.', 'unitOfMeasure': 'Number of Servings per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Red and Processed Meats Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Red meats at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.50'}]}]}, {'title': 'Red meats at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.88'}]}]}, {'title': 'Processed Meats at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '1.00'}]}]}, {'title': 'Processed Meats at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome.', 'unitOfMeasure': 'number of servings per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Sugar and Sweetened Beverages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.50'}]}]}, {'title': 'Three months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.', 'unitOfMeasure': 'number of servings per week.', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Nut Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.30'}]}]}, {'title': '3 months post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-intervention', 'description': 'Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.', 'unitOfMeasure': 'Number of Servings per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Nicotine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never Smoke', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'Used to Smoke', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Three months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never Smoke', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Used to Smoke', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Cereal Fiber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.50'}]}]}, {'title': 'Three months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.', 'unitOfMeasure': 'g/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Intense Physical Activity at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.06'}]}]}, {'title': 'Intense Physical Activity at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '2.00'}]}]}, {'title': 'Moderate Physical Activity at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '2.00'}]}]}, {'title': 'Moderate Physical Activity at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.', 'unitOfMeasure': 'number of hours per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'BMI From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'BMI at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '28'}]}]}, {'title': 'BMI at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (BP) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'SPB at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '121'}]}]}, {'title': 'SBP at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '133'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure (BP) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'classes': [{'title': 'Baseline DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '71'}]}]}, {'title': 'DBP at 3 months post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AYA Participants', 'description': '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.\n\n#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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who provided consent to participate in the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-28', 'size': 346593, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-18T12:25', 'hasProtocol': True}, {'date': '2022-11-04', 'size': 249970, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-18T12:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2022-05-13', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-15', 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '#HerHEART Risk Score in AYA From Baseline', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': "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%."}, {'measure': 'Overall Composite of Diet Score', 'timeFrame': 'Baseline, 3 months months post-enrollment', 'description': '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.'}, {'measure': 'Fruit and Vegetable Intake', 'timeFrame': 'Baseline, 3 months post- post-enrollment', 'description': 'Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.'}, {'measure': 'Red and Processed Meats Intake', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome.'}, {'measure': 'Sugar and Sweetened Beverages', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.'}, {'measure': 'Nut Consumption', 'timeFrame': 'Baseline, 3 months post-intervention', 'description': 'Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.'}, {'measure': 'Alcohol Consumption', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.'}, {'measure': 'Nicotine Use', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': '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.'}, {'measure': 'Cereal Fiber', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline, 3 months post-enrollment', 'description': 'Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.'}], 'secondaryOutcomes': [{'measure': 'BMI From Baseline', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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."}, {'measure': 'Systolic Blood Pressure (BP) From Baseline', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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."}, {'measure': 'Diastolic Blood Pressure (BP) From Baseline', 'timeFrame': 'Baseline, 3 month post-enrollment', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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.\n\nThe 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (AYAs):\n\n* Patient at CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program\n* Age 13-21 years\n* Self-identifying as non-Hispanic Black or White race (inclusive of Hispanic ethnicity)\n* Self-identifying as female\n* Visit type is annual wellness/health check, behavioral/mental health, or reproductive/gynecological health\n* Consistent access to a mobile device with internet capability\n\nExclusion Criteria (AYAs):\n\n* Cognitive impairment limiting ability to complete study procedure\n* Spoken and written language other than English\n* Diagnosis of hypertension, diabetes, or hyperlipidemia requiring medications, or atherosclerotic cardiovascular disease\n* Past or current diagnosis of a DSM-V eating disorder\n* Diagnosis of schizophrenia, bipolar disorder, or psychiatric hospitalization in the past 12 months\n* Pregnant at the time of the study.\n\nInclusion Criteria (HCPs) to complete feasibility surveys:\n\n* 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\n* Practicing at one of the study sites at least twice per month on average over the past year\n\nExclusion Criteria (HCPs)\n\n* Member of the research study team'}, 'identificationModule': {'nctId': 'NCT05384834', 'briefTitle': 'Incorporating CV Risk Assessment in AYA Visits', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health', 'orgStudyIdInfo': {'id': 'STUDY00001418'}, 'secondaryIdInfos': [{'id': '1R03HL155253-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03HL155253-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AYA participants', 'description': '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.', 'interventionNames': ['Behavioral: #HerHeart tool']}], 'interventions': [{'name': '#HerHeart tool', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['AYA participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Hughes Spalding Research Room", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Health System', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Holly Gooding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Holly Gooding', 'investigatorAffiliation': 'Emory University'}}}}