Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03562767
Status:
TERMINATED
Last Update Posted:
2023-08-02
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akulshr@emory.edu', 'phone': '(404) 686-2410', 'title': 'Dr. Ambar Kulshreshtha', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated. A control group was intended to be added for the study, but the study team decided not to complete this additional research due to the COVID pandemic. Additional funds were not available to enroll the control group.'}}, 'adverseEventsModule': {'timeFrame': 'Three months post-randomization', 'description': 'Adverse events such as episodes of hypoglycemia, diabetes-related hospitalizations, and ER or urgent care visits will be ascertained during the study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants That Complete the Study Compared to Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post randomization', 'description': 'Feasibility of the intervention will be measured as the percentage of participants who complete the study. The intervention will be considered feasible if no more than 20% of participants are lost to follow up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post randomization', 'description': 'Acceptability of the intervention will be operationalized as study session attendance and will be considered adequate if at least 70% of the sessions are attended.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin A1c (HbA1C) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CBintervention Group-based CognitiveBehavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web-based CT-CBintervention Web-based CognitiveBehavioralIntervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1hour period for a web call from the behavioral interventionist team. Text reminders will be sent to the participants prior to the sessions. During this period, approximately 15minutes will be reserved for diabetes exercise and food planning education and approximately 45minutes of CT-CBengagement activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.35', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '9.21', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Hemoglobin A1c (HbA1C) in % will be measured via blood draw and processing. Normal values HbA1C are less than 5.7%, values between 5.7% and 6.4% indicate pre-diabetes, and persons with levels of 6.5% or higher are considered to have diabetes.', 'unitOfMeasure': 'percentage of HbA1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The A1C results may be affected by variations in point of care vs regular blood testing and the timing of follow up for participants. Data is included for participants who completed more than 65% of the intervention sessions.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire (PHQ-9) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.29', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '4.90', 'groupId': 'OG001'}]}]}, {'title': '3 months post randomization', 'categories': [{'measurements': [{'value': '7.71', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Depressive symptoms are assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Distress Scale (DDS17) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': '3 months post randomization', 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in 12-Item Short Form Health Survey (SF-12) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based or Web-based Cognitive Behavioral Intervention', 'description': 'Participants from both study arms are combined for this analysis.'}], 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12). The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was an error in data collection forms provided to participants, which made these questionnaires unusable for data analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.14', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': '3 months post randomization', 'categories': [{'measurements': [{'value': '6.00', 'spread': '5.80', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '4.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Anxiety will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) Scale. Participants use a 4-point scale in response to statements about anxiety (such as "trouble relaxing") to indicate how bothered they have felt by item over the last two weeks. Degree of anxiety is rated as 0 = "not at all" to 3 = "nearly every day". Total scores range from 0 to 21. Scores of 5-9 indicate mild anxiety, 10-15 indicates moderate anxiety and scores 15 and greater indicate severe anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in Self Efficacy for Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web-based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior to the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.34', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': '3 months post randomization', 'categories': [{'measurements': [{'value': '7.43', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Change in Self Efficacy is assessed by Self Efficacy for Diabetes Scale that is administered at Baseline and at 3rd month post randomization. The questionnaire is a 8 item scale. Each question ranks from 1(not confident at all) to 10 (totally confident). The scale score will be compared from Baseline to 3 months post randomization.\n\nFor diabetes, higher diabetes self-efficacy has been shown to relate to better self-care and glycaemic control. Increase in the score of Self-efficacy is found to directly reinforce adherence to self-care.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Health Belief Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'OG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Change in Diabetes Health Belief Scale is assessed by 25-item scale that is administered at baseline and at 3 months post randomization.Each question ranks from (1 = Strongly Disagree) to (5 = Strongly Agree).The scale score will be compared from Baseline to 3 months post randomization', 'reportingStatus': 'POSTED', 'populationDescription': 'This survey was not administered to participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'FG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'FG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Logistic Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention\n\nGroup-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.'}, {'id': 'BG001', 'title': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention\n\nWeb-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.'}, {'id': 'BG002', 'title': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers\n\nUsual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<55 Years Old', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': '≥55 Years Old', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'title': 'Normal (BMI 18.5-24.9 kg/m^2)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Overweight (BMI 25.0-29.9 kg/m^2)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Obese (BMI >= 30.0 kg/m^2)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A control group was intended to be added to the study, but the study team decided not to complete this additional research due to the pandemic. Additional funds were not available to enroll a new control group and thus, the study was terminated'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-01', 'size': 532567, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-15T10:50', 'hasProtocol': True}, {'date': '2020-12-15', 'size': 310301, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-30T17:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Research staff conducting the psychological, physical, outcome assessments, and study analyses will be blinded to participant's group allocation. To minimize bias, participants in the intervention group will be asked to refrain from disclosing their group assignment to study staff who collect data and questionnaires. Due to the overt nature of the CT-CB approach, the investigators and participants in the intervention group will not be blinded."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups of subjects with uncontrolled diabetes Type 2 will be followed longitudinally for 3 months'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'A control group was intended to be added to the study, but the study team decided not complete this additional research with the pandemic. Additional funds were also not available to enroll a new control group and thus, the study was terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2018-06-08', 'resultsFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-01', 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants That Complete the Study Compared to Enrolled', 'timeFrame': '3 months post randomization', 'description': 'Feasibility of the intervention will be measured as the percentage of participants who complete the study. The intervention will be considered feasible if no more than 20% of participants are lost to follow up.'}, {'measure': 'Percentage of Participants That Are Enrolled and Attend the Study the Study Sessions Compared to Enrolled', 'timeFrame': '3 months post randomization', 'description': 'Acceptability of the intervention will be operationalized as study session attendance and will be considered adequate if at least 70% of the sessions are attended.'}], 'secondaryOutcomes': [{'measure': 'Change in Hemoglobin A1c (HbA1C) Level', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Hemoglobin A1c (HbA1C) in % will be measured via blood draw and processing. Normal values HbA1C are less than 5.7%, values between 5.7% and 6.4% indicate pre-diabetes, and persons with levels of 6.5% or higher are considered to have diabetes.'}, {'measure': 'Change in Patient Health Questionnaire (PHQ-9) Score', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Depressive symptoms are assessed by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item scale where respondents indicate how much they are bothered by certain problems on a 4-point scale where 0 = not at all and 3 = nearly every day. Total scores range from 0 to 27 with degree of depression considered minimal for scores between 0-4, mild for scores of 5-9, moderate for scores of 10-14, moderate to severe for scores 15-19, and severe for scores of 20-27.'}, {'measure': 'Change in Diabetes Distress Scale (DDS17) Score', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'The Diabetes Distress Scale (DDS17) is a 17-item questionnaire assessing the severity of problems of living with diabetes. Participants indicate the degree to which each item impacts their life on a 6-point scale where 1 = not a problem and 6 = a very serious problem. The scores are summed and divided by 17 to generate an average score that can range from 1 to 6. Scores of 3 or more are considered high distress.'}, {'measure': 'Change in 12-Item Short Form Health Survey (SF-12) Score', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12). The Short Form-12 Health Survey Questionnaire (SF-12) is a measure of general physical and mental health. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.'}, {'measure': 'Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Anxiety will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) Scale. Participants use a 4-point scale in response to statements about anxiety (such as "trouble relaxing") to indicate how bothered they have felt by item over the last two weeks. Degree of anxiety is rated as 0 = "not at all" to 3 = "nearly every day". Total scores range from 0 to 21. Scores of 5-9 indicate mild anxiety, 10-15 indicates moderate anxiety and scores 15 and greater indicate severe anxiety.'}, {'measure': 'Change in Self Efficacy for Diabetes', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Change in Self Efficacy is assessed by Self Efficacy for Diabetes Scale that is administered at Baseline and at 3rd month post randomization. The questionnaire is a 8 item scale. Each question ranks from 1(not confident at all) to 10 (totally confident). The scale score will be compared from Baseline to 3 months post randomization.\n\nFor diabetes, higher diabetes self-efficacy has been shown to relate to better self-care and glycaemic control. Increase in the score of Self-efficacy is found to directly reinforce adherence to self-care.'}, {'measure': 'Change in Diabetes Health Belief Scale', 'timeFrame': 'Baseline and 3 months post randomization', 'description': 'Change in Diabetes Health Belief Scale is assessed by 25-item scale that is administered at baseline and at 3 months post randomization.Each question ranks from (1 = Strongly Disagree) to (5 = Strongly Agree).The scale score will be compared from Baseline to 3 months post randomization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Culturally-Tailored Cognitive Behavior intervention (CT-CB)', 'Family Practice', 'Diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35597972', 'type': 'DERIVED', 'citation': 'Cornely RM, Subramanya V, Owen A, McGee RE, Kulshreshtha A. A mixed-methods approach to understanding the perspectives, experiences, and attitudes of a culturally tailored cognitive behavioral therapy/motivational interviewing intervention for African American patients with type 2 diabetes: a randomized parallel design pilot study. Pilot Feasibility Stud. 2022 May 21;8(1):107. doi: 10.1186/s40814-022-01066-4.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to assess the feasibility and acceptability of a Culturally-Tailored Cognitive Behavior intervention (CT-CB) for African American patients with uncontrolled Type 2 diabetes. After the baseline visit subjects will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). The intervention duration is 12 weeks.', 'detailedDescription': 'African Americans are approximately twice as likely to be diagnosed with diabetes and to experience gaps in diabetes care compared to Whites. Lower health literacy and socio-economic, language, and communication barriers are all associated with disparities in diabetes care. The role of Behavioral theory is foundational in understanding behavior change among patients in the self-management of diabetes. Further culturally tailoring increases acceptance and effectiveness of diabetes self-management.\n\nThe aim of this pilot study is to test the feasibility and acceptability of a culturally tailored, cognitive behavioral intervention (CT-CB) program using a group-based vs. a web-based format, and determine if it can improve diabetes self-management among African Americans compared with usual individual based care at the clinic. Forty-five African American patients with uncontrolled type 2 diabetes (HbA1C \\> 8 %), aged \\> 18 years, will be randomly assigned to undergo a six session group-based or web-based behavioral intervention (CT-CB) program or to general education (usual care). After 12 weeks, patients will be followed for an additional three months to evaluate for diminution of treatment effects. Both the group -based and the web-based CBT intervention group will be followed for an additional three months to study for possible diminution of treatment effects over time.\n\nDiabetic measures like Hemoglobin (HbA1C) at baseline vs. 3 months; the Patient Health Questionnaire to assess depressive symptoms; Diabetes Distress Scale, anxiety, self-efficacy, quality of life (SF-12), Diabetes Health Belief Scale, process measures such as Patient Activation Measure (PAM-13), medication adherence questionnaire, session-participation, glucose self-monitoring, diet and physical activity are measured at each visit pre and post intervention. Trained study staff will also conduct neuropsychological tests including language and memory tests, attention and executive function tests, clinical diagnosis, activities of daily living (ADL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years or older\n* Fluency in English\n* African American\n* HbA1C\\>8%\n\nExclusion Criteria:\n\n* Subjects with no web access,\n* Subjects using an insulin pump,\n* Subjects that are pregnant\n* Subjects that have active substance abuse including alcohol,\n* Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions'}, 'identificationModule': {'nctId': 'NCT03562767', 'briefTitle': 'Cognitive Behavioral Therapy for African Americans With Uncontrolled Type-2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Randomized Single Blinded Interventional Study to Assess the Feasibility and Acceptability of a Culturally-Tailored Cognitive Behavior Intervention (CT-CB) for African American Patients With Uncontrolled Type 2 Diabetes and to Compare the Effects of Intervention to Standard of Care on Diabetes Control Measures.', 'orgStudyIdInfo': {'id': 'IRB00101847'}, 'secondaryIdInfos': [{'id': 'P30DK111024', 'link': 'https://reporter.nih.gov/quickSearch/P30DK111024', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the group-based CT-CB intervention', 'interventionNames': ['Behavioral: Group-based Cognitive Behavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Web-based Cognitive Behavioral Intervention', 'description': 'Subjects receiving the web based CT-CB intervention', 'interventionNames': ['Behavioral: Web-based Cognitive Behavioral Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'description': 'Subjects receiving usual care from their primary care providers', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Group-based Cognitive Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.', 'armGroupLabels': ['Group-based Cognitive Behavioral Intervention']}, {'name': 'Web-based Cognitive Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.', 'armGroupLabels': ['Web-based Cognitive Behavioral Intervention']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Dunwoody Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Ambar Kulshreshtha, MD, PhD FAHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share the participants data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Family and Preventive Medicine', 'investigatorFullName': 'Ambar Kulshreshtha', 'investigatorAffiliation': 'Emory University'}}}}