Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-13 @ 9:19 AM
Study NCT ID:
NCT04924400
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'tmorland@geisinger.edu', 'phone': '703-593-0088', 'title': 'Dr. Thomas Morland', 'organization': 'Geisinger'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This was a pilot and feasibility study, not powered to answer questions regarding the effect of the intervention.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not tracked for this minimal risk study.', 'description': 'There was not formal monitoring for Serious Adverse Events. The study team is not aware of any deaths or serious adverse events among intervention or control participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '-0.01'}, {'value': '-0.58', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '-0.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in HbA1c after 6 months compared to baseline', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-eight individuals consented to participated in this study. Nineteen were randomized to both the control and intervention groups. Seven intervention and eight control participants provided 6-month biomarkers/biometrics.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Completed Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'title': 'Consented to participate but did not attend baseline biomarkers', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Provided baseline biomarkers but no further biomarkers', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Provided baseline and 3 month biomarkers only', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Provided all biomarkers (baseline, 3-month, 6-month)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'What percentage of individuals completed biomarkers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Who Completed Biometrics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'title': 'Consented to participate but did not provide baseline biometrics', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Provided baseline biometrics but no further biometrics', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Provided baseline and 3 month biometrics only', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Provided all biometrics (baseline, 3-month, 6-month)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 months', 'description': 'What percentage of individuals completed biometrics', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-eight individuals consented to participate in this study and 19 were randomized to both the control and intervention groups.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Contacted Who Agreed to Participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1644', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Participants', 'description': 'GHP members meeting criteria for enrollment based upon electronic query of database available for preparation to research process. Members were contacted by letter, electronic portal, and/or telephone call. Participation rates are based upon patients excluded based upon inclusion/exclusion criteria, those who chose not to participate due to transportation issues, those who chose not to participate for another reason, and those who did consent to participate.'}], 'classes': [{'title': 'Members called at least once', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1644', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1087', 'groupId': 'OG000'}]}]}, {'title': 'Unable to reach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '690', 'groupId': 'OG000'}]}]}, {'title': 'Did not meet inclusion/exclusion criteria after telephone screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Declined due to transportation issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Declined for another reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}]}]}, {'title': 'Consented to participate in the study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'What percentage of individuals contacted who agreed to participate in the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 1,644 members were identified for recruitment and a letter was mailed to this group introducing the study. Of those who received a recruitment mailing, 1,087 members received at least one phone call to assess interest in participating in this study.'}, {'type': 'SECONDARY', 'title': 'HbA1c Control at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.92', 'groupId': 'OG000', 'lowerLimit': '-1.81', 'upperLimit': '-0.03'}, {'value': '-0.58', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '-0.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in HbA1c percentage at 3 months compared to at baseline', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL-C at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.11', 'groupId': 'OG000', 'lowerLimit': '-15.48', 'upperLimit': '7.25'}, {'value': '-8.58', 'groupId': 'OG001', 'lowerLimit': '-25.80', 'upperLimit': '8.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in LDL-C levels at 3 compared to baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nineteen individuals were randomized to each group. Some participants did not return for the 3 and/or 6 month biomarker/biometric collection, resulting in fewer participants being included in the analysis at these timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Weight at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.15', 'groupId': 'OG000', 'lowerLimit': '-11.02', 'upperLimit': '0.72'}, {'value': '-2.22', 'groupId': 'OG001', 'lowerLimit': '-4.86', 'upperLimit': '0.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3months', 'description': 'Change in weight at 3 months compared to baseline', 'unitOfMeasure': 'Pounds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.38', 'groupId': 'OG000', 'lowerLimit': '-15.49', 'upperLimit': '0.74'}, {'value': '-2.10', 'groupId': 'OG001', 'lowerLimit': '-5.69', 'upperLimit': '1.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in weight at 6 months compared to baseline', 'unitOfMeasure': 'Pounds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Behaviors, as Measured by CHIP Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Overall program completion, defined as completing the majority of study activities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participation in at least half of designated study activities'}, {'type': 'SECONDARY', 'title': 'Number of Diabetes Medications Prescribed at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark).', 'unitOfMeasure': 'Medications', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LDL-C at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.71', 'groupId': 'OG000', 'lowerLimit': '-20.30', 'upperLimit': '10.87'}, {'value': '-8.58', 'groupId': 'OG001', 'lowerLimit': '-25.80', 'upperLimit': '8.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in LDL-C at 6 months compared to baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure After 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.50', 'groupId': 'OG000', 'lowerLimit': '-12.54', 'upperLimit': '3.54'}, {'value': '-16.00', 'groupId': 'OG001', 'lowerLimit': '-26.02', 'upperLimit': '-5.98'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in systolic blood pressure at 3 months compared to baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '4.13', 'groupId': 'OG000', 'lowerLimit': '-8.89', 'upperLimit': '17.14'}, {'value': '-4.83', 'groupId': 'OG001', 'lowerLimit': '-14.46', 'upperLimit': '4.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in systolic blood pressure at 6 months compared to baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '-4.93', 'upperLimit': '7.18'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-5.68', 'upperLimit': '3.68'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in diastolic blood pressure at 6 months compared to baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure After 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '-4.36', 'upperLimit': '5.16'}, {'value': '-4.83', 'groupId': 'OG001', 'lowerLimit': '-11.57', 'upperLimit': '1.90'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in diastolic blood pressure at 3 months compared to baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Cost of Care, Versus Same 6 Months Year Prior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'units': 'dollars', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '-859', 'spread': '12161', 'groupId': 'OG000'}, {'value': '1303', 'spread': '2870', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months of participation compared to same period one year prior', 'description': "This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment", 'unitOfMeasure': 'Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dollars', 'denomUnitsSelected': 'dollars', 'populationDescription': 'Please note discrepancy between number of patients analyzed and those enrolled/randomized. Individuals randomized to either the intervention or control who completed to study activities (i.e. did not attend any biomarker/biometric collections or CHIP classes) were excluded. Participants in the intervention and control group who gave baseline biomarkers and/or biometrics were included in the cost analyses'}, {'type': 'SECONDARY', 'title': 'Change in Total Cost of Care Versus 6 Months Leading to Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'OG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'classes': [{'categories': [{'measurements': [{'value': '1174', 'spread': '5001', 'groupId': 'OG000'}, {'value': '-97', 'spread': '1628', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months beginning with first day of intervention versus 6 months leading up to that day', 'description': 'This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note discrepancy between number of patients analyzed and those enrolled/randomized. Individuals randomized to either the intervention or control who completed to study activities (i.e. did not attend any biomarker/biometric collections or CHIP classes) were excluded. Participants in the intervention and control group who gave baseline biomarkers and/or biometrics were included in the cost analyses'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'FG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Please note discrepancy between overall number of patients enrolled and number listed participating. This is due to a flaw in the study design, in which patients underwent informed consent online from home, immediately after which randomization occurred. 38 participants provided informed consent and were randomized (19 participants to each arm), but 6 and 7 intervention and control participants, respectively) did not participate in any study activities following enrollment and randomization.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'Please note discrepancy between overall number of patients enrolled and number listed participating. This is due to a flaw in the study design, in which patients underwent informed consent online from home, immediately after which randomization occurred. 38 participants provided informed consent and were randomized (19 participants to each arm), but 6 and 7 intervention and control participants, respectively) did not participate in any study activities following enrollment and randomization.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were sent letters and/or electronic portal messages inviting them to participate. Research staff followed up with recruitment phone calls.', 'preAssignmentDetails': 'Participants were randomized to the intervention versus control arms after providing informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.\n\nCHIP Program: GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'BG001', 'title': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.\n\nUsual Care: GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'spread': '9.27', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '12.40', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '11.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '7 patients randomized to the control group did not attend baseline biomarkers/biometrics; 6 patients in the intervention group did not attend baseline biomarker/biometrics'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-04', 'size': 350459, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-12T16:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2021-05-20', 'resultsFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-12', 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '6 months', 'description': 'Change in HbA1c after 6 months compared to baseline'}, {'measure': 'Percentage of Patients Who Completed Biomarkers', 'timeFrame': '3 and 6 months', 'description': 'What percentage of individuals completed biomarkers'}, {'measure': 'Percentage of Patients Who Completed Biometrics', 'timeFrame': '3 and 6 months', 'description': 'What percentage of individuals completed biometrics'}, {'measure': 'Percentage of Patients Contacted Who Agreed to Participate', 'timeFrame': 'Baseline', 'description': 'What percentage of individuals contacted who agreed to participate in the study'}], 'secondaryOutcomes': [{'measure': 'HbA1c Control at 3 Months', 'timeFrame': '3 months', 'description': 'Change in HbA1c percentage at 3 months compared to at baseline'}, {'measure': 'LDL-C at 3 Months', 'timeFrame': '3 months', 'description': 'Change in LDL-C levels at 3 compared to baseline'}, {'measure': 'Change in Weight at 3 Months', 'timeFrame': '3months', 'description': 'Change in weight at 3 months compared to baseline'}, {'measure': 'Change in Weight at 6 Months', 'timeFrame': '6 months', 'description': 'Change in weight at 6 months compared to baseline'}, {'measure': 'Health Behaviors, as Measured by CHIP Participation', 'timeFrame': '6 months', 'description': 'Overall program completion, defined as completing the majority of study activities'}, {'measure': 'Number of Diabetes Medications Prescribed at 6 Months', 'timeFrame': '6 months', 'description': 'Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark).'}, {'measure': 'Change in LDL-C at 6 Months', 'timeFrame': '6 months', 'description': 'Change in LDL-C at 6 months compared to baseline'}, {'measure': 'Systolic Blood Pressure After 3 Months', 'timeFrame': '3 months', 'description': 'Change in systolic blood pressure at 3 months compared to baseline'}, {'measure': 'Systolic Blood Pressure at 6 Months', 'timeFrame': '6 months', 'description': 'Change in systolic blood pressure at 6 months compared to baseline'}, {'measure': 'Diastolic Blood Pressure at 6 Months', 'timeFrame': '6 months', 'description': 'Change in diastolic blood pressure at 6 months compared to baseline'}, {'measure': 'Diastolic Blood Pressure After 3 Months', 'timeFrame': '3 months', 'description': 'Change in diastolic blood pressure at 3 months compared to baseline'}, {'measure': 'Change in Total Cost of Care, Versus Same 6 Months Year Prior', 'timeFrame': '6 months of participation compared to same period one year prior', 'description': "This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment"}, {'measure': 'Change in Total Cost of Care Versus 6 Months Leading to Intervention', 'timeFrame': '6 months beginning with first day of intervention versus 6 months leading up to that day', 'description': 'This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The Complete Health Improvement Program (CHIP) is a lifestyle improvement program intended to prevent and/or manage cardiovascular disease, diabetes, and other health conditions. This is a pilot-scale randomized-controlled trial comparing the clinical, utilization, and financial outcomes of adult health plan members with type 2 diabetes mellitus (T2DM) offered CHIP versus those only offered standard health plan coverage. We hypothesize that Geisinger Health Plan (GHP) members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.', 'detailedDescription': 'This is a pilot prospective randomized-controlled trial of 60 patients randomized to either the intervention group; in which patients enroll in the CHIP program, or the control group, in which patients follow their usual diabetes care. We hypothesize that Geisinger Health Plan members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.\n\nThe intervention group will attend 18 classes covering topics such as diet, sleep, exercise instruction, stress management, and toxic substance avoidance. Biometrics (weight, BMI, waist circumference, systolic/diastolic blood pressure), biomarkers (HbA1c, LDL-C) and psychometrics (Wellbeing 360 survey) will be collected on all participants at baseline, 3-months and 6-months.\n\nThe CHIP curriculum will be administered during twice weekly 1-hour classes over a 6-week period, followed by weekly 1-hour classes for an additional 6 weeks. The protocol will begin with a 1-month in-person period, with participants subsequently offered the choice between in-person and online attendance for the remaining sessions.\n\nThe primary aim is to compare change in HbA1c, LDL-C, systolic blood pressure, body mass index, and waist circumference for GHP members offered CHIP versus members offered standard insurance coverage at 3- and 6-months.\n\nThrough this pilot study, we hope to gain insight into whether and how such an application of CHIP could be a cost-effective tool for health plans such as GHP to achieve clinical and financial goals for adult members with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Geisinger Health Plan member for a full year prior to enrollment in the study, with plans to remain covered for a full year after the first study visit\n* HbA1c resulted within a year of enrollment in the study\n* ≥ 18 years\n* Current type 2 diabetes diagnosis\n* Living in the five-county region served by the Miller Center (Lycoming, Montour, Northumberland, Snyder and Union) with the ability to arrange their own transportation to the Miller Center in Lewisburg at least 10 times in a 3-month period\n* Access to computer, phone, or tablet with sufficient internet to complete program activities.\n\nExclusion Criteria:\n\n* Presence of medical condition requiring specific diet (e.g., Celiac disease, phenylketonuria)\n* Presence of medical condition contraindicating participation in CHIP, as determined by the Principal Investigator (e.g. cancer on active treatment)\n* Pregnancy or plan to become pregnant within one year\n* Inability to give informed consent due to mental or psychiatric impairment\n* Participation in the Fresh Food Farmacy program'}, 'identificationModule': {'nctId': 'NCT04924400', 'acronym': 'CHIP-RCT', 'briefTitle': 'Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2020-0438'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHIP Program', 'description': 'GHP members randomized to the intervention arm will participate in the CHIP Program.', 'interventionNames': ['Behavioral: CHIP Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Diabetes Care', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'CHIP Program', 'type': 'BEHAVIORAL', 'description': 'GHP members randomized to the intervention arm will participate in the following activities:\n\n* Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.\n* Receive a copy of The Optimal Diet, The Official CHIP Cookbook.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey', 'armGroupLabels': ['CHIP Program']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.\n\nThe following data will be collected at weeks 1,12 and 26:\n\n* Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure\n* Biomarkers (blood tests): HbA1c, LDL-C\n* Psychometrics: Wellbeing360 survey', 'armGroupLabels': ['Usual Diabetes Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Thomas B Morland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Morland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Thomas Morland', 'investigatorAffiliation': 'Geisinger Clinic'}}}}