Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT03137433
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weight Loss With Meal-Replacement Therapy in Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly105@umn.edu', 'phone': '612-626-3492', 'title': 'Aaron Kelly, PhD', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 9, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 6, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Self report of taking laxatives', 'notes': 'Taken from the Eating Disorder Examination-Questionnaire (EDEQ) question 17', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Self induced vomiting', 'notes': 'Self report of making oneself sick based on the Eating Disorder Examination-Questionnaire, question 16.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Exacerbation of Asthma', 'notes': 'Hospitalization for asthma. Asthma was noted as a pre-existing condition at enrollment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acquired pneumonia and E-cigarette associated lung injury (EVALI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Body Mass Index (From Baseline to 1-year)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)', 'unitOfMeasure': 'Percent change in BMI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Fat Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Change in fat mass from randomization to week 52', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Carotid-radial Pulse Wave Velocity (m/s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Change in measure of arterial stiffness (from baseline to 1-year)', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Impact of Weight-related on Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Impact of Weight-related on Quality of Life Total Transformed Score (from physical comfort transformed score, body self esteem transformed score, social life transformed score, and family relations transformed score). Scores range from 0 to 100 with 100 representing the best quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Change in systolic blood pressure (from baseline to 1-year)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Change in diastolic blood pressure (from baseline to 1-year)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '153.9', 'spread': '30', 'groupId': 'OG000'}, {'value': '158.6', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Total cholesterol (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '9', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'High Density Lipoprotein (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.1', 'spread': '29', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Low Density Lipoprotein (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglyceride/HDL Cholesterol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Triglyceride/HDL cholesterol ratio (from baseline to 1-year)', 'unitOfMeasure': 'TG/HDL cholesterol ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'spread': '9', 'groupId': 'OG000'}, {'value': '87.4', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Total Glucose (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'OG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '16', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Insulin (mU/dL)', 'unitOfMeasure': 'mU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'FG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Moved out of study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Too far out of window due to COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'BG001', 'title': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group was provided additional information to go along with meal-replacements which was that they would be paid for their weight loss.\n\nMeal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age at study entry', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Number of participants randomized to each arm at the Baseline visit.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-06', 'size': 521826, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-12T09:37', 'hasProtocol': True}, {'date': '2021-06-07', 'size': 894570, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-12T09:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2017-04-25', 'resultsFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-13', 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index (From Baseline to 1-year)', 'timeFrame': '52 weeks', 'description': 'Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)'}], 'secondaryOutcomes': [{'measure': 'Total Fat Mass (kg)', 'timeFrame': '52 Weeks', 'description': 'Change in fat mass from randomization to week 52'}, {'measure': 'Carotid-radial Pulse Wave Velocity (m/s)', 'timeFrame': '52 weeks', 'description': 'Change in measure of arterial stiffness (from baseline to 1-year)'}, {'measure': 'Impact of Weight-related on Quality of Life', 'timeFrame': '52 weeks', 'description': 'Impact of Weight-related on Quality of Life Total Transformed Score (from physical comfort transformed score, body self esteem transformed score, social life transformed score, and family relations transformed score). Scores range from 0 to 100 with 100 representing the best quality of life.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '52 weeks', 'description': 'Change in systolic blood pressure (from baseline to 1-year)'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '52 weeks', 'description': 'Change in diastolic blood pressure (from baseline to 1-year)'}, {'measure': 'Total Cholesterol', 'timeFrame': '52 Weeks', 'description': 'Total cholesterol (mg/dL)'}, {'measure': 'HDL', 'timeFrame': '52 Weeks', 'description': 'High Density Lipoprotein (mg/dL)'}, {'measure': 'LDL', 'timeFrame': '52 Weeks', 'description': 'Low Density Lipoprotein (mg/dL)'}, {'measure': 'Triglyceride/HDL Cholesterol Ratio', 'timeFrame': '52 weeks', 'description': 'Triglyceride/HDL cholesterol ratio (from baseline to 1-year)'}, {'measure': 'Total Glucose', 'timeFrame': '52 Weeks', 'description': 'Total Glucose (mg/dL)'}, {'measure': 'Insulin', 'timeFrame': '52 Weeks', 'description': 'Insulin (mU/dL)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight loss', 'Cardiometabolic', 'Meal-replacement therapy'], 'conditions': ['Obesity, Severe', 'Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '38884967', 'type': 'DERIVED', 'citation': 'Gross AC, Freese RL, Bensignor MO, Bomberg EM, Dengel DR, Fox CK, Rudser KD, Ryder JR, Bramante CT, Raatz S, Lim F, Hur C, Kelly AS. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 1;178(8):753-762. doi: 10.1001/jamapediatrics.2024.1701.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to examine whether meal-replacement therapy is able to enhance weight loss among teens with severe obesity. In addition, we are also interested in examining the degree of weight loss needed to improve important cardiometabolic risk factors among adolescents.', 'detailedDescription': 'This study will involve 130 adolescents (ages 13-17 years old) participating in meal replacement therapy and will last one year (12 months).\n\nParticipants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.\n\nWe will measure the changes in resting metabolic rate, traditional clinical risk markers (TG, HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2\n* 13-17 years old\n\nExclusion Criteria:\n\n* Type 1 or 2 diabetes mellitus\n* Previous (within 6 months) or current use of meal replacements\n* Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)\n* If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months\n* Previous bariatric surgery\n* If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months\n* If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months\n* History of treatment with growth hormone\n* Neurodevelopmental disorder severe enough to impair ability to comply with study protocol\n* Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse\n* Females: currently pregnant or planning to become pregnant\n* Tobacco use\n* Bulimia nervosa\n* Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)\n* Binge eating disorder\n* Neurological disorder\n* Hypothalamic obesity\n* Obesity associated with genetic disorder (monogenetic obesity)\n* Hyperthyroidism or uncontrolled hypothyroidism\n* History of cholelithiasis'}, 'identificationModule': {'nctId': 'NCT03137433', 'briefTitle': 'Weight Loss With Meal-Replacement Therapy in Teens', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity', 'orgStudyIdInfo': {'id': 'PEDS-2017-25609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal-Replacements', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).', 'interventionNames': ['Dietary Supplement: Meal-replacement Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Meal-Replacements Plus', 'description': 'Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements.', 'interventionNames': ['Dietary Supplement: Meal-replacement Therapy']}], 'interventions': [{'name': 'Meal-replacement Therapy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.', 'armGroupLabels': ['Meal-Replacements', 'Meal-Replacements Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Aaron Kelly, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}