Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-28 @ 11:43 PM
Study NCT ID:
NCT03329300
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marissa.gowey.phd@gmail.com', 'phone': '2056386618', 'title': 'Marissa Gowey, PhD', 'organization': 'University of Alabama at Birmingham Department of Pediatrics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Children', 'description': 'Family-based Behavioral Treatment (FBT)\n\nFamily-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parents/Caregivers', 'description': 'Family-based Behavioral Treatment (FBT)\n\nFamily-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Child Body Fat Mass at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.96', 'spread': '3.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Dual-energy X-ray Absorptiometry (DXA)', 'unitOfMeasure': '%bf tblh (total body less head)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'DXA scans were not performed on parents.caregivers.'}, {'type': 'SECONDARY', 'title': 'Adherence to Treatment (Number of Contact Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Family-based Behavioral Treatment (FBT)\n\nFamily-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.48', 'spread': '10.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'The number of contact hours participant was exposed to treatment', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessed on the dyad level'}, {'type': 'SECONDARY', 'title': 'Adherence to Treatment (Completed Days of Self-monitoring)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'timeFrame': 'Baseline to 6 months', 'description': 'The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected; USDA Supertracker software was discontinued and thus not able to be used to collect data as planned.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child Height', 'timeFrame': 'Baseline and 6 months', 'description': 'Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Child Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Child Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.05', 'spread': '.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean.\n\nChange in child BMI z-score was calculated by subtracting child BMI z-score at 6 months from child BMI z-score at baseline. Negative scores indicate that BMI z-score decreased across the 6 month treatment period (i.e., better outcome), whereas positive scores indicate that BMI z-score increased from 0 to 6 months (i.e., worse outcome).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Parent/caregiver BMI not reported as zscore'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parent/Guardian Height', 'timeFrame': 'Baseline and 6 months', 'description': 'Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parent/Guardian Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Parent/Guardian Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.48', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Parent/guardian height and weight will be used together to determine BMI (kg/m\\^2). Raw BMI score at 6 months was subtracted from raw BMI score at baseline to calculate the change in BMI score from 0 to 6 months (i.e., treatment duration). Negative scores indicate a decrease in BMI (i.e., better outcome) whereas positive scores indicated an increase in BMI (i.e., worse outcome) from baseline to 6 months.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Child BMI change not calculated using raw scores.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Executive Functioning - Inhibitory Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '5.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Executive Functioning - Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '.40', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '6.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Executive Functioning - Cognitive Flexibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'OG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '12.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children', 'description': 'Family-based Behavioral Treatment (FBT)\n\nFamily-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.'}, {'id': 'FG001', 'title': 'Parents/Caregivers', 'description': 'Family-based Behavioral Treatment (FBT)\n\nFamily-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Children', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'BG001', 'title': 'Parents/Caregivers', 'description': 'There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '26.21', 'spread': '17.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], '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': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Child Body Fat Mass (DXA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '5.34', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '5.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%bf tblh (total body less head)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'DXA scans were not performed on parents/caregivers'}, {'title': 'Child Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.41', 'spread': '0.36', 'groupId': 'BG000'}, {'value': '2.41', 'spread': '0.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only child BMI is reported as a zscore'}, {'title': 'Parent Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '37.2', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMI Percentile', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only parent/caregiver BMI is reported as percentile'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '149.24', 'spread': '7.27', 'groupId': 'BG000'}, {'value': '163.35', 'spread': '4.91', 'groupId': 'BG001'}, {'value': '156.30', 'spread': '9.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.67', 'spread': '20.11', 'groupId': 'BG000'}, {'value': '98.20', 'spread': '32.44', 'groupId': 'BG001'}, {'value': '86.44', 'spread': '29.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Executive Functioning', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.12', 'spread': '11.11', 'groupId': 'BG000'}, {'value': '52.71', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '52.41', 'spread': '10.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BRIEF Global Executive Composite, T-score:\n\nT-scores have a population mean of 50 and a standard deviation of 10.\n\nHigher scores indicate greater executive dysfunction. Corresponding T-scores and percentiles based on age and sex are assigned using raw scores. A score of 65 or above on any scale or index suggests potential clinical impairment (Gioia et al., 2000).', 'unitOfMeasure': 't-score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-15', 'size': 130905, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-25T13:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2017-10-25', 'resultsFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-25', 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child Height', 'timeFrame': 'Baseline and 6 months', 'description': 'Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.'}, {'measure': 'Child Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.'}, {'measure': 'Change in Child Body Mass Index', 'timeFrame': 'Baseline to 6 months', 'description': 'Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean.\n\nChange in child BMI z-score was calculated by subtracting child BMI z-score at 6 months from child BMI z-score at baseline. Negative scores indicate that BMI z-score decreased across the 6 month treatment period (i.e., better outcome), whereas positive scores indicate that BMI z-score increased from 0 to 6 months (i.e., worse outcome).'}, {'measure': 'Parent/Guardian Height', 'timeFrame': 'Baseline and 6 months', 'description': 'Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.'}, {'measure': 'Parent/Guardian Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.'}, {'measure': 'Change in Parent/Guardian Body Mass Index', 'timeFrame': 'Baseline to 6 months', 'description': 'Parent/guardian height and weight will be used together to determine BMI (kg/m\\^2). Raw BMI score at 6 months was subtracted from raw BMI score at baseline to calculate the change in BMI score from 0 to 6 months (i.e., treatment duration). Negative scores indicate a decrease in BMI (i.e., better outcome) whereas positive scores indicated an increase in BMI (i.e., worse outcome) from baseline to 6 months.'}, {'measure': 'Change in Executive Functioning - Inhibitory Control', 'timeFrame': 'Baseline and 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.'}, {'measure': 'Change in Executive Functioning - Working Memory', 'timeFrame': 'Baseline and 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.'}, {'measure': 'Change in Executive Functioning - Cognitive Flexibility', 'timeFrame': 'Baseline to 6 months', 'description': 'Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline Child Body Fat Mass at 6 Months', 'timeFrame': 'Baseline to 6 months', 'description': 'Dual-energy X-ray Absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Adherence to Treatment (Number of Contact Hours)', 'timeFrame': 'Baseline to 6 months', 'description': 'The number of contact hours participant was exposed to treatment'}, {'measure': 'Adherence to Treatment (Completed Days of Self-monitoring)', 'timeFrame': 'Baseline to 6 months', 'description': 'The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Obesity', 'Executive Function', 'Behavioral Intervention'], 'conditions': ['Pediatric Obesity', 'Executive Function']}, 'descriptionModule': {'briefSummary': 'We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.', 'detailedDescription': 'Baseline assessments will include child and parent demographic data, medical history, and cognitive functioning, along with anthropometric measures such as height, weight, and body composition. Those who complete baseline assessments will be enrolled in one of two groups of family-based treatment on after-school evenings (8 pairs in each group; total of 16 child-caregiver pairs). A total of 24 weekly treatment sessions lasting up to 90 minutes each will be held over 6 months. Family-based behavioral treatment is a manualized, group intervention for children with obesity and their caregivers that incorporate participant-driven goal-based changes in diet and physical activity, and a variety of interactive educational session topics and behavioral support for reaching goals. A private weigh-in for children and caregivers will be conducted at each session. Sessions will begin with check-in with each family about weekly goal progress, after which the caregivers and children will split into separate groups for session-specific content including educational material tailored to nutrition, eating, and activity. The final portion of group session will involve children and caregivers merging in one group to share learning experiences and engage in collaborative goal-setting for the upcoming week(s). After the six month family-based behavioral intervention, baseline measures will be reassessed as well as overall program adherence. Program adherence will be evaluated using weekly program attendance and the number of days dietary/physical activity self-monitoring logs were completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a BMI ≥ 85th percentile\n2. Are ≥8 and ≤12 years old at the beginning of treatment\n3. Can read, write, and speak English, along with their parent\n4. Plan to stay living within the local area during the study period\n5. Have a consenting parent who can commit to all study procedures and provide reliable travel.\n\n * Siblings will be eligible for study inclusion if they meet the above criteria and will be allowed to use the same participating parent (sibling effects would then be addressed in statistical analyses).\n\nExclusion Criteria:\n\n1. Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight\n2. Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program\n3. Have been diagnosed with an intellectual disability or traumatic brain injury\n4. Have medical contraindications to physical activity.'}, 'identificationModule': {'nctId': 'NCT03329300', 'acronym': 'CARTWHEEL', 'briefTitle': 'Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management', 'orgStudyIdInfo': {'id': 'P30DK056336-16-PF-001'}, 'secondaryIdInfos': [{'id': 'P30DK056336-16', 'link': 'https://reporter.nih.gov/quickSearch/P30DK056336-16', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All participants', 'description': 'Family-based Behavioral Treatment (FBT)', 'interventionNames': ['Behavioral: Family-based Behavioral Treatment (FBT)']}], 'interventions': [{'name': 'Family-based Behavioral Treatment (FBT)', 'type': 'BEHAVIORAL', 'description': 'Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Marissa Gowey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham Department of Pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nutrition Obesity Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marissa Gowey', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}