Viewing Study NCT03947918


Ignite Creation Date: 2025-12-25 @ 4:30 AM
Ignite Modification Date: 2026-03-05 @ 3:10 PM
Study NCT ID: NCT03947918
Status: TERMINATED
Last Update Posted: 2025-04-25
First Post: 2019-02-19
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Summertime: Kids in Motion
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'suzanna.martinez@ucsf.edu', 'phone': '415-476-2300', 'title': 'Suzanna Martinez', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'No adverse events occurred during the duration of the study (1 year, 9 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Differences in Sleep Duration by Sleep Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '.8', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Differences in Physical Activity (Outcome) by Short and Long Sleep Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '20', 'groupId': 'OG000'}, {'value': '30', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week', 'description': 'Physical activity will be measured with accelerometers. Accelerometer data will be used to calculate moderate- to vigorous-intensity physical activity (MVPA; minutes). Activity counts were summed for each 24-hour period categorized into moderate to vigorous levels of physical activity according to the previously established thresholds. Moderate physical activity was set at 0.04 \\< AEE \\< 0.10 kcal.kg-1.min-1 or 3.0 \\< PAR \\< 6.0, reflective of medium exertion in the standing position. Vigorous physical activity was set at AEE \\> 0.10 kcal.kg-1.min-1 or PAR \\> 6.0, reflective of activities at a high level of exertion in the standing position. Moderate-intensity and vigorous-intensity physical activity were combined and expressed as minutes spent in MVPA.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'minutes of daily moderate to vigorous physical activity'}, {'type': 'PRIMARY', 'title': 'Differences in Carbohydrate Intake by Long and Short Sleep Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '1312', 'spread': '484', 'groupId': 'OG000'}, {'value': '1526', 'spread': '871', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Sleep duration will be measured with accelerometers. Dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Daily sugar intake (grams) will be calculated.', 'unitOfMeasure': 'kcals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'average carbohydrate intake'}, {'type': 'PRIMARY', 'title': 'Differences in Added Sugar Intake by Long and Short Sleep Condition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '38', 'groupId': 'OG000'}, {'value': '65', 'spread': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Sleep duration will be measured with accelerometers. Dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Daily sugar intake (grams) will be calculated.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Sleep Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.91', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '7.56', 'spread': '3.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline measurement (one time point)', 'description': "Mothers' bedtimes and wakeup times will be assessed by self report.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Mothers' reported sleep."}, {'type': 'SECONDARY', 'title': "Sleep Hygiene Related to Children's Sleep Schedules.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'OG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline measurement (one time point)', 'description': 'Sleep hygiene will be assessed by whether the child shares a bed, shares a room and a bed, shares a room (but not a bed), or does not any. Child sleep schedule (bedtime) will be measured by parent report.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who watched TV in bed as a nighttime routine at least once per week.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Short Sleep', 'description': 'This condition required sleeping for less than 8 hours per night for one week.'}, {'id': 'FG001', 'title': 'Long Sleep', 'description': 'This condition required sleeping for more than 10 hours per night for one week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment started on June 17, 2018 and ended March 9, 2020. Participants were recruited from local San Francisco nonprofit organizations, after school programs, local community events, a federally-qualified community health center and UCSF health clinics.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Short Sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'BG001', 'title': 'Long Sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights\n\nShort sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.\n\nLong sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'spread': '1.09', 'groupId': 'BG000'}, {'value': '9.74', 'spread': '.70', 'groupId': 'BG001'}, {'value': '9.71', 'spread': '.92', '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': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'San Francisco Bay Area participants based on eligibility requirement', 'unitOfMeasure': 'participants'}, {'title': 'BMI z-score', 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'spread': '1.28', 'groupId': 'BG000'}, {'value': '2.17', 'spread': '1.21', 'groupId': 'BG001'}, {'value': '1.83', 'spread': '1.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI z-score of 0 represents the population mean. Clinical cut-offs for overweight risk: BMI z-score greater than +1.0; overweight: BMI z-score greater than +2.0; obese: BMI z-score greater than +3.0.', 'unitOfMeasure': 'BMI z-score: 0 is the population average', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sleep duration', 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'spread': '.73', 'groupId': 'BG000'}, {'value': '10.32', 'spread': '1.68', 'groupId': 'BG001'}, {'value': '9.99', 'spread': '1.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Sleep duration was assessed by maternal report of child's usual time to bed and time to wake up.", 'unitOfMeasure': 'hours per night', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-03', 'size': 241122, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-25T21:16', 'hasProtocol': True}, {'date': '2020-06-16', 'size': 29976, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-25T20:58', 'hasProtocol': False}, {'date': '2019-03-18', 'size': 2213836, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-23T14:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Three-week study includes:\n\nWeek 1 - all children get usual sleep Tuesday-Friday.\n\nWeek 2 - children are randomized to getting no more than 8 hours or at least 10 hours of sleep (Tuesday-Friday).\n\nWeek 3 - children crossover to the opposite sleep condition (Tuesday-Friday).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': "Due to challenges regarding COVID-19, it was not possible to reach the study's target sample size.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2019-02-19', 'resultsFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-23', 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Sleep Duration by Sleep Condition.', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers.'}, {'measure': 'Differences in Physical Activity (Outcome) by Short and Long Sleep Condition.', 'timeFrame': 'One week', 'description': 'Physical activity will be measured with accelerometers. Accelerometer data will be used to calculate moderate- to vigorous-intensity physical activity (MVPA; minutes). Activity counts were summed for each 24-hour period categorized into moderate to vigorous levels of physical activity according to the previously established thresholds. Moderate physical activity was set at 0.04 \\< AEE \\< 0.10 kcal.kg-1.min-1 or 3.0 \\< PAR \\< 6.0, reflective of medium exertion in the standing position. Vigorous physical activity was set at AEE \\> 0.10 kcal.kg-1.min-1 or PAR \\> 6.0, reflective of activities at a high level of exertion in the standing position. Moderate-intensity and vigorous-intensity physical activity were combined and expressed as minutes spent in MVPA.'}, {'measure': 'Differences in Carbohydrate Intake by Long and Short Sleep Condition.', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Sleep duration will be measured with accelerometers. Dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Daily sugar intake (grams) will be calculated.'}, {'measure': 'Differences in Added Sugar Intake by Long and Short Sleep Condition.', 'timeFrame': 'One week', 'description': 'Sleep duration will be measured with accelerometers. Eating/dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Sleep duration will be measured with accelerometers. Dietary intake (outcome) will be assessed on Thursdays and Fridays using 24-hour recalls using Nutrition Data System for Research. Daily sugar intake (grams) will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Maternal Sleep Duration', 'timeFrame': 'Baseline measurement (one time point)', 'description': "Mothers' bedtimes and wakeup times will be assessed by self report."}, {'measure': "Sleep Hygiene Related to Children's Sleep Schedules.", 'timeFrame': 'Baseline measurement (one time point)', 'description': 'Sleep hygiene will be assessed by whether the child shares a bed, shares a room and a bed, shares a room (but not a bed), or does not any. Child sleep schedule (bedtime) will be measured by parent report.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '23729925', 'type': 'BACKGROUND', 'citation': 'Beebe DW, Simon S, Summer S, Hemmer S, Strotman D, Dolan LM. Dietary intake following experimentally restricted sleep in adolescents. Sleep. 2013 Jun 1;36(6):827-34. doi: 10.5665/sleep.2704.'}, {'pmid': '17056861', 'type': 'BACKGROUND', 'citation': 'Taheri S. The link between short sleep duration and obesity: we should recommend more sleep to prevent obesity. Arch Dis Child. 2006 Nov;91(11):881-4. doi: 10.1136/adc.2005.093013.'}, {'pmid': '22911935', 'type': 'BACKGROUND', 'citation': "Rendall MS, Weden MM, Fernandes M, Vaynman I. Hispanic and black US children's paths to high adolescent obesity prevalence. Pediatr Obes. 2012 Dec;7(6):423-35. doi: 10.1111/j.2047-6310.2012.00080.x. Epub 2012 Aug 21."}, {'pmid': '19333745', 'type': 'BACKGROUND', 'citation': 'Singh GK, Kogan MD, Yu SM. Disparities in obesity and overweight prevalence among US immigrant children and adolescents by generational status. J Community Health. 2009 Aug;34(4):271-81. doi: 10.1007/s10900-009-9148-6.'}, {'pmid': '26547544', 'type': 'BACKGROUND', 'citation': "Martinez SM, Thompson-Lastad A. Latino Parents' Insight on Optimal Sleep for Their Preschool-Age Child: Does Context Matter? Acad Pediatr. 2015 Nov-Dec;15(6):636-43. doi: 10.1016/j.acap.2015.07.003. Epub 2015 Sep 26."}]}, 'descriptionModule': {'briefSummary': "This is a 3-week randomized crossover study to determine the effect of the prior night's sleep duration on energy-balance related behaviors of diet and physical activity the following day. In Week 1, child participants will sleep their usual amount. In week 2, participants will be randomized to either a sleep restricted or a healthy sleep condition for 4 nights. In week 3, participants will cross over to the opposite sleep condition for 4 nights.", 'detailedDescription': "Individuals of Mexican descent comprise the largest proportion of the Latino population in the United States and they suffer high rates of obesity. Short sleep is a risk factor for obesity. An improved understanding of the underlying behavioral mechanisms by which short sleep duration may impact obesity among Mexican American children is critical to prevent and/or reduce obesity and chronic disease in this population. This research will focus on behavioral mechanisms (i.e., diet and physical activity) that link sleep duration to obesity. Mexican American 8-10-year-olds will participate in a 3-week crossover study to examine: 1) contextual factors (i.e., bedtime routines, sleep hygiene, familism) that may impact sleep; and 2) the impact of prior night's sleep duration on diet and physical activity the subsequent day. This research design will make it possible to examine whether sufficient sleep is protective of energy balance (e.g., healthful dietary intake/patterns and physical activity) as well as contextual factors related sleep."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mexican American child-mother pairs which will include: child 8-10 years old; mother/female guardian; English/Spanish speakers; mobile phone user.\n\nExclusion Criteria:\n\n* Children with major illnesses and/or with sleep apnea for which children\n* In families where 2 children are eligible for participation, a child will be selected at random to participate in the study.\n* The investigators will exclude fathers from this study for reasons due to statistical power'}, 'identificationModule': {'nctId': 'NCT03947918', 'briefTitle': 'Summertime: Kids in Motion', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Sleep Duration and Risk for Obesity in Mexican American Children', 'orgStudyIdInfo': {'id': '1K01HL129087-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K01HL129087-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short sleep', 'description': 'No more than 8 hours of sleep for 4 consecutive nights.', 'interventionNames': ['Behavioral: Short sleep', 'Behavioral: Long sleep']}, {'type': 'EXPERIMENTAL', 'label': 'Long sleep', 'description': 'At least 10 hours of sleep for 4 consecutive nights', 'interventionNames': ['Behavioral: Short sleep', 'Behavioral: Long sleep']}], 'interventions': [{'name': 'Short sleep', 'type': 'BEHAVIORAL', 'otherNames': ['Restricted sleep'], 'description': 'Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders.', 'armGroupLabels': ['Long sleep', 'Short sleep']}, {'name': 'Long sleep', 'type': 'BEHAVIORAL', 'otherNames': ['Healthy sleep'], 'description': 'Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders.', 'armGroupLabels': ['Long sleep', 'Short sleep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Suzanna M Martinez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}