Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-03 @ 6:32 AM
Study NCT ID:
NCT01508793
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2012-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sleep Duration', 'timeFrame': 'Baseline, 2-weeks, and 2-months', 'description': 'Measured with actigraphy'}, {'measure': 'Change in Dietary Intake', 'timeFrame': 'Baseline, 2-weeks, and 2-months', 'description': 'Measured using 24-hour dietary recalls (2 weekday and 1 weekend day)'}], 'secondaryOutcomes': [{'measure': 'Change in the Reinforcing Value of Food', 'timeFrame': 'Baseline, 2-weeks, and 2-months', 'description': 'Measured using a computer paradigm, the Behavioral Choice Task'}, {'measure': 'Change in activity', 'timeFrame': 'Baseline, 2-week, and 2-month', 'description': 'Physical and sedentary activities assessed using accelerometers and self-report'}, {'measure': 'Change in zBMI', 'timeFrame': 'Baseline, 2-week, and 2-month', 'description': 'Based on measured height and weight'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep', 'Obesity', 'Children', 'Eating behaviors', 'Activity'], 'conditions': ['Sleep', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 8-11 years old\n* BMI for age and gender \\> 10th percentile (but no greater than 100% overweight)\n* Sleep 9.5 hours or less nightly\n* Attend elementary school\n* Like at least 1 food used in the reinforcement paradigm\n* Able to understand and complete the reinforcement paradigm\n\nExclusion Criteria:\n\n* Existence of a diagnosable parasomnia, sleep disordered breathing\n* Medical or psychiatric condition that could influence sleep or weight\n* Inability to complete study materials, including diagnosed disabilities\n* Dietary restrictions/allergies to foods used in the study that preclude them from study participation'}, 'identificationModule': {'nctId': 'NCT01508793', 'briefTitle': "Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors", 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': "Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors", 'orgStudyIdInfo': {'id': 'R01HL092910', 'link': 'https://reporter.nih.gov/quickSearch/R01HL092910', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Optimize Sleep', 'interventionNames': ['Behavioral: Optimize Sleep']}], 'interventions': [{'name': 'Optimize Sleep', 'type': 'BEHAVIORAL', 'description': 'Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention', 'armGroupLabels': ['Optimize Sleep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Obesity Research and Education', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Chantelle N Hart, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Temple University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}