Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05853393
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2023-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tween Sleep Patterns, Appetite Control, and Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], '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': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of eating in the absence of hunger (EAH) episodes', 'timeFrame': 'Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks', 'description': 'Eating events where pre-meal hunger is less than 35 on a 100 point visual analogue scale, as reported on smartphone surveys that are completed multiple times a day over a 2 week period.'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale rating of hunger', 'timeFrame': 'Multiple measurements per day for 2 weeks', 'description': 'Collected via EMA'}, {'measure': 'Visual analogue scale rating of fullness', 'timeFrame': 'Multiple measurements per day for 2 weeks', 'description': 'Collected via EMA'}, {'measure': 'Visual analogue scale rating of desire to eat', 'timeFrame': 'Multiple measurements per day for 2 weeks', 'description': 'Collected via EMA'}, {'measure': 'Child appetitive traits', 'timeFrame': 'At enrollment', 'description': 'Measured by parent report questionnaire (Child Eating Behavior Questionnaire)'}, {'measure': 'Child mindful eating', 'timeFrame': 'At enrollment', 'description': 'Measured by child self report questionnaire (Mindful Eating Questionnaire)'}, {'measure': 'Child eating motivations', 'timeFrame': 'At enrollment', 'description': 'Measured by child self report questionnaire (Palatable Eating Motives Questionnaire)'}, {'measure': 'Child restrained and disinhibited eating', 'timeFrame': 'At enrollment', 'description': 'Measured by child self report questionnaire (Dutch Eating Behavior Questionnaire)'}, {'measure': 'Sleep duration', 'timeFrame': 'Daily over 2 weeks', 'description': 'Measured by actigraphy'}, {'measure': 'Sleep maintenance efficiency', 'timeFrame': 'Daily over 2 weeks', 'description': 'Measured by actigraphy'}, {'measure': 'Body mass index z-score', 'timeFrame': 'At enrollment', 'description': 'Calculated from measured height and weight'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'eating in the absence of hunger', 'eating', 'preadolescent', 'rural', 'actigraphy', 'ecological momentary assessment'], 'conditions': ['Child Obesity', 'Eating Behavior', 'Sleep']}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn about how children's sleep is related to their eating behaviors the next day, and to learn about factors that relate to eating behaviors and sleep health that are specific to preadolescent children living in rural communities.", 'detailedDescription': 'The aims of this study are to a) describe the prevalence and characteristics of eating in the absence of hunger (EAH) in rural preadolescent children using a novel methodology, ecological momentary assessment (EMA); b) to examine the within-person temporal relationship between daily changes in sleep health (i.e., duration and quality) and EAH; and c) examine associations between family, child, and environmental characteristics, sleep, and eating behaviors in rural preadolescent children. Parent-child dyads will participate in the study via remote data collection methods including Zoom interviews, online surveys, EMA survey completed by smartphone, and actigraphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 8-12 years old and a parent/guardian (n=64 parent-child dyads for a total of 128 individuals)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Child Inclusion Criteria:\n\n1. Age 8 to 12 years\n2. Primary residence is in a rural ZIP code in the United States, as defined by Health Resources \\& Services Administration\n3. BMI for age ≥ 85th percentile OR BMI ≥ 15th percentile plus at least one biological parent with BMI ≥ 25 kg/m2\n4. Able to read and answer questions in English\n\nParent Inclusion criteria:\n\n1. Parent or caregiver of an eligible child\n2. Age 18 years or older\n3. Able to read and answer questions in English\n\nExclusion Criteria:\n\n1. Any medical condition that significantly impacts eating, sleep, growth, or ability to operate the mEMA smartphone platform (e.g., eating disorder, Type I diabetes, blindness) (Child participants only)\n2. Unable to connect to a Zoom session via internet or cell-phone data from home\n3. Unable to receive and sign for package with study supplies'}, 'identificationModule': {'nctId': 'NCT05853393', 'acronym': 'TweenSPACE', 'briefTitle': 'Tween Sleep Patterns, Appetite Control, and Environment', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])', 'orgStudyIdInfo': {'id': 'STUDY00020663'}}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennyslvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Emily E Hohman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified participant data may be made available at the conclusion of the study by request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Professor', 'investigatorFullName': 'Emily Hohman', 'investigatorAffiliation': 'Penn State University'}}}}