Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT06549868
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2024-07-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Yoga to Reduce Chaos and Improve Preschooler Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention adherence', 'timeFrame': '4 weeks', 'description': 'Number of yoga sessions completed Percent of prescribed sessions completed'}, {'measure': 'Household chaos', 'timeFrame': 'at week 1, week 5, and week 10', 'description': 'Measured using Chaos, Hubbub, and Order Scale (CHAOS) at enrollment, crossover point, and study completion. A lower CHAOS score post-intervention would indicate an improvement in household chaos.'}], 'secondaryOutcomes': [{'measure': 'Child sleep duration', 'timeFrame': 'at week 1, week 5, and week 10', 'description': 'nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion'}, {'measure': 'Parent sleep duration', 'timeFrame': '1 week at week 1, week 5, and week 10', 'description': 'nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion'}, {'measure': 'Parent sleep quality', 'timeFrame': '1 week at week 1, week 5, and week 10', 'description': 'nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion'}, {'measure': 'Child sleep quality', 'timeFrame': '1 week at week 1, week 5, and week 10', 'description': 'nightly sleep measured by waist-worn accelerometer'}, {'measure': 'Child sleep quality', 'timeFrame': '1 week at week 1, week 5, and week 10', 'description': "measured by Children's Sleep Habits Questionnaire (CSHQ; scored using mean and standard deviation of survey items. A higher CSHQ mean score indicates worse sleep quality)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'children', 'preschool', 'yoga', 'parents', 'household chaos'], 'conditions': ['Sleep, Inadequate', 'Sleep']}, 'descriptionModule': {'briefSummary': 'The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:\n\nWill families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.\n\nParticipants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will \\"cross over\\" to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 2.0-5.9 years of age and their self-identified primary parent/guardian\n\nExclusion Criteria:\n\n\\- Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine'}, 'identificationModule': {'nctId': 'NCT06549868', 'briefTitle': 'Using Yoga to Reduce Chaos and Improve Preschooler Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Ohio University College of Osteopathic Medicine'}, 'officialTitle': 'Using Yoga to Reduce Chaos and Improve Preschooler Sleep', 'orgStudyIdInfo': {'id': '19-X-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga', 'description': 'Participants will be asked to follow a yoga-based bedtime routine for 4 weeks', 'interventionNames': ['Behavioral: Yoga-based bedtime routine']}, {'type': 'OTHER', 'label': 'Story', 'description': 'Waitlist control arm. Participants will complete a 4-week control period upon randomization. After this control period is completed, they will crossover into the intervention group and follow the same 4 week intervention as the yoga group.', 'interventionNames': ['Behavioral: Yoga-based bedtime routine']}], 'interventions': [{'name': 'Yoga-based bedtime routine', 'type': 'BEHAVIORAL', 'description': "Dyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book.\n\nAt week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period.", 'armGroupLabels': ['Story', 'Yoga']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio University', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is a pilot study for a planned full-scale intervention'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emily Guseman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emily Guseman', 'investigatorAffiliation': 'Ohio University College of Osteopathic Medicine'}}}}