Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05388318
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with 2 groups (intervention and control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Telephone Montreal Cognitive Assessment', 'timeFrame': '8 weeks', 'description': 'T-MoCA, a measure of cognitive function'}, {'measure': 'Every Day Cognition-12', 'timeFrame': '8 weeks', 'description': 'ECOG-12, a measure of cognitive function'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale- 10', 'timeFrame': '8 weeks', 'description': 'PSS-10, a measure of perceived stress'}, {'measure': 'Rapid Eating Assessment for Participants', 'timeFrame': '8 weeks', 'description': 'REAPS, a measure of eating behaviors'}, {'measure': 'Creature of Habit Scale', 'timeFrame': '8 weeks', 'description': 'COHS, a measure of habitual behavior'}, {'measure': 'Three-Factor Eating Questionnaire-Revised', 'timeFrame': '8 weeks', 'description': 'TFEQ, a measure of eating behaviors'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8 weeks', 'description': 'PSQI, a measure of sleep quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Midlife Obese Adults With Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40-59 years old\n* experiencing memory loss\n* BMI 30-45.9\n* PSS-4 score ≥5\n* access to smartphone, zoom, and wifi\n* lives in United States\n\nExclusion Criteria:\n\n* diabetes\n* pregnant,\n* neurological disorder\n* eating disorder within last 20 years\n* In current weight loss program\n* previously had bariatric surgery\n* works a night shit\n* health condition not conducive to nightly fasting'}, 'identificationModule': {'nctId': 'NCT05388318', 'acronym': 'GetSmart', 'briefTitle': 'Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults', 'orgStudyIdInfo': {'id': '00015014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolonged nightly fasting (PNF)', 'interventionNames': ['Behavioral: Prolonged nightly fasting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education Control (HEC)', 'interventionNames': ['Behavioral: Health Education Control']}], 'interventions': [{'name': 'Prolonged nightly fasting', 'type': 'BEHAVIORAL', 'description': '14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.', 'armGroupLabels': ['Prolonged nightly fasting (PNF)']}, {'name': 'Health Education Control', 'type': 'BEHAVIORAL', 'description': 'Weekly health education video viewing related to general health topics', 'armGroupLabels': ['Health Education Control (HEC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}