Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06158204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Metabolic & Mental Health in Female Healthcare Shift Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000073397', 'term': 'Occupational Stress'}], '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'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visceral fat percentage', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Change in visceral fat as a percentage of total fat mass as measured by dual x-ray absorptiometry. Lower values are optimal.'}, {'measure': 'Mental Quality of Life', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Research ANd Development (RAND) Short Form-12 will assess mental quality of life (Range 0-100; 100 is optimal).'}, {'measure': 'Physical Quality of Life', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Research ANd Development (RAND) Short Form-12 will assess physical quality of life (Range 0-100; 100 is optimal).'}], 'secondaryOutcomes': [{'measure': 'Fasting serum triglycerides', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Phlebotomy will be obtained while fasted 8+ hours and triglycerides will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.'}, {'measure': 'Fasting alanine aminotransferase (ALT)', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Phlebotomy will be obtained while fasted 8+ hours and alanine aminotransferase (ALT) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.'}, {'measure': 'Fasting serum blood glucose', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Phlebotomy will be obtained while fasted 8+ hours and blood glucose will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.'}, {'measure': 'Fasting serum low-density lipoproteins (LDL)', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Phlebotomy will be obtained while fasted 8+ hours and low-density lipoproteins (LDL) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.'}, {'measure': 'Sleep - accelerometry', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Average minutes of total daily sleep.'}, {'measure': 'Total caloric intake', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Four 24-hour dietary recalls will be obtained every four weeks and entered into the and analyzed in the Nutrition Data System for Research (NDSR).'}, {'measure': 'Total protein intake', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': 'Four 24-hour dietary recalls will be obtained every four weeks and entered into the and analyzed in the Nutrition Data System for Research (NDSR).'}, {'measure': 'Stool microbiome composition', 'timeFrame': 'Change from 0-8 weeks; 8-16 weeks', 'description': '16S changes in microbiome alpha diversity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['circadian rhythm', 'protein', 'shift work', 'female', 'sleep'], 'conditions': ['Sleep, Inadequate', 'Overweight and Obesity', 'Work Related Stress', 'Healthy Lifestyle']}, 'referencesModule': {'references': [{'pmid': '41228416', 'type': 'DERIVED', 'citation': 'Robinson LA, Lennon S, Pegel AR, Strickland KP, Feeley CA, Watts SO, J Van Der Pol W, Roberts MD, Greene MW, Fruge AD. A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic and Mental Health in Female Healthcare Night-Shift Workers. Nutrients. 2025 Oct 24;17(21):3342. doi: 10.3390/nu17213342.'}]}, 'descriptionModule': {'briefSummary': 'Circadian rhythm disruption caused by shift work alters metabolic and hormonal pathways, which accelerates chronic disease onset, leading to decreased quality and quantity of life. Preclinical studies indicate that optimizing nutrient and sleep/rest timing can mitigate these effects.\n\nFemale nightshift healthcare workers will be recruited to participate in a randomized crossover trial in which participants will be expected to follow the prescribed lifestyle intervention for eight weeks during the first or second eight-week periods of the study.', 'detailedDescription': 'Clinical assessments will include DEXA, phlebotomy, questionnaires, and stool collection, which will be completed at weeks 0, 8, and 16 to assess changes in metabolic health and quality of life. Four days of 24-hour dietary recalls will be collected at baseline, and weeks 4, 8, 12, and 16. Garmin Vivofit4 activity trackers will be provided to all participants at baseline, and participants will be reminded to sync the devices once weekly at minimum.\n\nDuring the 8-week intervention phase, participants will receive guidance on when and what to eat and when to sleep and be physically active. Additionally, participants will be provided with whey protein isolate powder and grain-based snack bars to be consumed primarily during work shifts. Lean body mass (kg) will be used to prescribe total caloric (\\~30kcal/kg lean mass) and protein (2g/kg lean mass) needs and sleep/rest goals will be 6-8 hours per 24 hour "day."'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18-50 years old\n* BMI between 27 and 40 kg/m2\n* \\>6 months in current predominantly night shift (average 30+ hours/week) schedule\n* Can read and speak English\n* Willing to correspond with study staff using smartphone technologies\n\nExclusion Criteria:\n\n* Pregnant or undergoing hormonal treatment for fertility\n* Major changes in any prescription medications within 3 months\n* Major surgeries in last 3 months\n* Diagnosis of Type 2 Diabetes or other major endocrine diseases\n* Diagnosed food allergies or significant dietary limitations\n* Currently engaged in intensive weight loss program\n* Minimal medically necessary radiation exposure within the last year'}, 'identificationModule': {'nctId': 'NCT06158204', 'briefTitle': 'Improving Metabolic & Mental Health in Female Healthcare Shift Workers', 'organization': {'class': 'OTHER', 'fullName': 'Auburn University'}, 'officialTitle': 'A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers', 'orgStudyIdInfo': {'id': '23-496 MR 2310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate intervention', 'description': 'Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only', 'interventionNames': ['Behavioral: Lifestyle Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed intervention', 'description': 'Participants will receive the 8-week intervention after 8 weeks of observation-only', 'interventionNames': ['Behavioral: Lifestyle Intervention']}], 'interventions': [{'name': 'Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive guidance on when and what to eat and when to sleep and be physically active. Additionally, participants will be provided with whey protein isolate powder to be mixed with water and grain-based snack bars to be consumed primarily during work shifts. Lean body mass (kg) will be used to prescribe total caloric (\\~30kcal/kg lean mass) and protein (2g/kg lean mass) needs and sleep/rest goals will be 6-8 hours per 24 hour "day"', 'armGroupLabels': ['Delayed intervention', 'Immediate intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36849', 'city': 'Auburn', 'state': 'Alabama', 'country': 'United States', 'facility': 'Auburn University', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}], 'overallOfficials': [{'name': 'Andrew D Frugé, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auburn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Auburn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Fruge', 'investigatorAffiliation': 'Auburn University'}}}}