Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity; Sleep, Inadequate; Work Related Stress; Healthy Lifestyle
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT06158204
• Lead Sponsor: Auburn University

Brief Summary

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.

Female 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.

Detailed Description

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.

During 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."

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Study Start: 2024-01-02
• Primary Completion: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Female
• 18-50 years old
• BMI between 27 and 40 kg/m2
• >6 months in current predominantly night shift (average 30+ hours/week) schedule
• Can read and speak English
• Willing to correspond with study staff using smartphone technologies

Exclusion Criteria

• Pregnant or undergoing hormonal treatment for fertility
• Major changes in any prescription medications within 3 months
• Major surgeries in last 3 months
• Diagnosis of Type 2 Diabetes or other major endocrine diseases
• Diagnosed food allergies or significant dietary limitations
• Currently engaged in intensive weight loss program
• Minimal medically necessary radiation exposure within the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Delayed intervention	Lifestyle Intervention	Participants will receive the 8-week intervention after 8 weeks of observation-only
Immediate intervention	Lifestyle Intervention	Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only

Primary Outcome Measures

Name	Time	Method
Visceral fat percentage	Change from 0-8 weeks; 8-16 weeks	Change in visceral fat as a percentage of total fat mass as measured by dual x-ray absorptiometry. Lower values are optimal.
Mental Quality of Life	Change from 0-8 weeks; 8-16 weeks	Research ANd Development (RAND) Short Form-12 will assess mental quality of life (Range 0-100; 100 is optimal).
Physical Quality of Life	Change from 0-8 weeks; 8-16 weeks	Research ANd Development (RAND) Short Form-12 will assess physical quality of life (Range 0-100; 100 is optimal).

Secondary Outcome Measures

Name	Time	Method
Sleep - accelerometry	Change from 0-8 weeks; 8-16 weeks	Average minutes of total daily sleep.
Stool microbiome composition	Change from 0-8 weeks; 8-16 weeks	16S changes in microbiome alpha diversity.
Fasting alanine aminotransferase (ALT)	Change from 0-8 weeks; 8-16 weeks	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.
Total protein intake	Change from 0-8 weeks; 8-16 weeks	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).
Fasting serum low-density lipoproteins (LDL)	Change from 0-8 weeks; 8-16 weeks	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.
Fasting serum triglycerides	Change from 0-8 weeks; 8-16 weeks	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.
Fasting serum blood glucose	Change from 0-8 weeks; 8-16 weeks	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.
Total caloric intake	Change from 0-8 weeks; 8-16 weeks	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).

Trial Locations

Locations (1)

Auburn University; 🇺🇸 Auburn, Alabama, United States