Improving Metabolic & Mental Health in Female Healthcare Shift Workers

A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity; Healthy Lifestyle; Work Related Stress; Sleep, Inadequate
• Intervention / Treatment: Behavioral: Lifestyle Intervention

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate intervention; Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only	Behavioral: Lifestyle Intervention; 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"
Active Comparator: Delayed intervention; Participants will receive the 8-week intervention after 8 weeks of observation-only	Behavioral: Lifestyle Intervention; 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"

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Auburn University
• Investigators: Principal Investigator: Andrew D Frugé, PhD, Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): June 19, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: sleep; female; circadian rhythm; protein; shift work
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Sleep Wake Disorders; Dyssomnias; Stress, Psychological; Occupational Diseases; Occupational Stress; Overweight; Sleep Deprivation
• Other Study ID Numbers: 23-496 MR 2310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No