Improving Metabolic & Mental Health in Female Healthcare Shift Workers

NCT06158204 | Active Not Recruiting

• 1 other identifier: 23-496 MR 2310
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep, Inadequate; Overweight and Obesity; Work Related Stress; Healthy Lifestyle

Keywords

circadian rhythm; protein; shift work; female; sleep

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Fasting serum triglycerides

  Change from 0-8 weeks; 8-16 weeks

• Fasting alanine aminotransferase (ALT)

  Change from 0-8 weeks; 8-16 weeks

• Fasting serum blood glucose

  Change from 0-8 weeks; 8-16 weeks

• Fasting serum low-density lipoproteins (LDL)

  Change from 0-8 weeks; 8-16 weeks

• Sleep - accelerometry

  Change from 0-8 weeks; 8-16 weeks

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only

Behavioral: Lifestyle Intervention

Delayed intervention

ACTIVE COMPARATOR

Participants will receive the 8-week intervention after 8 weeks of observation-only

Behavioral: Lifestyle Intervention

Interventions

Lifestyle Intervention BEHAVIORAL

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"

Delayed intervention; Immediate intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (1)

• 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.

  PMID: 41228416 DERIVED

MeSH Terms

Conditions

Sleep Deprivation; Overweight; Obesity; Occupational Stress

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Andrew D Frugé, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 2, 2024
• Primary Completion: June 19, 2024
• Study Completion: March 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)