Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158204
• Other study ID #: 23-496 MR 2310
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Auburn University
• Contact: Andrew D Frugé, PhD
• Phone: 3348448433
• Email: adf0003[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle
• Occupational Stress
• Overweight
• Overweight and Obesity
• Sleep Deprivation
• Work Related Stress

Intervention

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"

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sleep - accelerometry	Average minutes of total daily sleep.	Change from 0-8 weeks; 8-16 weeks
Secondary	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
Secondary	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
Secondary	Stool microbiome composition	16S changes in microbiome alpha diversity.	Change from 0-8 weeks; 8-16 weeks