Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Auburn University

Status: Active, not recruiting

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

Treatments: Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06158204

23-496 MR 2310

Details and patient eligibility

About

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.

Full 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."

Enrollment: 13 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Immediate intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Intervention

Delayed intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle Intervention