Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, circadian rhythm, protein, shift work, female