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NCT06158204 | ACTIVE NOT RECRUITING | Sleep, Inadequate


Improving Metabolic & Mental Health in Female Healthcare Shift Workers
Sponsor:

Auburn University

Information provided by (Responsible Party):

Andrew Fruge

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.

Condition or disease

Sleep, Inadequate

Overweight and Obesity

Work Related Stress

Healthy Lifestyle

Intervention/treatment

Lifestyle Intervention

Phase

NA

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
Estimated Enrollment : 13 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers
Actual Study Start Date : 2024-01-02
Estimated Primary Completion Date : 2024-06-19
Estimated Study Completion Date : 2025-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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

Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Location Details

NCT06158204


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Locations


Not yet recruiting

United States, Albama

Auburn University

Auburn, Albama, United States, 36849

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