Lifestyle Intervention for Night Shift Health Issues

Overseen By Andrew D Frugé, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Pregnancy, Diabetes, Endocrine diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andrew D Frugé, PhD

Principal Investigator

Auburn University

Eligibility Criteria

This trial is for female healthcare workers aged 18-50 with a BMI of 27-40 who work night shifts. They must have been on this schedule for over 6 months, be able to use smartphone tech, and speak English. It's not for those pregnant, on hormonal fertility treatments, with recent medication changes or surgeries, diagnosed with major endocrine diseases or food allergies, in weight loss programs, or exposed to radiation.

Inclusion Criteria

Willing to correspond with study staff using smartphone technologies

Have been in a predominantly night shift schedule for more than 6 months

I am female.

Exclusion Criteria

I am currently pregnant or receiving hormonal fertility treatments.

I haven't changed my prescription medications in the last 3 months.

I have not had any major surgeries in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants follow a prescribed lifestyle intervention including guidance on nutrition, sleep, and physical activity for 8 weeks

8 weeks

Clinical assessments at weeks 0 and 8

Observation

Participants are observed without intervention to assess changes in metabolic health and quality of life

8 weeks

Clinical assessments at weeks 8 and 16

Follow-up

Participants are monitored for safety and effectiveness after the intervention and observation phases

4 weeks

Treatment Details

Interventions

• Lifestyle Intervention

Trial Overview The study tests a lifestyle intervention aimed at improving metabolic and mental health disrupted by shift work. Participants will follow the program for eight weeks during one of two periods in this randomized crossover trial.

Participant Groups

Group I: Immediate intervention Experimental Treatment 1 Intervention

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

Group II: Delayed intervention Active Control 1 Intervention

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

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+