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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adjusting eating and resting times can reduce health issues caused by night shifts. It focuses on female healthcare workers who have worked night shifts for over six months. Participants will follow an eight-week lifestyle change program (Lifestyle Intervention) either immediately or after an observation period. The trial seeks women who believe night shifts have affected their health, particularly those with a BMI between 27 and 40, and who do not have conditions like Type 2 Diabetes. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle changes that may improve health for night shift workers.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you've had major changes in any prescription medications in the last 3 months, you may not be eligible to participate.

What prior data suggests that this lifestyle intervention is safe?

Research has shown that night shift workers can easily manage changes in eating schedules and sleep patterns. Studies have found that these changes can improve health without causing major side effects. For instance, one study found that participants who followed a specific lifestyle plan had better eating and recovery habits, indicating that the plan was safe and manageable for most people.

Another review of diet changes for night shift workers showed that these strategies could help with weight loss and increase physical activity. These benefits were achieved without any major negative effects, suggesting that the lifestyle changes are generally safe. Overall, these findings suggest that joining this lifestyle intervention trial is unlikely to pose significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for night shift health issues because it focuses on behavior and habit changes rather than medications or supplements. Most treatments for health problems associated with night shifts typically involve pharmaceuticals or sleep aids. However, this intervention aims to improve health by adjusting lifestyle factors like diet, exercise, and sleep hygiene, offering a holistic approach. This method could lead to more sustainable long-term health benefits without relying on medications, which often come with side effects.

What evidence suggests that this lifestyle intervention is effective for night shift health issues?

Research has shown that lifestyle changes can help shift workers stay healthier. Studies have found that planning when to eat and rest can lower the risk of health issues. For people working night shifts, these changes can improve weight and blood sugar levels. In this trial, participants will be divided into two groups: one will receive an immediate lifestyle intervention focusing on food and rest, while the other will receive the intervention after an initial observation period. This structured eating and resting schedule may help manage health challenges caused by night shifts. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew D Frugé, PhD

Principal Investigator

Auburn University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6716979/

Group-based healthy lifestyle workplace interventions for shift ... Current evidence demonstrates that group-based workplace interventions can be effective for supporting shift workers to lose weight and increase physical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6836085/

Dietary Interventions for Night Shift Workers: A Literature Review (1) Background: Night shift workers have greater risks of developing cardiometabolic diseases compared to day workers due to poor sleep quality ...

3. mdpi.com mdpi.com/2072-6643/17/21/3342

A Randomized Controlled Crossover Lifestyle Intervention ... This study aimed to determine whether a practical lifestyle intervention emphasizing nutrition timing and recovery habits could mitigate the metabolic and ...

4. nature.com nature.com/articles/s41598-025-11534-5

A qualitative study on nutrition and well-being of healthcare ... This study highlighted significant challenges faced by healthcare shift workers in maintaining optimal dietary and other lifestyle behaviours, ...

5. researchgate.net researchgate.net/publication/396868786_A_Randomized_Controlled_Crossover_Lifestyle_Intervention_to_Improve_Metabolic_and_Mental_Health_in_Female_Healthcare_Night-Shift_Workers

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

6. mdpi.com mdpi.com/2072-6643/17/21/3342/review_report

A Randomized Controlled Crossover Lifestyle Intervention ... In the present work, the authors propose that lifestyle interventions for night shift workers improved dietary protein intake, though they did not improve serum ...