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Behavioral Intervention

Lifestyle Intervention for Night Shift Health Issues

N/A
Waitlist Available
Led By Andrew D Frugé, PhD
Research Sponsored by Auburn University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-50 years
Female
Must not have
Pregnant or undergoing hormonal treatment for fertility
Major surgeries in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 0-8 weeks; 8-16 weeks
Awards & highlights

Summary

This trial will study how diet, sleep, and physical activity affect the health of night shift workers, with the goal of improving quality and quantity of life.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since it's a lifestyle intervention focusing on nutrition and sleep/rest timing rather than medication, side effects are minimal but may include initial fatigue or stress from adapting to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant or receiving hormonal fertility treatments.
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I have not had any major surgeries in the last 3 months.
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I have been diagnosed with Type 2 Diabetes or another major endocrine disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 0-8 weeks; 8-16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 0-8 weeks; 8-16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mental Quality of Life
Physical Quality of Life
Visceral fat percentage
Secondary study objectives
Fasting alanine aminotransferase (ALT)
Fasting serum blood glucose
Fasting serum low-density lipoproteins (LDL)
+5 more

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411
35%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate interventionExperimental Treatment1 Intervention
Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only
Group II: Delayed interventionActive Control1 Intervention
Participants will receive the 8-week intervention after 8 weeks of observation-only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 3
~8370

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor
78 Previous Clinical Trials
14,572 Total Patients Enrolled
1 Trials studying Insomnia
64 Patients Enrolled for Insomnia
Andrew D Frugé, PhDPrincipal InvestigatorAuburn University
2 Previous Clinical Trials
48 Total Patients Enrolled
~8 spots leftby Sep 2025
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