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Behavioral Intervention

Lifestyle Intervention for Night Shift Health Issues

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 0-8 weeks; 8-16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 50 years old.

Select...

I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 0-8 weeks; 8-16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mental Quality of Life

Physical Quality of Life

Visceral fat percentage

Secondary outcome measures

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

musculoskeletal

vaginal infection

dizziness

hair loss

dental issues

fatigue

flatulence

bladder infection

100%

80%

60%

40%

20%

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 2

~8880

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,379 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the demographic for this research study limited to those aged 35 and younger?

"This clinical trial has a stringent age range for participation, with the minimum being 18 and the maximum 50."

Answered by AI

Are there any additional slots available for participants in this clinical trial?

"Unfortunately, clinicaltrials.gov has indicated that this medical trial is no longer accepting patients. The first posting was on January 15th 2024 and the last edit came on November 28th 2023; however, there are 504 other active studies whose doors remain open to volunteers."

Answered by AI

What are the outlined goals of this investigation?

"This clinical trial, which will be evaluated across an 8 to 16 week period, aims to assess visceral fat percentage. Secondary outcomes include average minutes of daily sleep as defined by accelerometry readings, fasting low-density lipoproteins (LDL) measured via phlebotomy and reported in milligrams per deciliter (mg/dl), with lower concentrations being optimal; as well as the same protocol for triglyceride concentration."

Answered by AI

What criteria are necessary for potential participants of this research endeavor?

"Apt candidates for this clinical trial must be 18-50 years old and suffer from insomnia. This medical experiment is looking to recruit around 24 volunteers in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Metabolic & Mental Health in Female Healthcare Shift Workers

Andrew Fruge 2024. "Improving Metabolic & Mental Health in Female Healthcare Shift Workers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158204.

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