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New treatment option for Night Shift Work
Official title Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
ClinicalTrials.gov ID: NCT06891352
What this study is testing
- What it's testing
- In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age: 18-70 years
- BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating window ≥ 14 h/day
- Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
You likely can't join if
- Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at...
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
- BMI \> 50 kg/m2
- Change in medications that could impact study outcomes within the past 3 months
See the full eligibility criteria
- Age: 18-70 years
- BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating window ≥ 14 h/day
- Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
- Have been doing night shift work for at least 3 months.
- Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are...
- If patients have Type 2 Diabetes, they will be included in the study if A1c is less than 9 and they are not on insulin.
- Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
- Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
- Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
- Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
- BMI \> 50 kg/m2
- Change in medications that could impact study outcomes within the past 3 months
- Change in weight of \>4kg in the past 3 months
- Women who are pregnant, breastfeeding, or are trying to become pregnant during the study period. If a participant becomes pregnant during the study, they will be excluded from continuing the study.
- Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
- Fasting LDL cholesterol greater than 250 mg/dL
- Fasting triglycerides greater than 500g/dL
- Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
- Frequent (more than 4) travel involving a time zone change of more than 3 hours over the 1-year study period
- Prolonged leave from work (a continuous month or longer) during the study
- Active treatment for inflammatory and/or rheumatologic disease
- History of a major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure...
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are acceptable)
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (hypothyroidism on a stable dose of thyroid replacement therapy is allowed).
- History of adrenal disease in the past 5 years
- History of malignancy undergoing active treatment, except non-melanoma skin cancer, in the past 5 years
- History of an eating disorder in the past 5 years
- History of cirrhosis in the past 5 years
- History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
- History of HIV/AIDs
- Currently enrolled in weight-loss or weight-management program
- History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
- Uncontrolled psychiatric disorder including prior hospitalization
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.