Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
SHIFT
2 other identifiers
interventional
180
1 country
1
Brief Summary
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. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 3, 2029
December 17, 2025
December 1, 2025
3.2 years
March 12, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Body Fat Mass (kg)
Total Body Fat Mass (kg) assessed by DXA
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Secondary Outcomes (13)
Body weight (kg) in clinic
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Body Mass Index
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
HbA1c (%)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Intra-Daily Glycemic Variability: CONGA (A.U.)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Inter-Daily Glycemic Variability: MODD (mg/dL)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
- +8 more secondary outcomes
Other Outcomes (21)
Lean Mass (g)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Percent Body Fat (%)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
Visceral Adipose Tissue Mass (g)
Baseline, 3 month, 6 month (primary), and 12 month (follow-up)
- +18 more other outcomes
Study Arms (3)
Dietary Monitoring
ACTIVE COMPARATORLog all dietary intake and continue habitual eating patterns.
Time-Restricted Eating (TRE)
EXPERIMENTALDietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window
Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS)
EXPERIMENTALDietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts.
Interventions
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns.
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window.
Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team.
Eligibility Criteria
You may qualify 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.
- 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 allowed
- 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.
You may not qualify 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 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego Altman Clinical and Translational Research Institute
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Manoogian, Ph.D.
Salk Institute for Biological Studies
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Scientist
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 24, 2025
Study Start
June 2, 2025
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
March 3, 2029
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available within 1 month of publication with no set end date (minimum of 5 years).
- Access Criteria
- Data will be available to anyone who wants to access it through a data depository that will be disclosed at the time of publication.
We will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).