RECRUITING

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers

Conditions

Night Shift Work Time Restricted Eating Overweight Obesity Time-Restricted Eating Nurses Nursing Assistants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - the SHIFT Study

Quick Facts

Study Start:2025-04

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06891352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age: 18-70 years * BMI ≥ 25 kg/m2 * 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.	* 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 \> 42 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, stroke/transient ischemic attack) * 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 * Any history of surgical intervention for weight management * Uncontrolled psychiatric disorder including prior hospitalization

Inclusion Criteria

Exclusion Criteria

* Age: 18-70 years
* BMI ≥ 25 kg/m2
* 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.

* 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 \> 42 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, stroke/transient ischemic attack)
* 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
* Any history of surgical intervention for weight management
* Uncontrolled psychiatric disorder including prior hospitalization

Contacts and Locations

Study Contact

UCSD Study Coordinator

CONTACT

858-246-2342

research@mycircadianclock.org

Salk Clinical Researcher

CONTACT

858-453-4100

research@mycircadianclock.org

Principal Investigator

Emily Manoogian, Ph.D.

PRINCIPAL_INVESTIGATOR

Salk Institute for Biological Studies

Study Locations (Sites)

University of California San Diego Altman Clinical and Translational Research Institute

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: Salk Institute for Biological Studies

Emily Manoogian, Ph.D., PRINCIPAL_INVESTIGATOR, Salk Institute for Biological Studies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2029-03

Study Record Updates

Study Start Date2025-04

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

Time-Restricted Eating
Night Shift work
Nurses
Nursing Assistants

Additional Relevant MeSH Terms

Night Shift Work
Time Restricted Eating
Overweight
Obesity