Shift Workers' HealthNCT03533023
The Healthy Heroes Study
A study of Shift Workers' Health and Time Restricted Eating, run by University of California, San Diego at 1 site in United States.
Trial summary
This is the first study of its kind to assess and test an intervention to improve biological rhythms and general health of shift workers, specifically first responders with San Diego Fire and Rescue. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift Workers' Health, Time Restricted Eating, Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Firefighter or work a 24-hr shift schedule with San Diego Fire and Rescue
- Age: 21-65 years
- Own a smartphone (Apple or Android Operating System)
- If participants are on cardiovascular medications (HMG-CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period
Who cannot join
- Insulin-dependent diabetes mellitus
- Presence of acute chronic inflammatory or autoimmune disease (defined by acute symptoms or C-reactive protein >10 mg/L), malabsorption syndromes, liver disease, or kidney disease (stage 3 or greater)
- Uncontrolled thyroid disease
- Intake of drugs likely to interfere with study endpoints, including corticosteroids, anabolic steroids, anti-psychotics, antiretroviral drugs, and immunosuppressive drugs (within 3 months of starting the study)
- Presence or recent history of anemia (hematocrit <33% within 3 months of starting the study)
- History of bariatric surgery
Show all 13Show fewer
- Pregnant or breast-feeding women
- Current or recent (within 12 months of starting the study) pregnancy or breastfeeding, or intention of becoming pregnant in the next 6 months
- Any cancer other than non-melanoma skin cancer in the last 3 years
- On a special or prescribed diet for other reasons (e.g. Celiac disease)
- Depression determined by the Beck Depression Inventory (BDI)
- Planned international travel during study period
- Insufficient logging on the mCC app (does not log at least 2 entries a day for 10 of 14 days) during baseline will exclude from being randomized into the intervention period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
This is the first study of its kind to assess and test an intervention to improve biological rhythms and general health of shift workers, specifically first responders with San Diego Fire and Rescue. In a randomized control trial, investigators intend to measure the health impact of Time Restricted Eating in emergency responders who work a 24-hour shift schedule.
Read the detailed description
Participants will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of standard of care with the addition of adopting a 10 hour eating window for one year (TRE). For the first 3 months of intervention, participants will be monitored closely by the research team. For the following 9 months, participants will be in a self-monitored intervention period. Investigators will evaluate the impact of TRE on blood glucose levels, biomarkers, sleep/mood, and weight loss. These assessments will be made at baseline, at the end of the 12-week monitored intervention period, and every 3 months (months 6, 9, and 12) during the self-monitored intervention period for one year. Food/drink intake, activity, and sleep will be monitored with the smartphone myCircadianClock application ("mCC app") throughout the study. A continuous glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during the study.
- Conditions
- Shift Workers' Health, Time Restricted Eating, Fasting
- Being tested
- Time Restricted Eating + Standard of Care, Standard of Care
- Keywords
- Firefighters, San Diego Fire and Rescue, Cardiometabolic Health, First Responder, Shift Workers, Time-Restricted Eating, Fasting
- Medical subject headings
- Intermittent Fasting, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted Eating + Standard of CareBehavioural
Also called Time Restricted Eating
Participants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietician.
Standard of CareBehavioural
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
| Study group | Role | What they receive |
|---|---|---|
| TRE + SOC | Experimental | Time Restricted Eating + Standard of Care Receives: Behavioral: Time Restricted Eating + Standard of Care |
| SOC | Other | Standard of Care Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of TRE on glucose homeostasis at end of intervention compared to baseline
Measured by an ambulatory continuous glucose monitoring device and blood work throughout the study.
Note: Significant changes expected in participants who had elevated glucose homeostasis at baseline. No significant changes expected in those within normal ranges at baseline. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Measured: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Assess the feasibility and adherence of TRE
Measured by percentage of days logged that participants ate within their 10-hour window and by end of study responses.
Note: Significant changes expected in participants in the TRE arm of the study on and off shift. No significant changes expected in the standard of care arm of the study. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Measured: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Secondary outcomes (4)
Assess changes in metabolic biomarkers in response to TRE at end of intervention compared to baseline
Measured with blood biochemistry.Measured with blood biochemistry under TRE, including, but not limited to: fasting glucose, HbA1c, cholesterol, and triglycerides.
Note: Significant changes expected in participants who had abnormal levels at baseline (e.g. elevated LDL cholesterol, low HDL cholesterol, elevated triglycerides). No significant changes expected in those were within normal ranges at baseline.
Measured: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Systolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Measured at baseline and during TRE intervention. Note: Significant changes expected in participants who had elevated systolic blood pressure at baseline. No significant changes expected in those without elevated systolic blood pressure at baseline.
Measured: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Diastolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Measured at baseline and during TRE intervention. Note: Significant changes expected in participants who had elevated diastolic blood pressure at baseline. No significant changes expected in those without elevated diastolic blood pressure at baseline.
Measured: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Body weight (kg)
Measured on a digital scale. Note: Significant changes expected in participants who had elevated weight at baseline. No significant changes expected in those who were not overweight at baseline.
Measured: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start8 May 2018
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shift Workers' HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533023
- Sponsor's protocol ID
- 172083
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manoogian ENC, Zadourian A, Lo HC, Gutierrez NR, Shoghi A, Rosander A, Pazargadi A, Ormiston CK, Wang X, Sui J, Hou Z, Fleischer JG, Golshan S, Taub PR, Panda S. Feasibility of time-restricted eating and impacts on cardiometabolic health in 24-h shift workers: The Healthy Heroes randomized control trial. Cell Metab. 2022 Oct 4;34(10):1442-1456.e7. doi: 10.1016/j.cmet.2022.08.018.
PubMed 36198291Manoogian ENC, Zadourian A, Lo HC, Gutierrez NR, Shoghi A, Rosander A, Pazargadi A, Wang X, Fleischer JG, Golshan S, Taub PR, Panda S. Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study. BMJ Open. 2021 Jun 16;11(6):e045537. doi: 10.1136/bmjopen-2020-045537.
PubMed 34135038
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
- ClinicalTrials.gov ID
- NCT03533023
- Acronym / sponsor ID
- 172083
- Conditions
- Shift Workers' Health, Time Restricted Eating, Fasting
- Keywords
- Firefighters, San Diego Fire and Rescue, Cardiometabolic Health, First Responder, Shift Workers, Time-Restricted Eating, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Study start
- 8 May 2018 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first study of its kind to assess and test an intervention to improve biological rhythms and general health of shift workers, specifically first responders with San Diego Fire and Rescue. In a randomized control trial, investigators intend to measure the health impact of Time Restricted Eating in emergency responders who work a 24-hour shift schedule.
Detailed description
Participants will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of standard of care with the addition of adopting a 10 hour eating window for one year (TRE). For the first 3 months of intervention, participants will be monitored closely by the research team. For the following 9 months, participants will be in a self-monitored intervention period. Investigators will evaluate the impact of TRE on blood glucose levels, biomarkers, sleep/mood, and weight loss. These assessments will be made at baseline, at the end of the 12-week monitored intervention period, and every 3 months (months 6, 9, and 12) during the self-monitored intervention period for one year. Food/drink intake, activity, and sleep will be monitored with the smartphone myCircadianClock application ("mCC app") throughout the study. A continuous glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRE + SOC | Experimental | Behavioral: Time Restricted Eating + Standard of CareTime Restricted Eating + Standard of Care |
| SOC | Other | Behavioral: Standard of CareStandard of Care |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Firefighter or work a 24-hr shift schedule with San Diego Fire and Rescue
- Age: 21-65 years
- Own a smartphone (Apple or Android Operating System)
- If participants are on cardiovascular medications (HMG-CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period
Key exclusion criteria (13 listed)
- Insulin-dependent diabetes mellitus
- Presence of acute chronic inflammatory or autoimmune disease (defined by acute symptoms or C-reactive protein >10 mg/L), malabsorption syndromes, liver disease, or kidney disease (stage 3 or greater)
- Uncontrolled thyroid disease
- Intake of drugs likely to interfere with study endpoints, including corticosteroids, anabolic steroids, anti-psychotics, antiretroviral drugs, and immunosuppressive drugs (within 3 months of starting the study)
- Presence or recent history of anemia (hematocrit <33% within 3 months of starting the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted Eating + Standard of CareAlso: Time Restricted EatingParticipants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietician. | Behavioural | TRE + SOC |
| Standard of CareParticipants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window. | Behavioural | SOC |
Primary outcome
Evaluate the impact of TRE on glucose homeostasis at end of intervention compared to baseline
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Measured by an ambulatory continuous glucose monitoring device and blood work throughout the study. Note: Significant changes expected in participants who had elevated glucose homeostasis at baseline. No significant changes expected in those within normal ranges at baseline. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
Assess the feasibility and adherence of TRE
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Measured by percentage of days logged that participants ate within their 10-hour window and by end of study responses. Note: Significant changes expected in participants in the TRE arm of the study on and off shift. No significant changes expected in the standard of care arm of the study. Primary endpoint analysis will be done by comparing baseline and 12-week intervention.
4 secondary outcomes
Assess changes in metabolic biomarkers in response to TRE at end of intervention compared to baseline
Time frame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Systolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Time frame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Diastolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Body weight (kg)
Time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 36198291Manoogian ENC, Zadourian A, Lo HC, Gutierrez NR, Shoghi A, Rosander A, Pazargadi A, Ormiston CK, Wang X, Sui J, Hou Z, Fleischer JG, Golshan S, Taub PR, Panda S. Feasibility of time-restricted eating and impacts on cardiometabolic health in 24-h shift workers: The Healthy Heroes randomized control trial. Cell Metab. 2022 Oct 4;34(10):1442-1456.e7. doi: 10.1016/j.cmet.2022.08.018.
- Derived from this study: PubMed 34135038Manoogian ENC, Zadourian A, Lo HC, Gutierrez NR, Shoghi A, Rosander A, Pazargadi A, Wang X, Fleischer JG, Golshan S, Taub PR, Panda S. Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study. BMJ Open. 2021 Jun 16;11(6):e045537. doi: 10.1136/bmjopen-2020-045537.
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Healthy Volunteers (HV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pam Taub, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Shift Workers' Health and Time Restricted Eating, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of TRE on glucose homeostasis at end of intervention compared to baseline (time frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533023, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.