The Healthy Heroes Study

NCT ID: NCT03533023

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2021-03-04

Brief 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. 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.

Conditions

Shift Workers' Health; Time Restricted Eating; Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TRE + SOC

Time Restricted Eating + Standard of Care

Group Type: EXPERIMENTAL

Time Restricted Eating + Standard of Care

Intervention Type: BEHAVIORAL

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.

SOC

Standard of Care

Group Type: OTHER

Standard of Care

Intervention Type: BEHAVIORAL

Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.

Interventions

Time Restricted Eating + Standard of Care

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.

Intervention Type: BEHAVIORAL

Standard of Care

Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.

Intervention Type: BEHAVIORAL

Other Intervention Names

Time Restricted Eating

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salk Institute for Biological Studies

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Pam Taub, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pam Taub, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36198291 (View on PubMed)

Manoogian 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.

Reference Type: DERIVED

PMID: 34135038 (View on PubMed)

Other Identifiers

172083

Identifier Type: -

Identifier Source: org_study_id