The Healthy Heroes Study

NCT03533023 | Completed

• 1 other identifier: 172083
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year

• Body weight (kg)

  primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year

Other Outcomes (5)

• Body mass index (kg/m^2)

  primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year

• Waist and hip circumference (cm)

  primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year

• Hip (cm)/waist (cm) ratio

  primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year

Study Arms (2)

TRE + SOC

EXPERIMENTAL

Time Restricted Eating + Standard of Care

Behavioral: Time Restricted Eating + Standard of Care

SOC

OTHER

Standard of Care

Behavioral: Standard of Care

Interventions

Time Restricted Eating + Standard of Care 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.

Also known as: Time Restricted Eating

TRE + SOC

Standard of Care 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.

SOC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

• 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.

  PMID: 36198291 DERIVED

• 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.

  PMID: 34135038 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Fasting

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pam Taub, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 22, 2018
• Study Start: May 8, 2018
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

US (1)