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The Healthy Heroes Study

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ClinicalTrials.gov Identifier: NCT03533023
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Salk Institute for Biological Studies
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Shift Workers' Health Time Restricted Eating Fasting Behavioral: Time Restricted Eating + Standard of Care Behavioral: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: TRE + SOC
Time Restricted Eating + Standard of Care
Behavioral: 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.
Other Name: Time Restricted Eating

SOC
Standard of Care
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.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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 ]

    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.


  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Body weight (kg) [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    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.


Other Outcome Measures:
  1. Body mass index (kg/m^2) [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    Calculated from body weight (kg) and height (m). Note: Significant changes expected in participants who had elevated BMI at baseline. No significant changes expected in those whose BMI was not elevated at baseline.

  2. Waist and hip circumference (cm) [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    Measured with standardized body tape measure. Note: Significant changes expected in participants who had increased waist and hip circumference at baseline. No significant changes expected in those without increased waist and hip circumference at baseline.

  3. Hip (cm)/waist (cm) ratio [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    Measured using tape measure. Note: Significant changes expected in participants who had an increased hip/waist ratio at baseline. No significant changes expected in those without increases at baseline

  4. Body composition including but not limited to fat percentage (%), fat mass (kg), and lean mass (kg) [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    Measured by Tanita Digital Scale. Note: Significant changes expected in participants who had elevations levels at baseline. No significant changes expected in those without elevations at baseline.

  5. Questionnaires (quality of life, sleep, and health) [ Time Frame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year ]
    Measured by SF-36, PSQI, and ESS. Note: Significant changes expected in participants who had decreased self-reporting of the above-mentioned questionnaires at baseline. No significant changes expected in those without decreases at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

As per recommendations from the fire department, fire department unions, and funding agencies, we did not require compromised health measures (e.g. hyperglycemia, hypertension, etc.) as inclusion criteria for they would be discriminatory against some firefighters.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533023


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Salk Institute for Biological Studies
Investigators
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Principal Investigator: Pam Taub, MD UCSD
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Responsible Party: Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03533023    
Other Study ID Numbers: 172083
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pam Taub, MD, University of California, San Diego:
Firefighters
San Diego Fire and Rescue
Cardiometabolic Health
First Responder
Shift Workers
Time-Restricted Eating
Fasting