Clinical trial NCT03533023: The Healthy Heroes Study
Official title: Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Salk Institute for Biological Studies
First posted: 2018-05-22
Enrollment: 153
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluate the impact of TRE on glucose homeostasis 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
measure: Assess the feasibility and adherence of TRE
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Secondary outcomes:
measure: Assess changes in metabolic biomarkers in response to TRE at end of intervention compared to baseline
timeFrame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Systolic blood pressure (mmHg) in response to TRE at end of intervention compared to baseline
timeFrame: Timeframe: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Diastolic 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
measure: Body weight (kg)
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Other outcomes:
measure: Body mass index (kg/m^2)
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Waist and hip circumference (cm)
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Hip (cm)/waist (cm) ratio
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Body composition including but not limited to fat percentage (%), fat mass (kg), and lean mass (kg)
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
measure: Questionnaires (quality of life, sleep, and health)
timeFrame: primary endpoint=12-week intervention (compared to 2-week baseline); follow-up will be at 1-year
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Pam Taub, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.