The Healthy Heroes Study



Status:Recruiting
Healthy:No
Age Range:21 - 65
Updated:10/26/2018
Start Date:May 8, 2018
End Date:May 2021
Contact:Hannah Lo, BS
Email:ucsdresearchcoordinator@gmail.com
Phone:858-246-2510

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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 Feeding in emergency responders who work a 24-hour shift schedule.

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 (TRF). 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 TRF 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 glucose monitor,
a wrist-worn actigraphy device, and questionnaires will also be used during the study.

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
We found this trial at
1
site
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Pam Taub, MD
Phone: 858-246-2510
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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