Trials / Completed
CompletedNCT03533023
The Healthy Heroes Study
Optimizing Circadian Rhythms by Regulating Eating Patterns to Reduce Cardiometabolic Disease Risk Among Firefighters--The Healthy Heroes Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2021-03-04
- Completion
- 2021-03-04
- First posted
- 2018-05-22
- Last updated
- 2021-08-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03533023. Inclusion in this directory is not an endorsement.