Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALTime Restricted Eating + Standard of CareParticipants 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.
BEHAVIORALStandard of CareParticipants 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.

The Healthy Heroes Study (NCT03533023) · Clinical Trials Directory