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| Funder | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES |
|---|---|
| Recipient Organization | Salk Institute for Biological Studies |
| Country | United States |
| Start Date | Aug 01, 2024 |
| End Date | May 31, 2029 |
| Duration | 1,764 days |
| Number of Grantees | 1 |
| Roles | Principal Investigator |
| Data Source | NIH (US) |
| Grant ID | 10860172 |
Project Summary. Greater than 20% of the active US workforce are shift workers who, because of their work schedules, have disrupted eating patterns, sleep/wake cycles, and light exposure, resulting in circadian rhythm disruption. Unfortunately, the only aspect that can be modified is the timing of dietary intake. Shift work-related
late night and erratic eating patterns increase the risk of obesity and cardiometabolic diseases, and accelerate disease progression and emergence of complications. Even a few years of shift work results in detrimental effects on overall cardiometabolic health that persist long after the shift work ceases. Hence, shift workers bear a
disproportionately heavy burden in terms of obesity and cardiometabolic disorders. Exacerbating this problem is the fact that the vast majority (>99.98%) of studies examining behavioral and pharmacological interventions actively exclude shift workers. Major challenges to incorporating shift workers into clinical research are their
variable schedules and daytime sleeping habits, making frequent in-person study visits or group-based interventions (such as diet and nutrition classes) impractical. To overcome this significant barrier to caring for shift workers, an effective intervention should address and improve eating patterns through lifestyle interventions
that are pragmatic for real-world applications that can be applied remotely. This can be achieved by using contemporary methods for effective patient education, engagement, monitoring, retention, and the promotion of intervention adherence. The proposed clinical study makes innovative use of digital and mobile technologies to
study the effect of time-restricted eating (TRE) and TRE with a low-glycemic snack (TRE-LGS) during night shifts as dietary interventions to improve the health of shift workers, specifically nurses and nursing assistants working night shifts. TRE is a behavioral eating pattern intervention that combines the in-depth scientific knowledge of
the beneficial effects of fasting with the impact of meal timing on biological rhythms. A well-validated smartphone app, myCircadianClock, has been used to monitor and facilitate a TRE eating pattern intervention in prior published clinical trials and will be used in this study. Wearable sensors will be used for longitudinal and periodic
measurements of activity and sleep patterns, interstitial blood glucose, blood pressure, and body weight. A combination of live video consultation and digital educational materials will be used to guide participants through the intervention. The proposed study will recruit overweight and obese adult night shift workers who will be
randomized into one of three arms: 1) standard of care (SOC) who will be advised to follow a Mediterranean Diet, 2) SOC + a personalized 10 hours of TRE intervention, of 3) TRE with a provided low glycemic snack during night shifts. All participants will undergo 6-months of guided intervention and 6 months of self-guided intervention.
All groups will be exposed to the same digital platform for the delivery and monitoring of intervention. It is hypothesized that TRE and TRE+LGS will be effective and viable approaches to promote weight loss and improve metabolic health in shift workers.
Salk Institute for Biological Studies
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