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| Name | Class |
|---|---|
| South Eastern Sydney Local Health District | OTHER_GOV |
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The aim of this clinical trial is to assess whether it is feasible for shift workers to follow a time-restricted eating diet. The trial will investigate the impact of time-restricted eating on blood glucose levels during day and night shifts both with and without the time-restricted eating diet.
The trial aims are:
Shift work is an essential component of modern workforces, with about 20% of the workforce regularly engaged in shift work. Research has shown shift workers are at higher risk of chronic diseases, including cardiometabolic disease, compared to day-only workers. Specifically, evidence shows eating overnight significantly increases the risk of metabolic syndrome. We also know eating patterns of shift workers and non-shift workers are different with evidence from our research showing shift workers engaged in night shift change their eating behaviors compared to day shifts. With a substantial proportion of the workforce involved in shift work, understanding the health challenges is crucial for developing targeted interventions and promoting a healthier shift working population.
Despite the need for behavioural eating interventions in shift workers, there is a lack of studies examining how these eating interventions would be implemented in real world contexts. Some dietary interventions related to quantity, quality and timing of food in shift workers have been reported, including limiting the quantity of food with various macronutrient restriction and low-calorie meal replacements, improving the quality of food with dietary advice/counselling, and promoting healthier food choices with variable results.
With recent recognition of the timing of food consumption being an important factor of metabolic regulation, time restricted eating (TRE) offers a viable strategy for improving metabolic health. TRE is a chrono-nutritional strategy involving close alignment of meal timing with typical circadian physiology over 24-hour periods. Typically, this involves an eating window of approximately 8 hours, with no eating during the night. Evidence shows TRE improves alignment of the fasting/eating cycle with the central circadian pacemaker and initiating nutrient-sensing pathways to ensure nutrient homeostasis. Research has shown TRE is an effective chrono-nutritional intervention for weight reduction, improvements in HbA1c and insulin levels, reduced insulin resistance or enhanced insulin sensitivity, improved glucose tolerance and reduced mean fasting glucose and improved quality of life. However, using TRE has not been examined extensively in shift workers in real world settings.
A recent narrative review found only three studies had investigated TRE as a diet strategy for shift workers under real-life conditions and these studies were conducted in populations with limited exposure to shift work situations (e.g. rotating shift work). Therefore, research is required that investigates the feasibility of TRE during night shifts in rotating shift workers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Eating | Experimental | Participants will follow a time-restricted eating diet during day and night shifts over 2 weeks |
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| Control Arm | No Intervention | Participants will follow their usual eating patterns without restrictions during day and night shifts over 2 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating | Behavioral | The intervention arm will consist of a time-restricted eating protocol with fasting between 11:00 PM to 6:00 AM. Ad libitum eating will be allowed outside these times and the protocol will be administered during day and night shifts over a 2 week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of time-restricted eating (TRE) among shift workers (Recruitment and Participation Rate) | Feasibility will be assessed through a composite of the following metrics: Recruitment and participation rate (%) will be assessed as the percentage of participants randomized from the screened population. Each component will be assessed separately but reported as contributing factors to the overall feasibility. | From enrolment to end of treatment at 2 weeks |
| Feasibility of time-restricted eating (TRE) among shift workers (Adherence Rate) | Feasibility will be assessed through a composite of the following metrics: Adherence rate (%) percentage of participants who comply with the TRE protocol over a 2-week period, determined using self-reports Each component will be assessed separately but reported as contributing factors to the overall feasibility. | Two weeks |
| Feasibility of time-restricted eating (TRE) among shift workers (Study Completion Rate) | Feasibility will be assessed through a composite of the following metrics: Study completion rate (%) percentage of participants who complete the 2-week study period without dropping out. Each component will be assessed separately but reported as contributing factors to the overall feasibility. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose levels during the 2-week study period |
| 2 weeks |
| Facilitators and barriers associated with adherence to time restricted eating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Gordon, PhD | Woolcock Institute of Medical Research and Macquarie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sutherland Hospital | Caringbah | New South Wales | 2229 | Australia |
All data will be dei-dentified using a unique study ID.
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D005215 | Fasting |
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Open label trial assessing a behavioral eating intervention
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Only in the intervention arm, participants will be asked questions about issues about eating patterns during the time restricted eating including barriers and facilitators for maintaining the fasting period. |
| 2 weeks |