Assessing the Impact of Rotational and Shift Work on Sleep, Activity, Energy Balance, and Food Choice in Adults (SWEAT)

December 7, 2022 updated by: Scott Harding, Memorial University of Newfoundland

The goal of this observational study is to compare different work schedules in adults above 30 years of age. Shift and rotational work have become increasingly common owing to the demand for 24/7 availability, especially in the province of Newfoundland, where a large cohort of workers are involved in shift working hours. There is an emerging body of evidence linking shift work with adverse health outcomes, including cardiovascular diseases, type 2 diabetes, cancer, and obesity. Short and poor-quality sleep usually results from repeated exposure to shift work, leading to disturbed circadian rhythms and energy balances. The main question this study aims to answer is the effect of shift and rotational work on physical activity, sleep and food choices in adults. Participants are required to do the following:

  1. Wearing an actigraphy watch, which is very similar to any other wristwatch, for seven days to objectively record their physical activity and sleep.
  2. Participants will be asked to do two 24-hour food recalls using Automated Self-Administered 24-hour (ASA24), a free dietary assessment web-based tool.
  3. Fill out a few questionnaires regarding demographics, chronotype (evening or morning preference), work schedule, sleep quality, stress levels, and physical activity levels.

This is a field-based observational study collecting data both objectively and subjectively. The target population comprises 15 shift workers, 15 rotational workers and 15 daytime workers. This study will involve two visits to the lab. At the baseline, after taking informed written consent, anthropometric measurements, which include height, weight, and blood pressure, will be taken. Along with that, demographic, work schedule, and chronotype questionnaires will be filled. Participants will be instructed how to use the Actigraphy watch, ASA24, and sleep diary at home. After 7 days, participants will be asked to return to the lab to return the material. Participants will be asked to complete the physical activity, sleep quality and stress questionnaires. This study aims to monitor free-living behaviours in actual shift workers while participants are engaged in real-life work shifts.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Despite the rising evidence of harmful health effects from sleep disruption caused by shift employment, society relies on it. Shift work is a broad word that refers to any work schedule that is not between the hours of 8 a.m. and 4 p.m. This study considers three groups: 1) day workers - Including people working from 9 a.m. to 5 p.m./8 a.m. to 4 p.m. 2) shift workers - Including those involved in any arrangement of daily working hours other than the standard daylight hours 8 a.m. - 5 p.m 3) rotational workers - Including those who work on set schedule and working hours are rotating on a set schedule. This study will not include offshore workers. According to the International Agency for Research on Cancer (IARC), night shift work has been classified as Group 2A, probably carcinogenic to humans, based on sufficient evidence of cancer in animals and limited evidence in humans. Shift work affects humans in many ways, mainly by disturbing the body's circadian rhythm and sleep patterns. During the night, human bodies produce melatonin and maintains a constant stream of melatonin signals that leads to sound sleeping. However, working at night puts shift workers in a circadian misalignment due to melatonin suppression. With a disturbed circadian rhythm, the different systems in the body don't function optimally. A person can struggle to fall asleep, wake up during the night, or be unable to sleep as long as they want in the morning. Another significant side effect of shift work is altered meal timing and disturbed hormonal balance. The key regulators of satiety and hunger, the hormones Leptin and Ghrelin, respectively, are driven by body's biological clock. Ghrelin stimulates appetite and decreases after meals with a reverse diurnal pattern from Leptin. Usually, these hormones work in concert to regulate feeding with meal size and time. Previous laboratory studies examining the immediate effects of circadian misalignment have demonstrated decreased Leptin levels and post-meal suppression of Ghrelin. If these results are applied to general shift workers, this may promote weight gain because of an enhanced appetite for calorie-dense foods with eating at night. Therefore, night shift workers tend to have a higher body mass index (BMI) and waist-to-hip ratio than day shift workers. Multiple epidemiological studies controlling potential confounders suggest that exposure to shift work alone can contribute to increased body weight, BMI and a higher prevalence of obesity. A long-term consequence of shift work is an increased risk of type 2 diabetes. As a result of physiological maladaptation to eating at abnormal circadian times, metabolic syndrome develops over time. Both night and rotating shifts have been associated with an elevated risk of heart disease and ischemic stroke. However, shift work and circadian irregularities do not appear to be the only factors contributing to adverse heart health outcomes but also the psychological and psychosocial stress associated with shift work.

This study's primary objective is to compare the diet patterns of day workers, shift workers and rotational workers. Previous research has shown no significant differences in the daily caloric intake of shift workers against day workers. Night workers have an enhanced preference for high-fat foods. However, in most of these studies, food intake was measured subjectively using Food Frequency Questionnaires (FFQ) and self-reported food diaries. Subjective tools may lead to inaccurate conclusions. Objective measurement of food intake in shift workers in real-life situations is required instead of a laboratory-based shift work simulation study. The international recommendation for acceptable daily macronutrient distribution for carbohydrates is 45-65%; for fats and protein, figures are 20-35% and 10-35%, respectively. This study is interested in analyzing the adherence to the daily macronutrient distribution by shift, rotational and day workers and if shift workers can achieve the recommendation for a healthy diet. The hypothesis is that shift and rotational workers would have a reduced score for vegetable, fruit and fibre intake. This research aims to study the timings and duration of food intake in workers. These factors can potentially explain the high obesity rate in shift workers and the increased risk for chronic noncommunicable diseases. Another objective is to inter compare the food intake of every worker on a working day and on a non-working day. This study is interested in seeing the caloric intake difference between the rest days and work days, frequency of eating moments, energy distribution of meals, timing of eating, and fasting intervals of workers from different categories. Considering how all these factors impact metabolic parameters like glucose tolerance and energy metabolism, evaluating these specific dietary measures is crucial.

Stress is another major factor that can influence workers' eating patterns, while only a few studies have been done to assess the impact of stress on the eating habits of shift workers. A nurse's study showed that stress significantly predicts energy and saturated fat intake. Often shift workers use food as a coping strategy for dealing with negative mood states. The objective is to compare stress levels between different worker categories and relate them to eating habits respectively.

This is a feasibility study which means data collected from this study will help determine the sample size and other factors for a large-scale intervention trial in the working cohort of Newfoundland. No previous study has been done on Newfoundland workers. This study aims to inform the design and implementation of a fully-funded trial. Data collected from this study will be used for developing hypotheses and sample sizes for future studies.

Secondary objective is to compare sleep levels in different cohorts of workers. Sleep quality is very subjective, implying that it can have different meanings for different persons. To compare sleep quality in terms of sleep duration, sleep efficiency, sleep onset time, total elapsed bedtime, and total sleep time in day workers, shift workers, and rotational workers.

To measure if shift and rotational work have any impact on the physical activity of workers. To compare the physical activity levels of different workers in terms of light/sedentary, moderate and vigorous physical activity.

It also includes collecting data to know each participant's chronotype preference. To compare this with each participant's work schedule and see if chronotype-aligned work schedules are more beneficial. Measuring objectively and subjectively each participant's physical activity and sleep quality. SWEAT study is interested in comparing both parameters' similarity and variability in the subjective and objective data. Determining the relationship between shift and rotational work and the cardiometabolic disease risk factors through the parameters we are measuring.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3X5
        • Recruiting
        • Nutrition and Lifestyle Lab, Department of Earth Sciences, Memorial University of Newfoundland, 9 Arctic Ave
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target study population will be recruited by advertising study directly and indirectly. We will contact local employment unions in Newfoundland to advertise our study and ask for participation, making social media accounts for the SWEAT study and advertising the study on Facebook, Instagram and Twitter. Standard passive approaches will be used, including study advertisement posters on community bulletin boards; poster distribution in public places like shopping malls, hospitals, long-term care homes, worker unions, and police departments; promotion on community radio stations, and promotion via the Memorial University Newsline.

Description

Inclusion Criteria:

  1. 30 years of age or older.
  2. Should be able to wear a watch for seven days.
  3. Should be working.

Exclusion Criteria:

  1. Shifts less than 4.5 hours or shifts longer than 14 hours will not be considered.
  2. Being pregnant.
  3. Currently being breastfeeding.
  4. Having a child less than 1 year old at home.
  5. Travelled across time zones in the last four weeks.
  6. No change in medication in the last six months for any previous ongoing medical condition (by self-reported health history).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Day workers
Includes people working from 9 a.m. to 5 p.m./8 a.m. to 4 p.m. We will be recruiting 15 day workers.
Participants are categorized by the type of work hours they must maintain. For example, regular work hours, shift work, and rotational work.
Shift workers
Includes those involved in any arrangement of daily working hours other than the standard daylight hours, 8 a.m. - 5 p.m. It also includes on-call or casual workers. We will be recruiting 15 shift workers.
Participants are categorized by the type of work hours they must maintain. For example, regular work hours, shift work, and rotational work.
Rotational workers
Includes those who work on a set schedule and whose working hours are rotating on a set schedule. We do not include offshore workers here. We will be recruiting 15 rotational workers.
Participants are categorized by the type of work hours they must maintain. For example, regular work hours, shift work, and rotational work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Intake
Time Frame: Two 24-hour recalls on any day of the 7-days tracking period. Participants will be asked to complete one on working day other on non-working day, but this is not mandatory.
Two online 24-hour food recalls using Automated Self-Administered Dietary Assessment Tool(ASA24). ASA24 is a free web-based application that allows for numerous automatically coded self-administered 24-hour recalls and dietary records for epidemiologic, interventional, behavioural, or clinical research.
Two 24-hour recalls on any day of the 7-days tracking period. Participants will be asked to complete one on working day other on non-working day, but this is not mandatory.
Stress levels
Time Frame: On the second visit which is after 7 days from the first visit to the lab.
Participants will be asked to fill the Perceived Stress Scale (PSS). It is a stress assessment instrument. It gives scores between 0-40. Higher scores means high level of stress.
On the second visit which is after 7 days from the first visit to the lab.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Measurement
Time Frame: Participant will be given Actigraphy watch on their first visit and will be asked to wear it for the next seven days continuously without removing. During the second visit which is after seven days, the watch will be removed by study staff.
Sleep parameters including: total sleep time, bedtime, rise-time, sleep quality and efficiency, wake after sleep onset, sleep interruptions, posture changes using GENEActiv(Actigraphy) watch. Actigraphy is method of measuring human movement, activities and behaviours. It is normally worn on the wrist and measures temperature and environmental light as well. We are using the model GENEActiv by Activinsights Ltd, Cambs, UK.
Participant will be given Actigraphy watch on their first visit and will be asked to wear it for the next seven days continuously without removing. During the second visit which is after seven days, the watch will be removed by study staff.
Sleep Quality
Time Frame: On the second visit which is after 7 days from the first visit to the lab.
Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI). It is self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It gives score between 0 and 21. Any score more than 5 is associated with poor sleep quality.
On the second visit which is after 7 days from the first visit to the lab.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Scott Harding, Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Estimate)

December 15, 2022

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2022.134
  • 20230493 (Other Identifier: Memorial University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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