Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-1415732/v1

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Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-1415732/v1

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Background: Shift work is considered a risk factor for a number of chronic health conditions including obesity. Weight reduction in obese patients lowers the risk for cardiovascular disease, diabetes, certain cancers, and mortality. Achieving a negative energy balance by providing low-calorie meal replacements is widely used for weight management. This study aims to evaluate the impact of a low calorie “meal-replacement” on weight and metabolic parameters of shift workers with obesity.

Methods: This trial will be conducted in parallel, randomized controlled design for a period of 8 weeks. A total of 44 shift workers with Body Mass Index over 25 kg/m²will be recruited after assessing eligibility. Participants will be randomly assigned to the test and control groups on a 1:1 ratio. The intervention group (N=22) will be provided with a low calorie (~200 kcal) meal replacement shake as a dinner, and the control group (N=22) will continue their habitual diets. The visits and the evaluations will be done as follows: screening (visit 0), 4 weeks (visit 1), and 8 weeks (visit 2). Anthropometric measurements will be taken at 0, 4 and 8 weeks. Body composition, biochemical parameters, dietary intake and physical activity will be assessed during the first and the last visit.

Outcomes: The primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline. The secondary outcomes will be post intervention changes in the other metabolic parameters.

Discussion: To our knowledge this is one of the first randomized controlled trials evaluating the effects of a meal replacement as the night meal for weight loss in shift worker with obesity. Moreover, improvement of metabolic parameters in shift-workers will be an added benefit to this high risk group.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000231741. Registered on 09 February 2022. https://www.anzctr.org.au/ACTRN12622000231741.aspx

Shift work

obesity

weight loss

meal replacement

low-calorie

The prevalence of shift work is increasing in modern society to cater for the complexity and flexibility of many operations that exceed the duration of a normal work day. Shift work is defined as work performed mostly outside of typical working hours [1]. It has been considered as a major occupational hazard, and there is a plethora of research showing associations between shift work and chronic diseases [2]. Recent studies have shown that shift work was linked to an elevated risk of obesity, particularly abdominal obesity, with the risk being higher among long-term night shift workers [3].

Obesity is a major contributor to and risk factor for increased morbidity and mortality due to a variety of diseases [4]. Global obesity burden has doubled since 1980 and the World Health Organization (WHO) predicts that one out of every five persons will be obese by 2025 [5]. Obesity has increased significantly in all South Asian countries [6]. The prevalence of overweight and obesity has increased by almost 40% from 1990 to 2013 In Southeast Asian region [7]. The level of obesity in Sri Lanka has increased by several folds during the last two decades. According to Sri Lankan body mass index cut-off (BMI ≥ 25 kg/m²), the prevalence of obesity in 2011 was 21.0% and 32.5% in men and women respectively [8]. In 2011, the obesity rates have been increased up to 44.6% in males and 56.3% in females [9].

Unhealthy dietary habits, low physical activity, sleep deprivation, and disruption of the circadian rhythm have been proposed as the potential causes underlying the weight gain among shift workers [10]. The sleep–wake cycle, thermogenesis, food intake, and lipids and glucose metabolism are reported to be influenced by circadian regulation [1]. Short sleep duration has been shown to lower leptin levels while increasing ghrelin levels, leading to an increase in appetite and weight gain [11]. In support of this view, several studies have shown that night shifts are associated with higher energy intake [12].

In addition, altered food habits also have a profound impact on peripheral circadian clock mechanisms [13]. Shift workers were found to consume more inflammatory diets than day workers, especially for dinner which creates a significant metabolic strain for the body (28). Shiftwork, and snacking during evening work in particular, is reported as common, with frequent sugar intake in the form of biscuits, soft drinks and sandwiches that are easy to obtain [14]. Therefore, raising awareness about the effects of shift work on unhealthy food habits, and prescribing evidence-based interventions, may help shift workers' health by preventing weight gain and associated metabolic consequences [15].

A loss of 5–10% of initial body weight is known to be effective in the treatment of many of the complications associated with obesity such as type 2 diabetes, hypertension, and hyperlipidemia [16]. Weight reduction is associated with increased performance and work capacity in obese individuals, thus contributing towards improving their quality of life [17]. Furthermore, following involvement in weight loss interventions, consistent significant increases in psychological indices such as self-esteem, depressive symptoms, body image, and health-related quality of life have been reported. [18]

In comparison to standard energy deficit diets that simply prescribe a reduction in energy intake, evidence shows that meal replacement diets result in greater weight loss [19], better compliance [20] are more likely to provide appropriate intake of essential nutrients and have higher satisfaction and lower drop-out rates [21]. To the best of our knowledge, a dietary intervention with a low calorie meal replacement meal aimed to lose body weight and improve metabolic parameters has not been tested among night shift workers. Therefore, the present randomized controlled trail will be conducted to investigate the effectiveness of a low calorie meal replacement dinner compared to a traditional dinner meal on metabolic parameters of shift workers with obesity.

This protocol was written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (Additional file 1) [22]. The schedule of trial enrollment, interventions and assessments is presented in Table 1.

Table 1

Summarized study schedule at each visit in the clinical trial
	STUDY PERIOD
	Enrolment	Allocation	Post-allocation
TIME POINT	-t₁ (2 weeks)	0	Visit 1 (4 weeks)	Visit 2 (8 weeks)
ENROLMENT
Eligibility screening	×
Informed consent	×
Allocation		×
INTERVENTIONS
Meal replacement group			×	×
No meal replacement group			×	×
ASSESSMENTS
FBG		×		×
Serum HbA1c		×		×
Lipid profile		×		×
Blood pressure		×		×
Anthropometric measures		×	×	×
Body composition measures		×		×
FFQ/ IPAQ		×		×

Objectives and hypothesis

Hypothesis:

Primary- prescribing a reduced caloric meal replacement at dinner will have beneficial effects on weight loss of night shift workers with obesity
Secondary- associated metabolic parameters (lipid profile, glycemic outcomes and blood pressure) will be improved in the treatment group in comparison to the control group

Objectives:

Primary- to investigate if dinner meal replacement with a low calorie meal replacement shake is an effective strategy to achieve a minimum 5% body weight loss in shift workers with obesity compared to conventional dinner.
Secondary- to evaluate the effects on anthropometric parameters, serum lipids, glycemic outcomes and blood pressure.

Study design and setting

This study will be conducted as a parallel, randomized controlled clinical trial at the Nawaloka Hospital PLC, Colombo, Sri Lanka, for a period of 8 weeks, evaluating the effect of a meal replacement for dinner in obese shift workers.

Sample size

A sample of 44 healthcare employees who engage in shift work will be recruited for the study after screening for eligibility against inclusion and exclusion criteria mentioned below. The minimum sample size will be calculated based on the primary outcome, the proportion of participants achieving 5%weight loss after 8 weeks. Previous weight loss intervention trials predicted that 50% of individuals in the intervention group and 10% of participants in the control group would lose at least 5% of their baseline body weight after 8 weeks. [23]. To detect this difference in the proportion of participants achieving 5%weight loss between the intervention and control groups, 17 participants were required in each group, to ensure 80% power at a 5% significance level. To accommodate a 20% dropout rate,we therefore needed to recruit 22 participants in each intervention group. Hence, a total of 44 adults with obesity (BMI > 25kg/m²) will be recruited for the study [24]. The formula used for sample size calculation is presented below;

n_B = Sample size in one arm

P_A = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in placebo group (0.1)

P_B = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in treatment group (0.5)

Κ = Sampling ratio (1:1)

Z_α = Critical value of the normal distribution at α (α is 0.05 and the critical value is 1.96)

Z_β = Critical value of the normal distribution at β (β is 0.2)

Population

The study population will consist of obese health care employees in rotating shift work who provides health care services, either directly (e.g. Doctors and nurses) or indirectly (e.g. helpers, laboratory technicians, medical waste handlers, security officers).

Inclusion and exclusion criteria

Inclusion criteria

Permanent employees aged 18–65 years
Have been working shifts continuously for the past 12 months and continue during the whole study period (8 weeks).
Working at least 3 night shifts/week
Participants with BMI ≥ 25 kg/m²
Not having any allergies to any of the known food ingredients especially for milk and soya.

Exclusion criteria

Pregnant or lactating mothers
Having known chronic disease conditions
Having a known allergy history for milk or any of the ingredients in the meal replacement.
History of any type of minor or major surgical procedure in the past 6 months.
Currently on diet prescriptions or participating in regular physical activity sessions

Suspension criteria

Subject’s request to discontinue the study.
Serious adverse events or unusual changes in clinical test results.
Principal investigator’s decision to terminate the study (low compliance rate, complications or unable to continue the study due to various reasons).

Randomization

Participants satisfying the eligibility criteria will be allocated to control and intervention groups equally (1:1) using the simple random sampling technique. A computer-generated random numbers sequence would be used for randomization. Eligibility evaluation and enrolment will be conducted by one independent investigator, while randomization will be done by another investigator.

Interventions

The test group will be provided with a 200 kcal meal replacement shake consisting 20.0 g of protein, 4.5 g of fat, 18.2 g of carbohydrate and 3.6 g of fiber with other vitamins and minerals (supplementary table 1). The meal replacement will be in powdered form, and participants will be instructed to prepare the liquid shake by mixing 53 g of powdered meal replacement with 400 mL of water. They will be asked to consume one serving of the meal replacement shake to replace dinner for 5 days of the week for a period of 8 weeks. The intervention group will be given sufficient meal replacement tins with a label indicating the ingredients and the preparation method. Participants will be instructed not to consume any additional food in between dinner in the evening, and breakfast the following morning. The breakfast and lunch meals will be recommended as normal meals (the meals that they habitually eat).

The control group will be asked to continue their usual dinner meals during the study period. In addition, both the groups will be given general dietary and lifestyle advice through distribution of leaflets which includes basic dietary advice according to Sri Lankan food based dietary guidelines. Both groups will be advised to continue their habitual physical activities.

Study groups

The treatment group will receive the meal replacement shake for their dinner. The control group will be advised to continue their routine dinner.

Study period

The study lasts for 8 weeks, and periodic measurements will take place at: screening (visit 0), 4 weeks (visit 1), 8 weeks (visit 2) (see Fig. 1).

Primary outcome

The primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline

Secondary outcomes

Changes in waist circumference, hip circumference, percentage body fat and fat free mass.
Change in systolic blood pressure and diastolic blood pressure.
Change in lipid profile from baseline - total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides.
Changes in glycemic control measures from baseline- fasting blood sugar, glycated haemoglobin (HbA1c).

Procedures

Recruitment

Healthcare employees of the Nawaloka Hospitals PLC, Colombo, Sri Lanka will be recruited on a voluntary basis for this study by advertising through notices and distribution of leaflets with study information. Informed written consent will be obtained from all study participants before recruitment.

Study schedule

Anthropometric measure, blood pressure, fasting plasma glucose, serum HbA1c and lipid profile will be measured at the time of recruitment of participants and will be repeated at the end of 8th week. However, anthropometry measures which will be again measured at the end of 4th week additionally. The details of items which will be measured at every visit are described in Table 1.

Measurement tools

Anthropometric measurements

Anthropometric measurements will be performed using calibrated equipment by trained personnel adhering to international recommendations. Height will be taken to the nearest 0.1 cm, as the maximum distance to the uppermost position on the head from heels, with the individual standing barefoot and in full inspiration using a calibrated stadiometer (Seca 213 portable stadiometer). Body weight will be measured to the nearest 0.1 kg using a calibrated digital weighing scale (Seca 813, Hamburg, Germany) with the participants wearing indoor light clothing and after emptying the bladder. Waist circumference will be measured midway between the iliac crest and the lower rib margin at the end of normal expiration using a plastic flexible tape to the nearest 0 .1 cm. Similarly, the hip circumference will be measured at the widest level over the greater trochanters level to the nearest 0 .1 cm. BMI will be calculated as body mass in kilograms divided by height in meters squared (kg/m²) and waist-to-hip ratio by dividing measured waist by hip circumference.

Body composition

Resistance (R) and reactance (X) will be assessed by bio-electrical impedance analysis (BIA) using a commercial portable device (Bodystat 1500, Bodystat Ltd, Isle of Man, British Isles) with hand-to-foot single frequency measurement while the subject remained supine. The participants will be asked to lie in supine position, and then the electrodes of the BIA device will be placed on the right hand and foot. Metal objects will be removed from the body, and measurements will be taken at room temperature. To calculate fat free mass and BF%, the resistance and reactance values will be applied to an ethnic-specific prediction equation developed for Asians [25].

Dietary measurements

A culturally validated Food Frequency Questionnaire (FFQ) will be used to obtain habitual intake of calories, macronutrients and micronutrients [26]. The energy content of each food component will be calculated using standard energy values for the portion sizes. The daily energy intakes are to be calculated using Nutri-Survey Software (EBISpro) modified with Sri Lankan food composition data.

Physical activity

Physical activity will be evaluated using the International Physical Activity Questionnaire (IPAQ) short version [27].

Biochemical analysis

A venous blood sample of 10–12 mL will be collected from each participant after an overnight fasting. Blood glucose, total cholesterol, triglycerides, and HDL-cholesterol will be determined using a Cobas c501 auto analyzer using an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics). LDL-cholesterol will be determined using the Friedewald formula. HbA1c will be evaluated by ion-exchange high-performance liquid chromatography.

Clinical examination

Seated blood pressure will be recorded to on two occasions after at least a 10-min rest using a digital blood pressure monitors (Omron Healthcare, Singapore).

Compliance calculation

Powdered meal replacement will be dispensed to each participant at baseline, end of the 2nd, 4th and 6th weeks. Participants will be instructed to return any unused meal replacement powder to the investigator at the end of the study. Compliance will be evaluated using the following formula:

Compliance % =\(\frac{\left(Distributed mealreplacement quantity–Remaining mealreplacement quantity\right)}{Distributed mealreplacement quantity}\times 100\)

In addition, researchers will phone participants periodically to monitor the consumption of the meal replacement. Each participant will be asked to record the meal replacement intake on each day in a compliance assessment sheet provided at baseline. At each visit these consumption records will be cross-checked with subjects. WhatsApp^® groups will be created for communication with intervention and control groups.

Statistical analysis

Using SPSS version 23 (SPSS Inc., Chicago, IL, USA), parametric and non-parametric statistical tests will be applied for data analysis. Summary statistics of each group will be computed and presented as mean, standard deviation and proportion. Using a paired t-test, the baseline and end of study characteristics as well as the laboratory results of the groups will be compared and a P value of < 0.05 will be considered significant. Multiple regression analysis will be used to assess other factors influencing the weight change. Distributions of continuous variables will be tested for normality using the Kolmogorov-Smirnov test. The non-parametric Mann-Whitney U test will be used for asymmetrical continuous variables.

Adverse effect evaluation

The meal replacement provides one-third of the Recommended Daily Allowance (RDA) of micro nutrients in addition to 20 g of protein and sufficient amount of fiber. Therefore, micronutrient deficiencies are very unlikely to occur. Furthermore, all participants will be thoroughly screened for any history of allergic reactions, particularly to milk products and other ingredients in the product. However, in the event of a probable adverse reaction the following precautions would ensure timely identification and management of patients:

Reporting—to monitor any potential adverse events, participants will have the opportunity to contact the researchers via WhatsApp^®, 24hr daily.
During follow-up visits, adverse events will be noted by history and examination and investigated in detail. All adverse effects observed will be documented in the case report form.
Management—in the event of an adverse reaction requiring in-hospital management, the facilities and expert management would be available at the Nawaloka Hospital PLC, Colombo, Sri Lanka.
Termination of study—the complete clinical trial will be terminated prematurely if there is evidence that the safety of the trial participants can no longer be guaranteed, or new scientific information arises during course of the clinical trial regarding safety of the patients.

Data collection

Data collection will be performed according to the standard operating procedures (SOPs) by the principal investigator and trained research assistants.

Data management and monitoring

Storage: Data and documents will be locked and secured for 5 years, under the supervision of the principal investigator. Simultaneously, electronic copies will be stored in the Queensland University of Technology (QUT) Research Data Storage Service according to the QUT data management plan for the above prescribed period. Data will be entered by a minimum number of dedicated staff and saved in a dedicated computer with password protection. Samples will be stored in a secure facility, with measures taken to ensure that specimens are kept under correct and constant conditions at all times when in storage. Expert staff that are trained specifically in sample storage and transportation would ensure that all regulatory issues are properly handled.

Dissemination of study finding

The results of the above study will be disseminated as publications and presentations in national and international journals or scientific meetings.

Ethical considerations

The study protocol has been reviewed and approved by the Queensland University of Technology, Human Research Ethics Committee (UHREC approval no: 4878) and the institutional approval to conduct the study was taken from the Nawaloka Hospitals Research and Education Foundation, Colombo, Sri Lanka. The trial is also registered at the Australian New Zealand Clinical Trials Registry (ACTRN12622000231741). The study will be conducted in compliance with the Declaration of Helsinki and the good clinical practice guidelines. Any change in trial protocol will be notified to the relevant regulatory authorities and trial participants, with re-consent being taken from participants, if required.

This manuscript describes the protocol for a clinical trial designed to evaluate the effects of having a low calorie meal replacement dinner compared to habitual dinner meal on metabolic parameters of shift workers with obesity. To our knowledge this is one of the first randomized controlled trials evaluating the effects of a low calorie meal replacement dinner in shift workers with obesity.

The health sector is critical to any country's social and economic development. Therefore maintaining the wellbeing of healthcare employees is essential for improving the industry's quality, productivity, and profitability. Healthcare employees should be physically and of sound mental health, in order to provide constant attention to patients' requirements and ensure continuity of service in healthcare institutions. Most importantly, healthcare workers should be healthy role models for their patients. But, according to several studies, healthcare workers are no better than the general population when it comes to non-communicable diseases including obesity, diabetes, hypertension, as well as cardiovascular diseases [28].

Despite healthcare workers being well-informed about the causes and hazards of overweight and obesity, research in most countries have consistently indicated that they had a significantly greater risk of overweight, obesity and metabolic syndrome than the general population. The prevalence of overweight and obesity among health-care workers in Ghana ranged from 25.3–38.39% and 12.5–28.9% [29]. A study conducted in Botswana found that 34% of hospital employees had metabolic syndrome, 28.7% were obese, and 27.3% were overweight [30]. Another research of hospital employees found that late shift workers gained 4.3 kg more than day-shift workers (P = 0.02) after starting the current shift [31].

Habitual diet has great influence on the well-being of healthcare workers. However, most of the employees in this industry find it extremely difficult to have a balanced meal while coping with their workload, and demands of their work habits and associated lifestyle [32]. Several studies have shown an association between shift work and unhealthy eating habits, which could influence body composition and related health problems [33]. A study revealed that high energy density foods such as pastries, sweets, and sodas contributed to a significant portion of shift workers' daily energy intake, with 18.1%, 20.7%, and 21.6% accounting for morning, afternoon, and night shifts, respectively [34]. Also the shift schedules often affects meal times and meal patterns. According to recent research, the timing of food intake has a substantial impact on metabolism and weight management [35].

When planning appropriate nutritional interventions for night shift employees, it's also crucial to consider fatigue management and the unique requirements of night work [36], as food composition and meal distribution can have a significant impact on work performance and productivity [37]. In this study we selected a low-calorie meal replacement approach for shift workers with obesity as a weight loss strategy with the aim of improving behavioral compliance, increasing nutritional awareness, and its association with regular meals and less snacking [19]. Even in earlier research, participants who used meal replacements rated their dietary compliance and convenience higher than those who used traditional weight-loss regimens [38]. Therefore we believe that this would be a practical intervention to implement in the workplace.

Given the current interest in adopting low calorie meal replacement meals to achieve weight loss in obese shift workers, no well-designed randomized control trials have been undertaken for a sufficient time period to support or disprove this notion. Hence, the findings of this study will provide an alternative weight-loss for obese shift workers to lose their body weight without disrupting their work routine. Further, the findings of the current study would be useful in formulation new policies and designing new worksite weight loss interventions for employees’ obesity.

This article is in accordance with the study protocol Study protocol version 2.0, dated 01 November 2021. Enrollment for the trial has not yet started.

BIA: Bio-electrical impedance analysis; BMI: Body mass index ; ECLIA: Electrochemiluminescent immunoassay; FFQ: Food frequency questionnaire; HDL: High-density lipoprotein; IPAQ: International Physical Activity Questionnaire; LDL: Low-density lipoprotein; QUT: Queensland University of Technology; RDA: Recommended Daily Allowance; SOPs: Standard operating procedures; SPIRIT: Standard Protocol Items Recommendations for Interventional Trials; WHO: World Health Organization

Ethics approval and consent to participate

This study protocol has been approved by the Queensland University of Technology (QUT) Human Research Ethics Committee (UHREC approval no: 4878). All participants will sign a written informed consent form.

Consent for publication

Not applicable

Availability of data and materials

Not applicable.

Competing interests

The authors declare no conflict of interest regarding the publication of this paper

Funding

The authors declare that they received no funding for the conduction of this study

Authors’ contributions

PS and RJ substantially contributed to the general idea and design of the study. PS, RJ, NK, TP planned the data collection and analysis. PS drafted the manuscript. RJ, NK and TP revised the manuscript. All authors have read and consented to the manuscript.

Acknowledgements

None

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You are reading this latest preprint version

Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial

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Version 1

Abstract

Figures

Introduction

Methods

Objectives and hypothesis

Study design and setting

Sample size

Population

Inclusion and exclusion criteria

Primary outcome

Secondary outcomes

Procedures

Recruitment

Study schedule

Measurement tools

Anthropometric measurements

Dietary measurements

Compliance calculation

Statistical analysis

Adverse effect evaluation

Data collection

Data management and monitoring

Dissemination of study finding

Ethical considerations

Discussion

Trial Status

Abbreviations

Declarations

References

Supplementary Files

Status:

Version 1