ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000231741

Ethics application status

Approved

Date submitted

31/01/2022

Date registered

9/02/2022

Date last updated

11/01/2023

Date data sharing statement initially provided

9/02/2022

Date results information initially provided

11/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the effectiveness of a low calorie meal replacement dinner compared to traditional dinner meal on health parameters of shift workers with obesity

Scientific title

Investigating the efficacy of a low calorie meal replacement dinner compared to traditional dinner meal on metabolic parameters of shift workers with obesity

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will be provided with a meal replacement shake consisting of 201kCal of energy, 20.0 g of protein, 4.5 g of fat, and 18.2 g of carbohydrate per serving. The meal replacement will be in powdered form and the subjects will be advised to prepare the liquid shake by mixing 53g of powdered meal replacement with 200 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. They will be given sufficient meal replacement tins with a label indicating the ingredients and the preparation method. Subjects will be instructed not to consume any additional food in between dinner or breakfast. The breakfast and lunch meals will be recommended as normal meals.
In addition, participants of the intervention group will be asked to maintain a compliance log by reporting their intake to monitor adherence to the intervention.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control will receive no meal replacement diet and they will be asked to continue their usual dinner meals during the study period.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of participants with a minimum 5% reduction in body weight from baseline.
Body weight will be measured using a calibrated digital weighing scale, Seca 813, Hamburg, Germany)

Timepoint [1]

Body weight will be measured at 3 time points. During the recruitment, at 4th week and at the completion of the study at 8th week.

Secondary outcome [1]

Secondary Outcome 1:
Other anthropometric measures such as, height, waist circumference (WC), and hip circumference (HC)

Assessment method:
Height will be taken to the nearest 0.1 cm, as the maximum distance to the uppermost position on the head from heels, 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). Waist and hip circumferences will be measured using a plastic flexible tape to the nearest 0.1 cm.

Timepoint [1]

Will be measured at recruitment, at 4th week and at the completion of the study at 8th week.

Secondary outcome [2]

Secondary Outcome 2:
Systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Assessment method:
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).

Timepoint [2]

Will be measured at recruitment (0 week) and at the end of the study (8 weeks)

Secondary outcome [3]

Secondary Outcome 3:
Lipid profile (total cholesterol, LDL, HDL and TAG).

Assessment method:
Will be assessed by blood tests. A venous blood sample of 10-12 ml will be collected from each participant after an overnight fasting. Serum glucose, total cholesterol, triglycerides, and HDL cholesterol were determined using a Cobas c501 auto analyzer using an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics).

Timepoint [3]

Will be measured at recruitment (0 week) and at the end of the study (8 weeks)

Secondary outcome [4]

Secondary Outcome 4:
Glycemic control measures (FBS, HbA1c)

Assessment method:
Assessed by blood test

Timepoint [4]

Will be measured at recruitment (0 week) and at the end of the study (8 weeks)

Secondary outcome [5]

Secondary Outcome 5:
Body composition parameters

Assessment method::
Will be assessed using a bio-electrical impedance analyser (Bodystat, Douglas, Isle of Men, UK).

Timepoint [5]

Will be measured at recruitment (0 week) and at the end of the study (8 weeks)

Eligibility

Key inclusion criteria

a) Permanent employees aged 18-60 years
b) Have been working shifts continuously for past 12 months and continue during whole study period which is 8 weeks
c) Working at least 3 night shifts/week
d) Participants with BMI >27.5 kg/m2
e) Not having any allergies to any of the known food ingredients in the meal replacement

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) Pregnant or lactating mothers
b) Having known chronic disease conditions
c) History of any type of minor or major surgical procedure in the past 6 months.
d) Currently on diet prescriptions or participating regular physical activity sessions/programs ( e.g. yoga class)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer-generated random numbers sequence would be used for randomization.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculation:
A sample of 44 healthcare employees who engage in shift work will be recruited for the study after screening for eligibility The minimum sample size was 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 test group and 10% of participants in the control group would lose at least 5% of their baseline body weight after 8 weeks. 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 overweight or obesity (BMI >27.5 kg/m2) will be recruited for the study. Sample size was calculated using www.powerandsamplesize.com.(http://powerandsamplesize.com/Calculators/Compare-2-Proportions/2-Sample-Equality)

Statistical analysis:
Using SPSS version 23 (SPSS Inc., Chicago, IL, USA), parametric and non-parametric statistical tests will be applied. Summary statistics of each group will be computed and presented as mean, standard deviation and proportions. Using a paired t-test, the baseline and end of study characteristics 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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

14/03/2022

Actual

7/03/2022

Date of last participant enrolment

Anticipated

Actual

14/03/2022

Date of last data collection

Anticipated

Actual

23/05/2022

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sri Lanka

State/province [1]

Colombo (Western province)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology (QUT)

Address [1]

School of Exercise & Nutrition Sciences,
Faculty of Health,
Queensland University of Technology (QUT),
Kelvin Grove QLD 4059, Australia.

Country [1]

Australia

Primary sponsor type

University

Name

Queensland University of Technology

Address

School of Exercise & Nutrition Sciences,
Faculty of Health,
Queensland University of Technology (QUT),
Kelvin Grove QLD 4059, Australia.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Faculty of Medicine, University of Colombo Sri Lanka

Address [1]

Health and Wellness Unit,
The Faculty of Medicine,
University of Colombo,
No 25, Kynsey Road,
Colombo 00800,
Sri Lanka

Country [1]

Sri Lanka

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University Human Research Ethics Committee (UHREC), Queensland University of Technology (QUT)

Ethics committee address [1]

University Human Research Ethics Committee (UHREC),
Queensland University of Technology (QUT),
Victoria Park Road
Kelvin Grove Qld 4059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/10/2021

Approval date [1]

12/01/2022

Ethics approval number [1]

4878

Summary

Brief summary

This project aims to investigate if having a meal replacement product for dinner during night shift days is an effective strategy to achieve a body weight loss in shift workers with obesity compared to a conventional dinner.
The research will be a parallel, randomized controlled clinical trial and will be conducted at the Nawaloka Hospital PLC, Colombo, Sri Lanka. The participants will be the shift working hospital staff with obesity. The treatment group will receive 5 meal replacement dinner meals per week. The control group will have their regular dinner meal. In addition, both groups will be given lifestyle advices and basic dietary advices according to Sri Lankan food based dietary guidelines. The study will be conducted for a period of 8 weeks and the evaluations of anthropometric and biochemical parameters will be done at the beginning, at the 4th week, and at the end of the 8th week of the study. The hypothesis being tested in this trial is to improve the metabolic parameters in the intervention group by achieving a minimum of 5% body weight loss. Please refer to the attached protocol for further details

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Piumika Sooriyaarachchi

Address

School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.

Country

Australia

Phone

+94719327283

Fax

piumika.sooriyaarachchi@hdr.qut.edu.au

Contact person for public queries

Name

Mrs Piumika Sooriyaarachchi

Address

School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.

Country

Australia

Phone

+94719327283

Fax

piumika.sooriyaarachchi@hdr.qut.edu.au

Contact person for scientific queries

Name

Mrs Piumika Sooriyaarachchi

Address

School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.

Country

Australia

Phone

+94719327283

Fax

piumika.sooriyaarachchi@hdr.qut.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Only aggregate data will be available

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
14786	Ethical approval	piumika.sooriyaarachchi@hdr.qut.edu.au		383400-(Uploaded-30-01-2022-18-05-07)-Study-related document.pdf
14787	Study protocol	piumika.sooriyaarachchi@hdr.qut.edu.au
14788	Informed consent form	piumika.sooriyaarachchi@hdr.qut.edu.au		383400-(Uploaded-30-01-2022-22-16-17)-Study-related document.doc
14849	Other	piumika.sooriyaarachchi@hdr.qut.edu.au	Information sheet Advertising materials Data col... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A qualitative exploration of the experiences of shift workers participated in a low-calorie meal replacement dietary intervention.	2023	https://dx.doi.org/10.1136/bmjopen-2023-072012
Embase	Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial.	2022	https://dx.doi.org/10.1186/s13063-022-06784-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically