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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
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] 306183 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 324991 0
Condition category
Condition code
Diet and Nutrition 322434 322434 0 0
Obesity
Public Health 322437 322437 0 0
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] 322666 0
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] 330199 0
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] 330199 0
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] 405274 0
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] 405274 0
Will be measured at recruitment, at 4th week and at the completion of the study at 8th week.
Secondary outcome [2] 405275 0
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] 405275 0
Will be measured at recruitment (0 week) and at the end of the study (8 weeks)
Secondary outcome [3] 405276 0
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] 405276 0
Will be measured at recruitment (0 week) and at the end of the study (8 weeks)
Secondary outcome [4] 405277 0
Secondary Outcome 4:
Glycemic control measures (FBS, HbA1c)

Assessment method:
Assessed by blood test
Timepoint [4] 405277 0
Will be measured at recruitment (0 week) and at the end of the study (8 weeks)
Secondary outcome [5] 405626 0
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] 405626 0
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?
No
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
44
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 24519 0
Sri Lanka
State/province [1] 24519 0
Colombo (Western province)

Funding & Sponsors
Funding source category [1] 310526 0
University
Name [1] 310526 0
Queensland University of Technology (QUT)
Country [1] 310526 0
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] 311874 0
University
Name [1] 311874 0
Faculty of Medicine, University of Colombo Sri Lanka
Address [1] 311874 0
Health and Wellness Unit,
The Faculty of Medicine,
University of Colombo,
No 25, Kynsey Road,
Colombo 00800,
Sri Lanka
Country [1] 311874 0
Sri Lanka

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310150 0
University Human Research Ethics Committee (UHREC), Queensland University of Technology (QUT)
Ethics committee address [1] 310150 0
University Human Research Ethics Committee (UHREC),
Queensland University of Technology (QUT),
Victoria Park Road
Kelvin Grove Qld 4059
Ethics committee country [1] 310150 0
Australia
Date submitted for ethics approval [1] 310150 0
18/10/2021
Approval date [1] 310150 0
12/01/2022
Ethics approval number [1] 310150 0
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 116658 0
Mrs Piumika Sooriyaarachchi
Address 116658 0
School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.
Country 116658 0
Australia
Phone 116658 0
+94719327283
Fax 116658 0
Email 116658 0
[email protected]
Contact person for public queries
Name 116659 0
Piumika Sooriyaarachchi
Address 116659 0
School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.
Country 116659 0
Australia
Phone 116659 0
+94719327283
Fax 116659 0
Email 116659 0
[email protected]
Contact person for scientific queries
Name 116660 0
Piumika Sooriyaarachchi
Address 116660 0
School of Exercise and Nutrition Sciences,
Faculty of Health,
Queensland University of Technology,
Kelvin Grove Qld 4059.
Country 116660 0
Australia
Phone 116660 0
+94719327283
Fax 116660 0
Email 116660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate data will be available


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMeal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial.2022https://dx.doi.org/10.1186/s13063-022-06784-x
EmbaseA qualitative exploration of the experiences of shift workers participated in a low-calorie meal replacement dietary intervention.2023https://dx.doi.org/10.1136/bmjopen-2023-072012
N.B. These documents automatically identified may not have been verified by the study sponsor.