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Trial registered on ANZCTR


Registration number
ACTRN12617000791336
Ethics application status
Approved
Date submitted
23/05/2017
Date registered
30/05/2017
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Shifting the Risk Study (Investigating meal timing and heart health in shift workers)
Scientific title
Does modifying the timing of meal intake improve cardiovascular risk factors: A pilot intervention in shift workers with abdominal obesity.
Secondary ID [1] 290887 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 301599 0
Diabetes 301600 0
Condition category
Condition code
Cardiovascular 301305 301305 0 0
Coronary heart disease
Metabolic and Endocrine 301306 301306 0 0
Diabetes
Inflammatory and Immune System 301307 301307 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PROCEDURES
Participants will be randomised to begin with the Intervention period or the Control period. There will be a minimum of two week washout between the two periods.

Intervention period (manipulation of meal times)

Participants will be asked to avoid food intake for a five hour period during the night, for a continuous four week period (minimum 28 days). They will receive a face-to-face individual meeting with a dietitian, who will provide them with a tailored eating plan, to redistribute the timing of food intake. During the four week Intervention period, participants will also be asked to:
- Complete one 24-hour food recall each week (four in total).
- Wear a Sensewear activity monitor for 5 days. The Sensewear activity monitors are used to collect physical activity information.

During the study period, participants will also be asked to collect urine for a continuous 48-hour period (maximum of two occasions). This is used to analyse the concentration of aMT6s, which is the primary urinary metabolite of melatonin.

In order to measure metabolic outcomes, participants will be asked to partake in acute meal challenges: once at baseline and once after the Intervention period.

Each acute meal challenge will run for approximately 7 hours (~8am – 2:30pm). After a 10-hour fast, participants will arrive at the Be Active Sleep and Eat (BASE) facility at 8am. Anthropometric (weight, waist circumference) and body composition measures will be taken. A trained nurse or phlebotomist will then insert a cannula in the participant’s forearm and a baseline blood sample will be taken. Participants will be provided with a high fat breakfast meal (~45% energy from fat), to be consumed within 15 minutes. Blood samples will be taken for a total of 6 hours post-meal (timing begins at commencement of meal intake): at 15, 30, 45, 60, 90, 120 minutes and then hourly for the next 4 hours. The maximum amount of blood that will be collected during this 6-hour period is 120ml. Participants will be permitted water (but no other food or drinks) and are to remain sedentary during this period. Participants will also be asked to complete surveys regarding their shift schedule, sleep, exercise habits and general well-being during this period.

WHO WILL DELIVER THE INTERVENTION:
Participants’ progress through the entire study will be monitored by two PhD students from the Department of Nutrition, Dietetics and Food of Monash University, Australia. The dietetic consult will be performed by an Accredited Practising Dietitian. Trained nurses or phlebotomists will perform cannulation and blood draws during the acute meal challenges.

MODE OF DELIVERY
The intervention of the study is avoiding food intake at night for a specified period. Participants will receive an initial face-to-face individual meeting with a dietitian, who will help them reorganise their usual meal pattern to avoid food intake between the specified hours. As the participants will be asked to maintain the types and amount of food they usually eat, changing only the timing of food intake, regular follow-up with the dietitian will not be necessary. However, they are encouraged to contact the dietitian or other research team members by phone or email if they have difficulties maintaining this intervention.

LOCATION
The participants will be free-living. The acute meal challenges will be conducted in the Be Active Sleep and Eat (BASE) Research Facility at Monash University (Notting Hill, Victoria, Australia).

DURATION AND TIME FRAME
The entire study will be approximately 13 weeks in duration. Participants will be in the Intervention period for a continuous 4 weeks (28 days minimum). The acute meal challenges will be conducted once at baseline and once after the Intervention period. Each of acute meal challenges will be approximately 7 hours in duration. Participants will meet with the dietitian during the acute meal challenge prior to the commencement of Intervention period, this will take 30 minutes to an hour.

TAILORING
Individually tailored meal plans will be provided, in regards to the redistribution of food intake to other times of the day to avoid the specified period during the night. Participants’ food preferences and usual meal times will vary; dietary advice will be based on these.

MAINTAINING ADHERENCE
During the Intervention Period, participants will be sent automated text messages on every night shift, to remind them not to eat at night. 24-hour food recalls will be completed once a week during the Intervention period to help monitor compliance. Participants will be contacted via phone on their first day off after a continuous row of night shifts and be asked to recall their intake of the day prior.
Intervention code [1] 297315 0
Lifestyle
Comparator / control treatment
PROCEDURE
Control period (ad-libitum eating)
Participants will be asked to maintain/return to their habitual dietary intake for a continuous four week period (minimum 28 days). During the four week Control period, participants will also be asked to:
- Complete one 24-hour food recall each week (four in total).
- Wear a Sensewear activity monitor for 5 days. The Sensewear activity monitors are used to collect physical activity information.

Participants will partake in another acute meal challenge after the Control Period (i.e.: total of three in entire study). The procedure of the acute meal challenge is described in the Intervention section above.

LOCATION
The participants will be free-living. The acute meal challenges will be conducted in the Be Active Sleep and Eat (BASE) Research Facility at Monash University (Notting Hill, Victoria, Australia).

DURATION AND TIME FRAME
Participants will be in Control period for a continuous 4 weeks (28 days minimum). The acute meal challenge will be conducted once after the Control period and it will take approximately 7 hours.

MAINTAINING ADHERENCE
24-hour food recalls will be completed once a week during the Control period to help monitor compliance. Participants will be contacted via phone on their first day off after a continuous row of night shifts and be asked to recall their intake of the day prior.
Control group
Active

Outcomes
Primary outcome [1] 301276 0
Lipid concentration as assessed during acute meal challenges. Serum lipid concentration will be analysed using the Indiko Clinical and Speciality Chemistry System.
Timepoint [1] 301276 0
Lipid concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for lipids will be taken at baseline, then at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 minutes post-meal.
Primary outcome [2] 301368 0
Glucose concentration as assessed during acute meal challenges. Plasma glucose concentration will be analysed using the Indiko Clinical and Speciality Chemistry System.
Timepoint [2] 301368 0
Glucose concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for glucose will be taken at baseline, then at 15, 30, 45, 60, 90, 120 and 180 minutes post-meal.
Secondary outcome [1] 332181 0
Insulin concentration as assessed during acute meal challenges. Plasma insulin concentration will be analysed using commercial immunoassay kits.
Timepoint [1] 332181 0
Insulin concentration will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for insulin will be taken at baseline, then at 15, 30, 45, 60, 90, 120 and 180 minutes post-meal.
Secondary outcome [2] 332182 0
Fasting endothelial function blood markers, analysed using commercial ELISA kits.
Timepoint [2] 332182 0
Fasting concentration of endothelial function blood markers will be measured:
1) after the 4 week Intervention and
2) after the 4 week Control period.
Secondary outcome [3] 334830 0
A composite of inflammatory cytokines (e.g.: TNF-alpha, IL-8 and other novel markers), as assessed during the acute meal challenge. Plasma/serum inflammatory cytokines concentration will be analysed using the Magpix Clinical Diagnostics Instrument.
Timepoint [3] 334830 0
Inflammatory cytokines concentrations will be measured during the acute meal challenge undertaken:
1) after the 4 week Intervention and
2) after the 4 week Control period.

During each 6-hour acute meal challenge, blood samples for inflammatory cytokines will be taken at baseline, then at 1, 2, 4 and 6 hours post-meal.

Eligibility
Key inclusion criteria
Night shift workers (working at least 4 night shifts per fortnight) with abdominal obesity.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Day time workers
- Have been working night shift for less than one consecutive year
- Working less than 4 night shifts per fortnight on average
- Waist circumference below 80 cm (all females), below 94 cm (Non-Asian males) or below 90 cm (Asian males)
- Diagnosed with diabetes, high blood lipids or cardiovascular disease
- Taking medication for diabetes, high blood pressure, high blood lipids, cardiovascular disease or those known to alter body composition or metabolism (e.g.: thyroxin, insulin sensitisers, glucocorticoids or anti-depressants).
- Pregnant, planning a pregnancy or breastfeeding
- Those who consume 4 or more standard drinks on one occasion, at a "daily or almost daily" occurrence

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be generated by a researcher who is not involved in determining participant eligibility. The allocation sequence will be kept in a password-protected computer file; which the researchers involved in screening the participants will not be able to access.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (with random block sizes) using a computerised sequence generator will determine the order in which the participants receive the intervention. Block sizes will be kept confidential to the researchers randomising participants to the order of intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
In the absence of literature with study design and endpoints similar to that proposed in this study, a power calculation could not be conducted. The current study serves as a pilot study, to determine the required sample size to achieve study objectives. We aim to have 20 participants complete the study. Accounting for a 30% attrition rate, we will aim to recruit 28 participants.

Analysis plan:
Primary outcomes (postprandial lipids and glucose) will be compared between two periods: post-Intervention and post-Control period. This will be conducted using the CROS analysis method (1), which takes into account period effects. Briefly, CROS analysis (1) will involve an analysis of variance (ANOVA) with lipid and glucose concentration at the end of each period as the outcome variables and patient, period and intervention group as the factor variables. Similar methods will be used to assess the difference between the two interventions for secondary outcomes. In cases where the baseline levels of an outcome are deemed important confounders, analysis of co-variance (ANCOVA) will be used. For instances where assumptions of ANOVA are not met, a non-parametric equivalent test will be used.

Reference:
1. Jones B, Kenward MG. Design and Analysis of CrossOver Trials. 2nd ed. London: Chapman and Hall, 2003.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2017
Actual
24/08/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
11/07/2018
Date of last data collection
Anticipated
1/12/2018
Actual
11/10/2018
Sample size
Target
28
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295761 0
Charities/Societies/Foundations
Name [1] 295761 0
National Heart Foundation (Vanguard grant)
Country [1] 295761 0
Australia
Primary sponsor type
Individual
Name
A/Prof Maxine Bonham
Address
Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.
Country
Australia
Secondary sponsor category [1] 294606 0
Individual
Name [1] 294606 0
Dr Catherine Huggins
Address [1] 294606 0
Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.
Country [1] 294606 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297642 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297642 0
Ethics committee country [1] 297642 0
Australia
Date submitted for ethics approval [1] 297642 0
04/05/2017
Approval date [1] 297642 0
17/05/2017
Ethics approval number [1] 297642 0
8619

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71634 0
A/Prof Maxine Bonham
Address 71634 0
Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.
Country 71634 0
Australia
Phone 71634 0
(+61) 3 9902 4272
Fax 71634 0
Email 71634 0
maxine.bonham@monash.edu
Contact person for public queries
Name 71635 0
Maxine Bonham
Address 71635 0
Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.
Country 71635 0
Australia
Phone 71635 0
(+61) 3 9902 4199
Fax 71635 0
Email 71635 0
med.shiftwork.study@monash.edu
Contact person for scientific queries
Name 71636 0
Maxine Bonham
Address 71636 0
Department of Nutrition, Dietetics and Food. Monash University. Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168.
Country 71636 0
Australia
Phone 71636 0
(+61) 3 9902 4272
Fax 71636 0
Email 71636 0
maxine.bonham@monash.edu

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9958Study protocolBonham MP, Leung GKW, Davis R, et al. Does modifying the timing of meal intake improve cardiovascular risk factors? Protocol of an Australian pilot intervention in night shift workers with abdominal obesity. BMJ Open 2018;8:e020396. doi: 10.1136/bmjopen-2017-020396  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes rearranging meal times at night improve cardiovascular risk factors? An Australian pilot randomised trial in night shift workers.2021https://dx.doi.org/10.1016/j.numecd.2021.03.008
N.B. These documents automatically identified may not have been verified by the study sponsor.