Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000250831
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
8/03/2021
Date last updated
2/04/2024
Date data sharing statement initially provided
8/03/2021
Date results information initially provided
13/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Netflix and Move: Does interrupting streaming in the evening with activity impact metabolism in adults?
Scientific title
Netflix and Move: Does interrupting streaming in the evening with short bouts of activity impact postprandial glycemia and sleep in adults?
Secondary ID [1] 303338 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glycemia 320585 0
Prolonged sitting 320586 0
Postprandial insulinemia 320587 0
Postprandial lipaemia 320588 0
Poor sleep quality 320589 0
Condition category
Condition code
Diet and Nutrition 318444 318444 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 318445 318445 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete, in a random order, two, 4 h intervention sessions from 6 pm to 10 pm and one ~15 min introductory session. Each sessions will be separated by a minimum of six days. All sessions will be held at the University of Otago and will be conducted by an Assistant Research Fellow. A session attendance checklist will be collected so monitor participant movement through the intervention components.
Introductory Session:
The introductory session will take place at least seven days prior to the first 4h intervention session. During the introductory session, participants will have the opportunity to ask any questions they might have. A participant booklet will be provided and explains. This will contain information about the study, research team contact details and space to record session dates and times. Blood pressure, weight and height measurements will be taken. The regular activity breaks video which will be used during the 4h intervention sessions will be shown to each participant; they will have the opportunity to practice the movements and form will be corrected if required. A wrist worn accelerometer will be given to the participant as well as a sleep and wear time diary (which will be explained). Participants will be instructed to wear the accelerometer for seven consecutive days. Lastly, participants will be scheduled for their two 4h evening sessions.
The two intervention sessions are as follows:
1. Uninterrupted sitting: Participants will remain seated for the duration of the session while streaming their choice of entertainment on a device.
2. Sitting interrupted by regular activity breaks: Participants will complete a 3 min activity break every 30 min throughout the 4 h intervention session. At all other times they will remain seated and will stream their choice of entertainment on a device.
During each 4 h intervention session participants will be provided with a standardised dinner (of beef curry, rice and naan bread with margarine spread) at baseline and dessert (of boysenberry slice) at 120 min. Test meal serving sizes will be calculated using the Schofield equation to determine each participants estimated energy requirement (EER).
To ensure dietary intake is standardised during the day before the arrive for the intervention/control session standardised meals for breakfast (of cereal, milk, yoghurt and orange juice), morning tea (of caramel slice), lunch (of chicken noodle soup, ciabatta bread with margarine spread and cheese) and an optional snack (oaty slice bar) will be provided. All meals will need to be consumed prior to 2pm on the day of the 4 h intervention session.
Intervention code [1] 319647 0
Lifestyle
Comparator / control treatment
Uninterrupted sitting.
Control group
Active

Outcomes
Primary outcome [1] 326408 0
Postprandial glucose response will be assessed by collecting blood samples at the time point listed below at each 4 h intervention session and using them to calculate area under the curve. Concentrations of glucose will be measured using enzymatic colorimetric methods.
Timepoint [1] 326408 0
Baseline, 30 min after dinner test meal, 45 min are dinner test meal, 60 min, 120 min, 150 min (30 min after dessert test meal), 165 min (45 min after dessert test meal), 180 min and 240 min.
Secondary outcome [1] 391377 0
Postprandial insulin response will be assessed by collecting blood samples at the time point listed below at each 4 h intervention session and using them to calculate area under the curve. Concentrations of insulin will be measured using an Electrochemiluminescent Immunoassay.
Timepoint [1] 391377 0
Baseline, 30 min after dinner test meal, 45 min are dinner test meal, 60 min, 120 min, 150 min (30 min after dessert test meal), 165 min (45 min after dessert test meal), 180 min and 240 min
Secondary outcome [2] 391378 0
Postprandial triglyceride response will be assessed by collecting blood samples at the time point listed below at each 4 h intervention session and using them to calculate area under the curve. Concentrations of triglycerides will be measured using enzymatic colorimetric methods.
Timepoint [2] 391378 0
Baseline, 30 min after dinner test meal, 45 min are dinner test meal, 60 min, 120 min, 150 min (30 min after dessert test meal), 165 min (45 min after dessert test meal), 180 min and 240 min.
Secondary outcome [3] 391379 0
The difference in sleep patterns will be measured by an ActiGraph accelerometer worn continuously on the non-dominant wrist.
Timepoint [3] 391379 0
Measured continuously for the 48 h following the two intervention sessions
Secondary outcome [4] 391380 0
The difference in sleep duration (time spent asleep) measured by accelerometery an ActiGraph accelerometer worn continuously on the non-dominant wrist. Sleep will be identified using a validated algorithm.
Timepoint [4] 391380 0
Two consecutive nights following the two intervention sessions.
Secondary outcome [5] 391382 0
The difference in sleep efficiency (percentage of time spent asleep between sleep onset and sleep offset) measured by accelerometery.
Timepoint [5] 391382 0
Two consecutive nights following the two intervention sessions.
Secondary outcome [6] 391383 0
The difference in sleep onset latency (duration from the time sleep was attempted until the onset of sleep is detected) measured by accelerometery.
Timepoint [6] 391383 0
Two consecutive nights following the two intervention sessions
Secondary outcome [7] 391417 0
To understand the perceived barriers and facilitators of performing regular activity breaks in the evening in a real life setting, assessed via ~30 minute semi-structured interviews.
Timepoint [7] 391417 0
At the completion of the study.
Secondary outcome [8] 392534 0
The difference in physical activity patterns will be measured by an ActiGraph accelerometer worn continuously on the non-dominant wrist. Established cut-offs for light and moderate-to-vigorous physical activity will be used to identify time spent in each.
Timepoint [8] 392534 0
Measured continuously for the 48 h following the two intervention sessions
Secondary outcome [9] 392536 0
The difference in sedentary behaviour patterns will be measured by an ActiGraph accelerometer worn continuously on the non-dominant wrist. Established cut-offs for sedentary behaviour will be used to identify time spent in each.
Timepoint [9] 392536 0
Measured continuously for the 48 h following the two intervention sessions
Secondary outcome [10] 432343 0
The difference in glycemic control (as measured by average glucose concentration and incremental and total area under the curve) and glycemic variability (as measured by standard deviation of glucose and continuous overall net glycemic action at 1 hour) will be assessed by collecting interstitial glucose levels every 15 minutes via a continuous glucose monitor. Total glycemic control and variability will be analysed, but will also be categorised into intervention (4-h period of the intervention session), 24- and 48-hours post intervention and nocturnal (defined by self-reported participant sleep and wake times) periods
Timepoint [10] 432343 0
Measured continuously from the day of the intervention to 48-hours following the two intervention sessions.
Secondary outcome [11] 432344 0
The difference in glycemic control (as measured by average glucose concentration and incremental and total area under the curve) and glycemic variability (as measured by standard deviation of glucose and continuous overall net glycemic action at 1 hour) will be assessed by collecting interstitial glucose levels every 15 minutes via a continuous glucose monitor. Total glycemic control and variability will be analysed, but will also be categorised into intervention (4-h period of the intervention session), 24- and 48-hours post intervention and nocturnal (defined by self-reported participant sleep and wake times) periods
Timepoint [11] 432344 0
Measured continuously from the day of the intervention to 48-hours following the two intervention sessions.

Eligibility
Key inclusion criteria
To be eligible for inclusion participants must be a non-smoker, self-report spending, on average, >5 h per day and >2 h in the evening engaged in sedentary behaviour and must not be taking any medication or dietary supplement that impact postprandial metabolism for example, metformin and/or niacin.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This study requires participants to complete short bouts of physical activity, therefore participants will be excluded if physical activity is not medically appropriate (all participants will be screened using the Physical Activity Readiness Questionnaire prior to the study). If participants have been told by a medical professional that they should avoid physical activity, they will be excluded. Lastly, participants with an intolerance or allergy to dairy or gluten will be asked not to participate as the test meal includes these food items.

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 randomisation sequence will be generated using STATA software and concealed electronically. The evening before each participant beings his or her first intervention session the next sequential randomization will be revealed and assigned. Participants will not be notified of which intervention they are completing until they arrive at their first session. By process of elimination however, participants will know their second intervention as soon as they begin the first 4 h intervention session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation stratified by BMI status for the order of interventions will be performed for each participant and will be generated using STATA software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
A sample size of 30 participants will give 80% power to the 5% significance level, to detect a difference of 0.4 standard deviations. A sample size of 30 will also allow us to detect differences in the secondary outcomes of 0.4 standard deviations of insulin and triglyceride area under the curve and 20 min of sleep duration.

Statistical methods
This study is a crossover design therefore each participant will be compared to themselves and the mean difference between the uninterrupted sitting and regular activity breaks for the whole group is determined. The mean difference in the outcomes of interest between the two interventions will be estimated, along with 95% confidence intervals using mixed regression models where the intervention condition is the exposure variable, participant ID as a random effect and controlling for randomisation order. Effect moderation by weight status and sedentary and physical activity patterns will be done by mixed regression models stratified by the moderating variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2021
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
13/07/2021
Date of last data collection
Anticipated
Actual
1/10/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23426 0
New Zealand
State/province [1] 23426 0
Otago

Funding & Sponsors
Funding source category [1] 307755 0
Government body
Name [1] 307755 0
Health Research Council of New Zealand
Country [1] 307755 0
New Zealand
Primary sponsor type
Individual
Name
Meredith Peddie
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country
New Zealand
Secondary sponsor category [1] 308456 0
Individual
Name [1] 308456 0
Jill Haszard
Address [1] 308456 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country [1] 308456 0
New Zealand
Other collaborator category [1] 281634 0
Individual
Name [1] 281634 0
Rachel Brown
Address [1] 281634 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country [1] 281634 0
New Zealand
Other collaborator category [2] 281635 0
Individual
Name [2] 281635 0
Rachael Taylor
Address [2] 281635 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country [2] 281635 0
New Zealand
Other collaborator category [3] 281636 0
Individual
Name [3] 281636 0
Elaine Hargreaves
Address [3] 281636 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country [3] 281636 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307776 0
University of Otago Human Ethics Committee
Ethics committee address [1] 307776 0
University of Otago
PO Box 56
Dunedin, 9018
Ethics committee country [1] 307776 0
New Zealand
Date submitted for ethics approval [1] 307776 0
27/11/2020
Approval date [1] 307776 0
11/12/2020
Ethics approval number [1] 307776 0
H20/161

Summary
Brief summary
This study will provide important evidence around how reducing sedentary behaviour in the evening by regularly performing short bouts of resistance activity may improve postprandial metabolism and sleep, both of which are important for cardio-metabolic health. We will conduct a randomised, crossover study involving 30 participants from across the BMI range. The study will include two experimental intervention sessions: uninterrupted sitting in the evening and sitting interrupted by regular activity breaks, separated by a minimum of six days washout period. Blood samples will be collected intermittently throughout the two intervention sessions and will be used to measure postprandial glucose, insulin and triglyceride responses. Sleep duration, efficiency and onset latency will be measured via accelerometer, and glucose control measured by continuous glucose monitoring during the 48 h after the intervention sessions. Mixed model regression will be used to examine differences in the effect of the two interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108458 0
Dr Meredith Peddie
Address 108458 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country 108458 0
New Zealand
Phone 108458 0
+6434798358
Fax 108458 0
Email 108458 0
[email protected]
Contact person for public queries
Name 108459 0
Miss Jennifer Gale
Address 108459 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country 108459 0
New Zealand
Phone 108459 0
+64 212790230
Fax 108459 0
Email 108459 0
[email protected]
Contact person for scientific queries
Name 108460 0
Dr Meredith Peddie
Address 108460 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9018
Country 108460 0
New Zealand
Phone 108460 0
+6434798358
Fax 108460 0
Email 108460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying the published results.
When will data be available (start and end dates)?
Will be available immediately following publication and will end five years following the publication.
Available to whom?
Data will be available on a case by case basis at the discretion of the primary investigator.
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Access will be subject to approval by the primary investigator. Contact via email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gale, J. T., Wei, D. L., Haszard, J. J., Brown, R.... [More Details]

Documents added automatically
No additional documents have been identified.