Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000371594
Ethics application status
Approved
Date submitted
10/03/2024
Date registered
28/03/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Netflix and Move 2: Exploring the feasibility of breaking up sitting time in the evening with regular activity breaks
Scientific title
Breaking up free living sedentary time in the evening with regular activity breaks in adults: A feasibility and pilot study
Secondary ID [1] 310681 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged sitting 331592 0
Postprandial glycemia 331593 0
Poor sleep 331594 0
Glycemic control 331595 0
Condition category
Condition code
Diet and Nutrition 328326 328326 0 0
Obesity
Metabolic and Endocrine 328327 328327 0 0
Other metabolic disorders
Public Health 328328 328328 0 0
Epidemiology
Public Health 328329 328329 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a 7 day baseline period followed by a two-week intervention period and two-week follow up period.
INTRODUCTORY SESSION
The introductory session will take place at the Department of Human Nutrition Mellor Laboratories (University of Otago, Dunedin. New Zealand), where the research assistant will:
1. Measure height, weight, and blood pressure (in triplicate 1 min apart; after 15-min seated rest) using standardised procedures. If blood pressure is greater than 140/90 mmHg and participants have not already obtained medical clearance, then they will be asked to contact their GP to gain clearance to participate in the study.
2. Discuss the participant’s typical evening to identify the period in which the participant is mostly sedentary (e.g., 1700 to 2100 hours), and the time the participant usually consumes their evening meal.
3. Fit participants with two activity monitors: an ActiGraph GT3+ accelerometer, which they will be asked to wear on their non-dominant wrist, and an ActivPal3 which is attached to the midpoint of the front of the right thigh with adhesive dressing. Participants will be instructed to wear both activity monitors continuously (24 hours a day) for a seven-day period to assess usual sleep and physical activity patterns.
4. Explain the wear time diary to the participant in which they will record times either accelerometer was removed (such as when showering or playing contact sport), time participating in physical activity (as some static activities such as cycling on a stationary bike are not captured accurately) and sleep information (time attempted sleep, time woke up).
5. Fit participants with a Freestyle Libre Pro iQ continuous glucose monitor (CGM) which will allow for a non-invasive measurement of glycaemic response every 15 minutes. In the wear time diary participants will also be asked to keep an estimated diet record of all food and drink consumed during the defined evening sedentary period, as well as a record of their large evening meal if it was outside of this time period.

INTERVENTION
After completing the seven-day baseline period participants will attend a second session at Mellor Laboratories to return the accelerometer and have the CGM removed. During this visit the research assistant will:
1. Instruct participants to complete the Pittsburgh Sleep Quality Index questionnaire to assess baseline self-perceived sleep quality.
2. Briefly discuss the evidence around prolonged sitting as a risk factor and the benefits associated with taking regular activity breaks.
3. Assist participants to download the Stretch Minder application (Better Primates Lab Limited, Hong Kong) on to their mobile device and guide the participant though the use of the application including showing links to the activity breaks exercise videos.
4. Program the application to provide alerts to complete activity breaks every 30 min during the specified evening sedentary period, for the next two-weeks (for example, if a participant identified 1700 to 2100 h as the period in which they habitually engage in sedentary time in the evening, this would be entered into the Stretch Minder Mobile application so that alerts would begin at 1700, and continue every 30-min until 2100 h, every night, for two-weeks). As this is a paid application, participants will be provided with an app store voucher to activate a one-month subscription, (participants will be guided to switch off the auto renewal to avoid further subscription fees).
5. Develop an individualised contingency plan which involves participants identifying potential barriers they may face when implementing the activity breaks and strategies to overcome these barriers.
6. Fit participants with new activity monitors (ActiGraph GT3+ and ActivPal3), and a new CGM to wear continuously over the 2-week intervention period. Wear time and information about food and beverage consumption will be monitored in the same manner as the baseline period.
7. Provide participants with a booklet which will include the contingency plan and space for participants to record 1) sleep/wake and wear time, 2) evening meal, beverage, and snack consumption and 3) what helped or hindered them to performing breaks each day.

During the personalised evening period participants will receive alerts on their mobile phone from the Stretch Minder application. Before beginning the activity break, participants will be able to select one, three-minute exercise video to complete (of light-moderate intensity). Available exercise videos built into the Stretch Minder app will be restricted to those that include simple body weight resistance exercises (e.g., squats, calf raises and lunges), therefore excluding static stretching or movements designed to be done while sitting at a desk such as neck rotations. The exercise videos depict the exercises participants should complete, so they can follow along. Additionally, the videos contain a timer and the ability to mute the instructions so that breaks could be completed without the audio instruction interrupting television viewing. This overcomes one of the reported barriers to performing the activity breaks reported from our previous work.
Participants will receive two follow up phone calls during the two-week intervention period (on day three and day seven). During these calls the research assistant will discuss how the participant is finding the intervention and to revisit any contingency plans, if needed. After the two-week period participants will attend a visit to Mellor Laboratories to return all equipment including the accelerometer, sleep, wear time and evening food diary and CGM and to complete the final Pittsburgh Sleep Quality and COM-B questionnaires.

FOLLOW UP PERIOD
At the end of the 2-week intervention period, participants will be reminded to use the StretchMinder mobile application over the next two weeks (weeks 3 and 4). Together with the research assistant, participants will revise their contingency plan to discuss the key factors that hindered them to perform the activity breaks during the 2-week active intervention period and encouraged to use strategies that they identified as helpful over the previous two weeks. Application engagement will be measured as the average number of time per week the application is opened and an activity breaks video is started. This information will be provided from the developers of the Mobile Application via a Data Sharing Agreement, and with consent from the participants

QUALITATIVE FEEDBACK
At the end of the follow up period participants will participate in a face-to-face semi-structured interview where they will be asked about their overall experience completing the activity breaks at home. Questions will explore participants’ experiences of the intervention, what helped and what hindered them to perform the intervention and what was missing from the intervention as it is currently designed. Questions will specifically ask what supported or hindered their ability to perform the breaks, explore the use of the mobile application during the intervention, and during the follow up period, as well as asking participants to reflect on potential positive and/or negative outcomes experienced from performing the activity breaks (Appendix I). Interviews will be recorded, and transcripts analyzed using inductive thematic analysis (Braun & Clarke, 2006). At the end of the interview participants will be provided with a $100 supermarket voucher in recognition of the actual or reasonable costs associated with participating in this study.
Intervention code [1] 327087 0
Lifestyle
Intervention code [2] 327088 0
Behaviour
Comparator / control treatment
Participants will be their own control and the findings will be compared to the 7-day baseline period where no intervention is made to their habitual evening sitting time.
Control group
Active

Outcomes
Primary outcome [1] 336180 0
The change in the average daily number of activity breaks performed during the evening, between the 7-day baseline period and 2-week intervention period.
Timepoint [1] 336180 0
Baseline (7 days), end of 2-week intervention.
Secondary outcome [1] 427221 0
The consistency of the increase in the number of regular activity breaks performed, during the evening, across the two-week intervention period.
Timepoint [1] 427221 0
Baseline (7 days), end of 2-week intervention.
Secondary outcome [2] 431210 0
The change in sleep patterns between the baseline period (7-days) and 2-week intervention.
Timepoint [2] 431210 0
Baseline (first 3 days), beginning of intervention (first 3 days) and end of intervention (final 3 days).
Secondary outcome [3] 431211 0
The change in physical activity patterns between the baseline period (7-days) and 2-week intervention.
Timepoint [3] 431211 0
Baseline (first 3 days), beginning of intervention (first 3 days) and end of intervention (final 3 days).
Secondary outcome [4] 431212 0
The difference in glycemic control between the baseline period (7-days) and 2-week intervention.
Timepoint [4] 431212 0
Baseline, end of 2-week intervention
Secondary outcome [5] 431213 0
The difference in glycemic variability between the baseline period (7-days) and 2-week intervention.
Timepoint [5] 431213 0
Baseline, end of 2-week intervention
Secondary outcome [6] 431214 0
Validity of an activity breaks detection algorithm
Timepoint [6] 431214 0
Baseline, beginning of intervention (first 4 days) end of intervention (final 4 days)
Secondary outcome [7] 431215 0
Barriers to performing activity breaks in a free-living environment.
Timepoint [7] 431215 0
Completion of the study
Secondary outcome [8] 432660 0
The change in participants’ capability to perform activity breaks in the evening at home.
Timepoint [8] 432660 0
Baseline (7-days) and the 2-week intervention period.
Secondary outcome [9] 432661 0
The difference in engagement with the mobile application, between the 2-week intervention period and 2 week follow up.
Timepoint [9] 432661 0
2-week intervention period and 2-week follow up period.
Secondary outcome [10] 433125 0
The difference in daytime glycemic control between the baseline period (7-days) and 2-week intervention.
Timepoint [10] 433125 0
Baseline, end of 2-week intervention
Secondary outcome [11] 433126 0
The difference in evening glycemic control between the baseline period (7-days) and 2-week intervention.
Timepoint [11] 433126 0
Baseline, end of 2-week intervention
Secondary outcome [12] 433127 0
The difference in nocturnal glycemic control between the baseline period (7-days) and 2-week intervention.
Timepoint [12] 433127 0
Baseline, end of 2-week intervention
Secondary outcome [13] 433128 0
The difference in daytime glycemic variability between the baseline period (7-days) and 2-week intervention.
Timepoint [13] 433128 0
Baseline, end of 2-week intervention
Secondary outcome [14] 433129 0
The difference in evening glycemic variability between the baseline period (7-days) and 2-week intervention.
Timepoint [14] 433129 0
Baseline, end of 2-week intervention
Secondary outcome [15] 433130 0
The difference in nocturnal glycemic variability between the baseline period (7-days) and 2-week intervention.
Timepoint [15] 433130 0
Baseline, end of 2-week intervention
Secondary outcome [16] 433131 0
Facilitators to performing activity breaks in a free-living environment.
Timepoint [16] 433131 0
Completion of the study
Secondary outcome [17] 433132 0
The change in participants’ opportunity to perform activity breaks in the evening at home.
Timepoint [17] 433132 0
Completion of the study
Secondary outcome [18] 433133 0
The change in participants’ motivation to perform activity breaks in the evening at home.
Timepoint [18] 433133 0
Completion of the study
Secondary outcome [19] 433134 0
The change in self-rated sleep quality and sleep disturbances.
Timepoint [19] 433134 0
Baseline period and end of 2-week intervention.
Secondary outcome [20] 436616 0
Change in blood pressure
Timepoint [20] 436616 0
Secondary outcome [21] 436617 0
Change in blood pressure
Timepoint [21] 436617 0
Baseline period, end of 2-week intervention and end of 4-week follow up.

Eligibility
Key inclusion criteria
Self report habitually accumulating more than 3 hours of sitting time in the evening.
Have a smart phone that is compatible with the Stretch Minder Application.
Must be able to ambulate unaided (i.e., not using a wheel chair, crutches or other assisted device)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self report habitually accumulating less than 3 hours of sitting time in the evening.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
3/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 25815 0
New Zealand
State/province [1] 25815 0
Otago

Funding & Sponsors
Funding source category [1] 314900 0
Charities/Societies/Foundations
Name [1] 314900 0
Otago Medical Research Foundation
Country [1] 314900 0
New Zealand
Primary sponsor type
Individual
Name
Dr Meredith Peddie
Address
P.O. Box 5726 Dunedin 9054 New Zealand
Country
New Zealand
Secondary sponsor category [1] 317149 0
Individual
Name [1] 317149 0
Jennifer Gale
Address [1] 317149 0
Country [1] 317149 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313894 0
Univeristy of Otago Human Ethics Committee
Ethics committee address [1] 313894 0
Ethics committee country [1] 313894 0
New Zealand
Date submitted for ethics approval [1] 313894 0
11/09/2023
Approval date [1] 313894 0
01/10/2023
Ethics approval number [1] 313894 0
H23/105

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

Contacts
Principal investigator
Name 129702 0
Dr Meredith Peddie
Address 129702 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9018
Country 129702 0
New Zealand
Phone 129702 0
+6434798358
Fax 129702 0
Email 129702 0
[email protected]
Contact person for public queries
Name 129703 0
Jennifer Gale
Address 129703 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9018
Country 129703 0
New Zealand
Phone 129703 0
+643 479 7959
Fax 129703 0
Email 129703 0
[email protected]
Contact person for scientific queries
Name 129704 0
Meredith Peddie
Address 129704 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9018
Country 129704 0
New Zealand
Phone 129704 0
+64 34798358
Fax 129704 0
Email 129704 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.