Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000798460
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
20/06/2016
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Activity during television advertisement breaks to offset the adverse effects of prolonged sitting: The ‘Active Ads’ study
Scientific title
Activity during television advertisement breaks to offset the adverse effects of prolonged sitting: The ‘Active Ads’ study
Secondary ID [1] 289160 0
nil
Universal Trial Number (UTN)
Trial acronym
The ‘Active Ads’ study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
impaired glucose tolerance 298698 0
obesity 298699 0
endothelial function 298700 0
insulin levels 298701 0
Condition category
Condition code
Metabolic and Endocrine 298745 298745 0 0
Diabetes
Public Health 298754 298754 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a randomised crossover trial involving sedentary individuals or couples. The study will involve, one familiarisation session and two acute experimental conditions (each of approx. 4 hours duration) at the Physical Activity Laboratory. Both conditions will occur in the evening (between 6 and 10pm) as this is the time period of peak TV viewing time in most adults and coincides with the post-evening meal period.
Following successful completion of the phone screening, the study coordinator will explain the project in lay terms, initially over the telephone. Inclusion/exclusion criteria will be discussed and, provided the participant is suitable and willing to take part, they will be sent (either by mail or email) a copy of the patient information and consent form (PICF), to get informed consent for wearing two objective activity monitors in the week prior to the trial (for a 10 day period) and to record their diet (for a 5 day period) during the trial week. They will be called back in the following days to discuss any concerns, before being asked to send back the signed PICF. Once the Baker IDI study coordinator receives the PICF, they will send the activity monitors and diaries (with instructions) via mail to each potential participant which they will wear for a 10 day period, starting Thursday (in the week prior to the trial) until Sunday (in the week of trial).
In order to allow orientation with the testing procedures and measurement devices, a baseline familiarisation session will take place at the Baker IDI Physical Activity Laboratory on the day preceding the first condition. During the familiarization visit (Monday) the study staff will fit participants with a continuous glucose monitor (CGM) which they will wear for a 5 day period during the trial week (Monday to Friday evening). The CGM will require the participants to take 3 blood samples (just before breakfast, lunch and dinner) with a finger prick blood taking device provided by the research staff. Study staff will also show them the 24 hour ambulatory blood pressure monitor (24 hour ABPM) which they will wear from Tuesday to Wednesday night and Thursday to Friday night. In addition anthropometric measurements and demonstration and practice of the simple resistance exercises will also be done. Activity monitors (which will have been posted the week prior) along with the activity diaries and food diaries will be checked as well.
Participants will be instructed not to alter their habitual pattern of daily activities while involved in the trial. To assess compliance and habitual physical activity, participants will be instructed on how to fit two objective activity monitors in the week prior to the trial – an accelerometer (Actigraph model GT3X) worn on the hip, and an inclinometer (activPAL) worn on the thigh. The objective activity monitoring will be used in combination with an activity diary.
The study will involve two acute (4 hour) experimental conditions, supervised by the study staff, in the evening after work (Tuesday and Thursday), and separated by a 1-day washout period. The research group consisting of the coordinator and research assistant will be responsible for monitoring adherence to the interventions;
1) Uninterrupted sitting: Participants will sit for the entire duration of a TV movie (roughly for 3 hours), after consumption of an evening meal, including during intermittent (every 20 minute) advertisement breaks (of 3 minutes).
2) Interrupted sitting: Identical procedure to Condition 1, except that participants will get up and perform simple resistance exercises during the advertisement breaks. The 3 minutes will be divided into a total of nine 20 second segments, alternating between body weight half-squats, calf raises and brief gluteal contractions in-between single leg knee raises (total exercise time equals to 27 minutes). This interchange between movements will provide rest for the corresponding muscle groups between each activity segment, allowing for continual muscle activation over the 3 minute period. To ensure appropriate movement standardisation, tempo, and correct ‘form’, participants will mimic a pre-prepared video recording which will be practiced prior to their first condition visit (see Familiarisation). Range of motion (knee/hip 45 to 90 degrees for half-squats/knee raises) will also be tailored to the individual ahead of time. Activity intensity will be monitored using heart rate and the Borg Scale of relative perceived exertion (RPE).
Participants will be instructed to minimise excessive movement when sitting; only rising from the seated position to void. As boredom has been shown to influence food intake the movie will be self-selected by participants from a library of pre-determined series.

On each testing day, participants will consume standardised dinner meal according to their body mass and height. To employ a pragmatic approach and assimilate a typical Western dietary composition, the ‘real world’ dinner meal will comprise of 45% of estimated daily energy requirements, with a macronutrient profile of 53-55% energy from carbohydrate, 12-15% energy from protein, and 30-33% energy from fat.

After the completion of the trial, the participants will remove all the devices (CGM, 24 hour ABPM, and activity monitors), put in a pre-prepared envelope and mail it back to Baker IDI.
Intervention code [1] 294685 0
Lifestyle
Comparator / control treatment
Uninterrupted sitting: Participants will sit for the entire duration of a TV movie (roughly 3 hours), after consumption of an evening meal, including during intermittent (every 20 minute) advertisement breaks (of 3 minutes).
Control group
Active

Outcomes
Primary outcome [1] 298250 0
Postprandial glucose response from the venous blood and Continuous Glucose Monitoring System (CGMS)
Timepoint [1] 298250 0
Venous blood samples collected every 30 minutes during the experimental condition and CGMS for 24 hours after each experimental condition.
Primary outcome [2] 298251 0
Post prandial insulin response from the venous blood samples
Timepoint [2] 298251 0
Blood samples collected every 30 minutes during the experimental condition
Secondary outcome [1] 323659 0
Hunger will be measured using a validated Visual Analogue Scales (VAS) for appetite
Timepoint [1] 323659 0
Prior to the meal, after consumption of the evening meal (30min), 1.5 hours after the commencement of the movie and at the end of the movie.
Secondary outcome [2] 323660 0
Fatigue will be measured using a validated Visual Analogue Scales (VAS) for fatigue
Timepoint [2] 323660 0
prior to the meal, after consumption of the evening meal (30min), 1.5 hours after the commencement of the movie and at the end of the movie.
Secondary outcome [3] 323663 0
A composite secondary outcome of Endothelial function of femoral and brachial artery using high-resolution Doppler ultrasound.
Timepoint [3] 323663 0
On the trial days, assessed at baseline and at the end of the trial condition
Secondary outcome [4] 323665 0
Blood Pressure using 24 hour Ambulatory Blood Pressure Monitor
Timepoint [4] 323665 0
for the 24 hour period following each experimental condition
Secondary outcome [5] 323671 0
A composite secondary outcome consisting of total cholesterol and triglycerides levels from the venous blood samples
Timepoint [5] 323671 0
Blood samples collected every 30 minutes during the experimental condition

Eligibility
Key inclusion criteria
Couples or individuals, having a BMI of more than or equal to 25 kg/m^2 but less than 40 kg/m^2, currently watching more than 2 hours of television per day and English-speaking
Minimum age
25 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, employment in a non-sedentary occupation (eg tradesperson), regularly engaged in moderate-intensity exercise more than or equal to 150 min/week for more than 3 months, current smokers, diagnosed diabetes,use of glucose or lipid lowering or antidepressant medications, known physical activity contraindications, major illness or physical problems (acute or chronic) that may limit the participant's ability to perform the activity bouts.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The power calculation for the cross-over design is based on mean changes in the primary endpoints for the study (mean changes in area under the curve [AUC] for plasma glucose, insulin and serum triglycerides). Estimates for population variability in these parameters (mean AUC ratio for glucose 1.1, Standard Deviation [SD] : 0.01; and mean AUC ratio for insulin 1.6, SD: 0.3) is based on AusDiab data. Assuming a conservative correlation of 0.50 between repeated measures of the parameters, it is estimated that 15 subjects would be required to detect a clinically-meaningful change for the primary outcomes between the control (uninterrupted sitting) and the experimental condition (active ad breaks) with 80% power and at a 0.05 probability level (2-tailed test). To compensate for subject withdrawal, 20 couples (40 participants) will be recruited. Generalized linear mixed models with random intercepts will be used to evaluate the differential effects of the experimental conditions on the selected outcomes. A probability level of 0.05 will be adopted. All statistical analyses will be performed using Stata 14 for Windows (StataCorp LP).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/07/2016
Actual
11/10/2016
Date of last participant enrolment
Anticipated
5/12/2016
Actual
9/02/2017
Date of last data collection
Anticipated
Actual
9/03/2017
Sample size
Target
40
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293565 0
Charities/Societies/Foundations
Name [1] 293565 0
Shepherd Foundation
Country [1] 293565 0
Australia
Primary sponsor type
Individual
Name
Professor David Dunstan
Address
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292384 0
None
Name [1] 292384 0
Address [1] 292384 0
Country [1] 292384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294989 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 294989 0
Ethics committee country [1] 294989 0
Australia
Date submitted for ethics approval [1] 294989 0
04/05/2016
Approval date [1] 294989 0
15/06/2016
Ethics approval number [1] 294989 0
Project 199/16

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

Contacts
Principal investigator
Name 65690 0
Prof David Dunstan
Address 65690 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65690 0
Australia
Phone 65690 0
+61 3 8532 1873
Fax 65690 0
+61 3 8532 1150
Email 65690 0
David.Dunstan@bakeridi.edu.au
Contact person for public queries
Name 65691 0
Jasmeen Oberoi
Address 65691 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65691 0
Australia
Phone 65691 0
+61 3 8532 1862
Fax 65691 0
+61 3 8532 1150
Email 65691 0
jasmeen.oberoi@bakeridi.edu.au
Contact person for scientific queries
Name 65692 0
Rachel Climie
Address 65692 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65692 0
Australia
Phone 65692 0
+61 3 8532 1834
Fax 65692 0
+61 3 8532 1150
Email 65692 0
rachel.climie@bakeridi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval was not obtained for data sharing


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.