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Trial registered on ANZCTR


Registration number
ACTRN12615001092583
Ethics application status
Approved
Date submitted
23/09/2015
Date registered
19/10/2015
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing and interrupting prolonged sitting time in adults with pre-diabetes: A pilot study of feasibility and acceptability of a real-life intervention
Scientific title
A pilot study of feasibility and participant acceptability of a proposed future randomised trial, investigating whether an intervention incorporating environmental and behavioural change, in overweight and pre-diabetic adults, leads to improvements in glucose and insulin metabolism, and reductions in sitting time and accumulated bouts of prolonged sitting
Secondary ID [1] 287519 0
Nil known
Universal Trial Number (UTN)
U1111-1174-7778
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-diabetes 296297 0
Condition category
Condition code
Public Health 296574 296574 0 0
Health promotion/education
Metabolic and Endocrine 296575 296575 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a 4-week multi-component intervention aiming to reduce total sitting time by 1 hour/day, with an emphasis on interrupting prolonged bouts of sitting and sustaining this target for the duration of the 4-week intervention. The intervention consists of three distinct evidence-based components: (1) Health coaching - consisting of one in-person and two telephone sessions, conducted by project staff trained in motivational interviewing techniques and study protocols, providing individually tailored support for sitting time reduction and breaking up of prolonged sitting time. The initial in-person session will occur at baseline and will assist in the installation of the sit-stand workstation (see below). Furthermore, the initial session will provide feedback on baseline levels of sitting time, assess and enhance motivation, and identify/set goals related to opportunities to reduce and breakup prolonged sitting in both the home and work environment. Total time for the in-person session (including workstation installation and coaching) is expected to be approximately 60 minutes. The two telephone sessions will be split evenly across the following four weeks of the intervention. These sessions will be guided by an intervention protocol checklist and will be brief (approximately 10 minutes). The sessions will be used to check on progress in reducing sitting at home and at work, address problems, revise goals and reinforce gaol attainment. (2) Providing a sit-stand workstation at their place of employment. (3) Providing a self-monitoring and behavioural prompting tool in the form of a wrist worn activity monitor (jawbone or similar) to continually monitor their movement patterns (via a steps function). Through the associated mobile application (IOS and Android), participants can also set goals around these behaviours, and request regular prompts to interrupt their idle states (via vibrations). Wearing the device will be self-directed and will only be used as an intervention-delivery tool, not to gather outcome data.
A number of assessments proposed in the future RCT will be performed pre and post the 4-week intervention. These include: analysis of blood glucose and insulin metabolism (primary outcome); sitting time and accumulated bouts of prolonged sitting, body composition, blood pressure, fasting blood tests investigating cardio-metabolic markers, endothelial function, and interviewer-administered questionnaires to explore participants’ overall experience and acceptability of the intervention (secondary outcomes).
Intervention code [1] 292926 0
Behaviour
Intervention code [2] 292927 0
Lifestyle
Intervention code [3] 292928 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296191 0
Postprandial plasma glucose levels: (mean area under the curve [AUC]). Plasma glucose concentrations will be assessed during a 3 hour 75 g Oral Glucose Tolerance Test
Timepoint [1] 296191 0
Blood samples for glucose analysis will be collected every 1/2 hour for 3 hours - both at baseline and after the 4 week intervention is completed.
Primary outcome [2] 296308 0
Postprandial plasma insulin levels: (mean area under the curve [AUC]). Plasma insulin concentrations will be assessed during a 3 hour 75 g Oral Glucose Tolerance Test
Timepoint [2] 296308 0
Blood samples for insulin analysis will be collected every 1/2 hour for 3 hours - both at baseline and after the 4 week intervention is completed.
Secondary outcome [1] 317753 0
Physical activity: Sedentary behaviour and physical activity time will be assessed in the study using accelerometers (Actigraph model GT3Xplus) and inclinometers (model activPAL). An activity diary will be used in combination with the two devices to allow participants to record when they put on/took off the devices or engaged in non- ambulatory physical activities (ie. cycling, swimming) that are not able to be recorded by the accelerometer. Participants will also enter work start/finish times in the diary on those work days the devices are worn.
Timepoint [1] 317753 0
The accelerometer and inclinometer will be worn for ten consecutive days at baseline (prior to the intervention) and for the last ten consecutive days of the intervention.
Secondary outcome [2] 317754 0
Body composition: Total body and regional lean tissue mass will be measured using a BE Lunar iDXA scanner, housed at Baker IDI.
Timepoint [2] 317754 0
Pre and post the 4 week intervention.
Secondary outcome [3] 317755 0
Anthropometry: Weight, height and waist circumference will be measured using standard techniques.
Timepoint [3] 317755 0
Pre and post the 4 week intervention.
Secondary outcome [4] 317756 0
Endothelial function: Flow mediated dilatation with ultra-sound will be used to assess arterial health.
Timepoint [4] 317756 0
Pre and post 4 week intervention
Secondary outcome [5] 317757 0
Blood pressure: Following 5 minutes of quiet sitting, three separate blood pressure readings will be taken with the average recorded.
Timepoint [5] 317757 0
Pre and post 4 week intervention.
Secondary outcome [6] 317758 0
Diet: A 3-day food diary will be analysed for energy and macronutrient composition.
Timepoint [6] 317758 0
Three consecutive days at baseline (prior to the intervention) and for the last three consecutive days of the intervention.
Secondary outcome [7] 317759 0
Participant acceptability: Participants will complete an interviewer-administered questionnaire exploring their overall experience and acceptability of the intervention.
Timepoint [7] 317759 0
Post intervention only.

Eligibility
Key inclusion criteria
From the general community, overweight or obese adults aged between 45-65 years, with diagnosed pre-diabetes (within the last 6 months), impaired fasting glucose and/or impaired glucose tolerance according to current World Health Organisation diagnostic criteria, who are working at least 0.5 full-time equivalent and able to elicit employer permission to install the provided sit-stand workstation.
Minimum age
45 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously diagnosed diabetes and/or use of glucose altering medications, regularly engaged in moderate-vigorous exercise (>150 min/week for > 3 months), self reported to be sitting <9 hours per day, pregnant, current smoker, and known physical activity contraindications and/or medical illness that may limit their ability to participate in the intervention.

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)
Participants living in the Melbourne metropolitan area will be recruited via multiple strategies. Baker IDI databases containing details of current patients and previous participants, who have consented to be contacted for future studies will be our initial target group. This will be in combination with advertising via local newspapers, radio, social media, and newsletters/flyers with various locations (e.g. Baker IDI clinics, general practitioner clinics, allied health clinics, community houses and senior centres). Should the need arise we will also engage an external patient recruitment agency (Trialfacts, which has a database containing >25,000 Australian patient and healthy volunteers) to facilitate participant recruitment. Participants will initially be screened for eligibility via a telephone-administered interview based the above criteria and on the AUSDRISK tool (a score >6 indicating a significant risk of being prediabetic). If Trialfacts are engaged, they will carry out the initial phone screening and provide us a list of potential candidates. Following successful completion of phone screening, the trial coordinator will explain the project in lay terms, initially over the telephone. Inclusion/exclusion criteria will be discussed and, provided the patient is suitable and willing to take part, they will be forwarded a copy of the patient information and consent forms (PICF) by mail or email. They will be called back in the following days to discuss any concerns, before be asked to give verbal consent to undergo, just, the screening OGTT and 10-day physical activity monitoring - the final steps to confirm eligibility. The Baker IDI study coordinator will send pathology request forms (via mail) to each potential participant to attend a local pathology centre (Melbourne Pathology) to complete a standard 75-g OGTT to confirm prediabetes status. Once confirmed as having pre-diabetes, participant’s sitting time and physical activity will be monitored for 10 consecutive days via an inclinometer and accelerometer. These monitors will be posted out to participants with instructions on their operation. While being state of the art devices, externally they are very simple, and participants will not be required to do anything to operate them apart from following basic instructions on how to wear them. They will allow for assessment of habitual activity and ensure that only participants who sit for long periods (>9 hours per day) and are inactive (<30 min/day of moderate/vigorous physical activity) are included. Once eligibility is confirmed, participants will be invited into the Physical Activity Lab at Baker IDI where, once again, the study will be explained to them. The participant will then be asked to reread the PICF and decide if they are willing to give informed consent for remaining intervention components of the study.
As this is a pilot study to assess the feasibility of a future trial, there will be no randomisation or allocation of a treatment as all participants will complete the intervention in its entirety.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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)
Efficacy
Statistical methods / analysis
As this is a pilot study to assess the feasibility of a future trial, statistical analysis was not performed to determine sample size. Sample size was determined through discussions between principal and associate investigators.
Regarding statistical analysis to evaluate data, Subjective evaluations of intervention components and assessment procedures will be provided by participants at the completion of the intervention via questionnaires and interviews. To inform an evaluation of intervention fidelity, all intervention contacts will be tracked regarding attempts, completions and duration of calls. The iAUC will be calculated using the trapezoidal method. Differences between baseline and post-intervention in cardio-metabolic outcomes will be tested using paired t-tests.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10604 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292098 0
Government body
Name [1] 292098 0
National Health and Medical Research Council (NHMRC)
Address [1] 292098 0
National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
Country [1] 292098 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
Baker IDI Heart and Diabetes Institute
Physical Activity Laboratory
Level 4
The Alfred Centre
75 Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 290777 0
None
Name [1] 290777 0
Address [1] 290777 0
Country [1] 290777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293585 0
Alfred Hospital Ethics Committee (EC00315)
Ethics committee address [1] 293585 0
Office of Research Governance
Ground Floor Linay Pavilion
The Alfred
55 Commercial Road
Melbourne
VIC 3004
Ethics committee country [1] 293585 0
Australia
Date submitted for ethics approval [1] 293585 0
10/09/2015
Approval date [1] 293585 0
07/10/2015
Ethics approval number [1] 293585 0
423/15

Summary
Brief summary
Rationale
Based on evidence from the AusDiab study, it is estimated that at least 2 million Australians have prediabetes, a condition that carries a 10–20 fold increased risk of developing T2D. In people with prediabetes, too much sitting – accumulated throughout the day and across multiple settings – is now understood to be related to increased risk of T2D, microvascular and macrovascular complications, and premature mortality. This is distinct from the known adverse consequences of too little exercise. Descriptive epidemiological evidence shows that a high proportion of adults aged in their 50s and 60s can spend more than 9 hours each day sitting. Significant health benefits can be gained through innovative and feasible lifestyle-change strategies that take a ‘whole-of-day’ approach to reducing and interrupting the multiple consecutive hours spent sitting.
Those at risk of diabetes are a high priority group for preventive initiatives. Given the escalating healthcare system, societal and economic burden associated with diabetes and cardiovascular disease, this will be an important and timely study and a vital step in developing affordable and effective evidence-based interventions to reduce and interrupt prolonged sitting, which will ultimately contribute to Australia’s national strategy for the prevention of major non-communicable diseases.

Aim
We aim to undertake pilot work to examine the short-term feasibility and acceptance of a proposed future randomised controlled trial (RCT) investigating the long-term efficacy of an intervention to reduce and interrupt prolonged sitting time in overweight or obese adults with prediabetes. Over a 4-week period we will examine the acceptability of participants to take part in the trial, and scrutinise the feasibility of interventions and assessment procedures proposed in the future trial. Conducting this study allow us to refine the design and/or methodology for the proposed future trial.

Hypothesis
We hypothesise that the intervention and assessment procedures used over the 4-week trial period will prove feasible to be included in the proposed future trial. Furthermore, participants will adapt and maintain compliance with the intervention and, on reflection, will express good acceptability of the intervention.
We also hypothesise that the 4-week intervention will show small improvements from baseline in postprandial insulin and glucose, sitting time and bouts of prolonged sitting, endothelial function, body composition, blood pressure, and cardiometabolic markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60522 0
Prof David Dunstan
Address 60522 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Research Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 60522 0
Australia
Phone 60522 0
+61 3 8532 1873
Fax 60522 0
+61 3 8532 1150
Email 60522 0
David.Dunstan@bakeridi.edu.au
Contact person for public queries
Name 60523 0
Mr Ian Mullis
Address 60523 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Research Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 60523 0
Australia
Phone 60523 0
+61 3 8532 1932
Fax 60523 0
+61 3 8532 1150
Email 60523 0
Ian.Mullis@bakeridi.edu.au
Contact person for scientific queries
Name 60524 0
Prof David Dunstan
Address 60524 0
Physical Activity Laboratory
Baker IDI Heart and Diabetes Research Institute
Level 4, Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 60524 0
Australia
Phone 60524 0
+61 3 8532 1873
Fax 60524 0
+61 3 8532 1150
Email 60524 0
David.Dunstan@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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary