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Trial registered on ANZCTR


Registration number
ACTRN12618001411235
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
23/08/2018
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing sitting time in older adults with non-insulin dependent type 2 diabetes
Scientific title
Effectiveness of the 'Small Steps' intervention in decreasing sitting time in older adults with non-insulin dependent type 2 diabetes: a pre-post study
Secondary ID [1] 295638 0
None
Universal Trial Number (UTN)
U1111-1217-9469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-insulin dependent type 2 diabetes 308972 0
Condition category
Condition code
Metabolic and Endocrine 307871 307871 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Small Steps’ intervention. The intervention will be administered by the Principal Investigator, and will consist of a one hour face-to-face session at the GP Plus, Marion, where participants are guided through three activities in a workbook: i) review of their assessed sedentary time and education on sitting and health; ii) normative feedback on sedentary time, using quartiles to compare an average Australian of similar age and gender; and iii) guided goal-setting to reduce sedentary time and increase the number of breaks in prolonged sedentary time. The guided goal-setting will involve a ‘small steps’ approach, whereby each participant will choose six ways to decrease their sitting time from a list which combines pre-specified behavioural items with suggestions of their own arising from the interview. Each goal will be incrementally integrated into the participant’s habitual behaviour each week for six weeks (e.g. Week 1 goal: “I am going to stand up during two TV ad breaks”, Week 2 goal: “I am going to stand up while I talk on the phone” + week 1 goal). A summary of the specific goal-setting plan will be provided to participants at the end of the face-to-face session. Participants will be required to self-monitor their goals daily with the completion of a simple checklist (e.g. “Today, did you achieve your goal of standing up during two TV ad breaks? Yes/No. If not, why not?”). Weekly phone calls will be completed by a member of the research team to provide support, and remind participants to build on their previous week’s goal.
Intervention code [1] 301955 0
Lifestyle
Intervention code [2] 301956 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306847 0
Objectively-measured sitting time
The total duration and bouts of sitting time will be measured using the activPAL3 monitor (PAL Technologies, Glasgow, Scotland), the gold standard for postural allocation. This small device is worn attached to the thigh and is used to provide detailed, time-stamped information about bouts of time spent sitting. The activPAL monitor is the most precise measure of sitting time in older adults (correlation of 0.99 compared with direct observation).
Timepoint [1] 306847 0
Baseline (7 day / 24 hour monitoring period pre-intervention) and post-intervention (7 day / 24 hour monitoring period post the 6 week intervention period)
Primary outcome [2] 307164 0
Objectively-measured physical activity
Physical activity will be measured by the GeneActiv wrist worn activity monitor which has been shown to be a reliable and valid measurement tool capable of classifying the intensity of physical activity in adults.
Timepoint [2] 307164 0
Baseline (7 day / 24 hour monitoring period pre-intervention) and post-intervention (7 day / 24 hour monitoring period post the 6 week intervention period)
Secondary outcome [1] 349929 0
Types of sedentary behaviour
The MARCA use of time interview will be used to measure self-reported types of sedentary behaviour to inform the intervention. The MARCA uses a structured phone interview with participants recalling their last two days to construct daily activity profiles. Use of the MARCA allows for the identification of discrete activity sets within the sedentary behaviour domain. For example, the average time devoted to specific activities such as screen time (TV and/or computer use); quiet time (reading, lying awake, and listening to music); passive transport (car travel); eating; and other sedentary activities (playing musical instruments, or sitting and talking) can be identified. The MARCA has demonstrated test-retest reliability in adults for sleep, physical activity levels (PAL) and screen time (ICC 0.99–1.00). The MARCA has been shown to be a valid measure of total daily energy expenditure when compared with the current gold standard of doubly-labelled water (r = 0.70) and of PAL when compared with accelerometry-derived PAL in adolescents and adults (r = 0.72).
Timepoint [1] 349929 0
Baseline and post-intervention (up to one week post intervention completion)
Secondary outcome [2] 349930 0
Blood glucose levels
Interstitial glucose concentration will be measured pre- and post-intervention using Continuous Glucose Monitoring System (CGMS) to determine if periods of activity / inactivity are associated with glucose excursions.
Timepoint [2] 349930 0
Baseline (7 day / 24 hour monitoring period pre-intervention) and post-intervention (7 day / 24 hour monitoring period post the 6 week intervention period)
Secondary outcome [3] 349931 0
Quality of life
Quality of life will be assessed with the Audit of Diabetes Dependent Quality of Life (ADDQoL19), which has been validated in an Australian population.
Timepoint [3] 349931 0
Baseline and post-intervention (up to one week post intervention completion)

Eligibility
Key inclusion criteria
A sample of 30 older adults with non-insulin dependent T2DM will be recruited through the South Australian Diabetes and Endocrine Service (SADES) at the GP SuperPlus Marion in Adelaide, South Australia. For inclusion, participants will be: 1) aged 60 years or older; 2) community dwelling; 3) live in the metropolitan area; 4) "insufficiently active", defined as doing less than 60 minutes per week of at least moderate intensity physical activity for at least the three previous months; 5) working less than two days per week in paid or voluntary employment; 6) be diagnosed with non-insulin dependent T2DM, and 7) have the ability to self-monitor glucose to calibrate the Continuous Glucose Monitoring System (CGMS) that will be used in this study.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they: 1) have a medical condition that inhibits standing; 2) have an unstable or life threatening medical condition; severe visual or hearing impairment; 3) are unable to commit to the assessment schedule; 4) are unable to understand written or spoken English; 5) are unable to walk independently; or 6) have a significant cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Efficacy
Statistical methods / analysis
In a single group pre-post study involving community-dwelling older adults, objectively measured daily sitting time was reduced by 52 minutes per day; representing an effect size of 0.58. To detect a similar effect size, with 80 per cent power and alpha of 0.05, a sample of 27 participants is required. To allow for attrition, 30 participants will be recruited into this study.

Demographic data will be descriptively analysed. Changes in objectively measured sedentary time, and self-reported use of time will be analysed using paired t tests, with sequential Bonferroni corrections to account for multiple comparisons. Cohen's d effect sizes will be calculated for all outcomes. Associations between activity levels and glucose excursion will be explored using Pearson’s correlation coefficient. Alpha will be set at 0.05 for all analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/01/2018
Date of last participant enrolment
Anticipated
16/10/2019
Actual
Date of last data collection
Anticipated
24/12/2019
Actual
Sample size
Target
30
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11496 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23520 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300220 0
University
Name [1] 300220 0
Flinders University
Country [1] 300220 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 299629 0
Individual
Name [1] 299629 0
Associate Professor Morton Burt
Address [1] 299629 0
Southern Adelaide Diabetes and Endocrine Service
GP Plus Marion
10 Milham Street
Oaklands Park
SA 5046
Country [1] 299629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301042 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301042 0
Ethics committee country [1] 301042 0
Australia
Date submitted for ethics approval [1] 301042 0
20/02/2017
Approval date [1] 301042 0
04/04/2017
Ethics approval number [1] 301042 0
35.17

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

Contacts
Principal investigator
Name 85682 0
Dr Lucy Lewis
Address 85682 0
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Country 85682 0
Australia
Phone 85682 0
+61 8 72218261
Fax 85682 0
Email 85682 0
lucy.lewis@flinders.edu.au
Contact person for public queries
Name 85683 0
Lucy Lewis
Address 85683 0
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Country 85683 0
Australia
Phone 85683 0
+61 8 72218261
Fax 85683 0
Email 85683 0
lucy.lewis@flinders.edu.au
Contact person for scientific queries
Name 85684 0
Lucy Lewis
Address 85684 0
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Country 85684 0
Australia
Phone 85684 0
+61 8 72218261
Fax 85684 0
Email 85684 0
lucy.lewis@flinders.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 does not allow for IPD 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.