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Trial registered on ANZCTR


Registration number
ACTRN12617001624370p
Ethics application status
Submitted, not yet approved
Date submitted
15/11/2017
Date registered
13/12/2017
Date last updated
13/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Community exercise and education to improve blood glucose control, physical health outcomes, and well-being for people living with type II diabetes.
Scientific title
Community exercise and education to improve blood glucose control, physical health outcomes, and well-being at one-year follow-up for people living with type II diabetes.
Secondary ID [1] 293203 0
New Zealand Health Research Council 17/233
Universal Trial Number (UTN)
U1111-1205-2071
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type II diabetes 305201 0
Condition category
Condition code
Metabolic and Endocrine 304515 304515 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type: exercise and education plus "usual care"
Materials: exercise and education
Who will deliver the intervention: Exercise delivered by a New Zealand registered physiotherapist with a long term conditions nurse in attendance, each with a minimum of two years’ experience. Education delivered by appropriate health professional.
Mode of delivery: face-to-face group delivery.
Number of times: personalised intervention delivered in two 90-minute sessions per week for 12 weeks. Sessions comprise 45mins of exercise, followed by 45mins of education on health-related topics. Each exercise session includes aerobic exercise warm-up (5mins), aerobic and resistance exercise circuit with focus on major muscle groups (30mins), flexibility exercises (5mins). The exercise degree of difficulty and intensity level is individually prescribed (taking into account comorbidities), based on accepted exercise prescription protocols. Each education session focuses on a topic to support self-management of diabetes, such as ‘food portions’ and ‘foot health’, conducted by an appropriate health professional (e.g. dietitian, podiatrist). A “txt-to-remind service” to facilitate adherence. Participants then join the continuation exercise classes (held twice weekly for 60mins) for a duration on one year. This class uses the same format as the exercise sessions as the 12-week programme, except for a slightly longer period i.e. 10 mins aerobic warm-up, 40 mins of aerobic and resistance circuit class and 5 mins or flexibility exercise. There are no education sessions in the continuation exercise classes.
Location: delivered in a community hall
The trial's Clinical Advisory Group (comprising a Physiotherapist, Nurse and Dietitian), will ensure fidelity with random visits and use of a checklist.
Intervention code [1] 299458 0
Treatment: Other
Intervention code [2] 299459 0
Rehabilitation
Intervention code [3] 299460 0
Behaviour
Comparator / control treatment
"Usual care" plus DESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND): a one day education program designed to support people living with type 2 diabetes. "Usual care" is the individualised care that the participant primary physician prescribes, which may or my not include education regarding diet and physical activity participation.
Control group
Active

Outcomes
Primary outcome [1] 303970 0
Glycated Haemoglobin (HbA1c) (blood glucose control)
Timepoint [1] 303970 0
Between-group differences in mean changes in mmol/mol from baseline to 12 months follow-up.
Primary outcome [2] 303971 0
Audit of Diabetes-Dependent Quality of Life (well-being)
Timepoint [2] 303971 0
Difference in group mean changes in total score from baseline to 12 months follow-up.
Secondary outcome [1] 340560 0
Six minute walk test
Timepoint [1] 340560 0
Between-group differences in mean changes in distance walked (m) from baseline to 12 months follow-up.
Secondary outcome [2] 340561 0
body weight assessed by study staff waist and hip circumference
Timepoint [2] 340561 0
Between-group differences in mean changes from baseline to 12 months follow-up
Secondary outcome [3] 340883 0
height - assessed by study staff
Timepoint [3] 340883 0
Between-group differences in mean changes from baseline to 12 months follow-up
Secondary outcome [4] 340884 0
waist circumference - assessed by study staff
Timepoint [4] 340884 0
Between-group differences in mean changes from baseline to 12 months follow-up
Secondary outcome [5] 340885 0
hip circumference - assessed by study staff
Timepoint [5] 340885 0
Between-group differences in mean changes from baseline to 12 months follow-up

Eligibility
Key inclusion criteria
Adults (age 35 years and over) with defined type II diabetes, who have GP clearance to exercise, and live in Dunedin and Invercargill (New Zealand).
Minimum age
35 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with comorbid conditions that prevent safe engagement in exercise and thus do not have GP clearance to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque sealed randomisation envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent administrator using centralised computer generated random number tables stratified by centre (Dunedin / Invercargill) with random block lengths will develop the randomisation allocations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
A two centre trial (Dunedin, Invercargill) with a nested process evaluation:
1. Two arm parallel group open-label superiority stratified randomised controlled trial investigating effectiveness and, if effective, cost-effectiveness at one year. Equal numbers will be randomised to the intervention (DCEP) and control (DESMOND) groups.
2. Embedded process evaluation.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be performed in accordance with modified intention to treat principles (based on group randomised to and using all available data) using Stata 15.0 and R 3.4.2 with two-sided p<0.05 considered significant. Linear mixed models will examine differences in changes over time between groups for continuous outcomes adjusting for baseline values and centre as fixed effects along with a group-time interaction and a random participant effect to accommodate the repeated measures with between-group differences in changes in HbA1c at 12 months being used to determine programme effectiveness. Baseline psychological factors will be investigated as being of interest as predictors of outcomes in themselves adjusting for intervention group. Standard model diagnostics will be performed including examining normality and homoscedasticity of residuals and linearity of associations involving continuous predictors. Where appropriate, transformations (most likely natural-logarithmic transformations of outcomes) and the addition of quadratic terms of continuous predictors will be investigated. As missing data is likely to include informative missingness, the robustness of conclusions will be investigated through scenarios involving modifying values from multiple imputation models in plausible ways.

To provide 80% power to detect between-group differences at any time using a two-sided test at the 0.05 level for HbA1c of 5mmol/mol45 (assuming SD 10mmol/mol and without making assumptions around correlations between repeated measures), n=64/group would be needed. A reduction in 5mmol/mol is commonly accepted as the minimal clinically important difference for HbA1c. Allowing for approximately 40% drop-out (given longer follow-up to prior observation study), n=220 will be recruited in total (control and interventional group) across the two centres. This would also allow detecting correlations between psychological factors and changes in outcomes of 0.25 for the cohort with 80% power using a two-sided test at the 0.05 level.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 9362 0
New Zealand
State/province [1] 9362 0
Otago and Southland

Funding & Sponsors
Funding source category [1] 297833 0
Government body
Name [1] 297833 0
Health Research Council of New Zealand
Address [1] 297833 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 297833 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56, Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 296870 0
None
Name [1] 296870 0
Address [1] 296870 0
Country [1] 296870 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298882 0
Health and Disability Ethics Committee
Ethics committee address [1] 298882 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298882 0
New Zealand
Date submitted for ethics approval [1] 298882 0
15/11/2017
Approval date [1] 298882 0
Ethics approval number [1] 298882 0

Summary
Brief summary
We know that exercise assists the management of diabetes but presently no specific advice is available as to how people can safely and confidently engage in exercise. The Community Exercise and education Programme (DCEP) is an inter-professional coordinated, patient centred, whanau-supported package of care for people living with type II diabetes. It was developed in Dunedin to specifically target Maori and Pacific people and those living in low socioeconomic areas. It combines twice weekly education with tailored exercise for 12 weeks, followed by an ongoing weekly maintenance exercise class. The aim of this exploratory randomised controlled trial is to investigate whether those taking part in DCEP have more control of their diabetes and have better health outcomes one year later than people who do not participate in it. We will also find out whether DCEP is cost effective and what is required to roll it out into other areas of New Zealand.
Trial website
http://www.otago.ac.nz/physio/otago086432.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78546 0
Prof Leigh Hale
Address 78546 0
School of Physiotherapy, University of Otago
PO Box 56
Dunedin
9054
Country 78546 0
New Zealand
Phone 78546 0
+64 3 479 5425
Fax 78546 0
+64 3 479 8414
Email 78546 0
leigh.hale@otago.ac.nz
Contact person for public queries
Name 78547 0
Ms Bonnie Scarth
Address 78547 0
School of Physiotherapy, University of Otago
PO Box 56
Dunedin
9054
Country 78547 0
New Zealand
Phone 78547 0
+64 3 479 7130
Fax 78547 0
+64 3 479 8414
Email 78547 0
bonnie.scarth@otago.ac.nz
Contact person for scientific queries
Name 78548 0
Prof Leigh Hale
Address 78548 0
School of Physiotherapy, University of Otago
PO Box 56
Dunedin
9054
Country 78548 0
New Zealand
Phone 78548 0
+64 3 3 479 5425
Fax 78548 0
+64 3 479 8414
Email 78548 0
leigh.hale@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results