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Trial registered on ANZCTR


Registration number
ACTRN12620000027910
Ethics application status
Approved
Date submitted
10/12/2019
Date registered
17/01/2020
Date last updated
17/01/2020
Date data sharing statement initially provided
17/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Stepping up’ exercise for type 2 diabetes: a stepped care approach to lifestyle therapy
Scientific title
In patients with type 2 diabetes, is a stepped care approach more effective than control group to achieve a clinically meaningful improvement in weight loss and glucose levels.
Secondary ID [1] 300016 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 315509 0
Obesity 315554 0
Condition category
Condition code
Metabolic and Endocrine 313793 313793 0 0
Diabetes
Metabolic and Endocrine 313843 313843 0 0
Other metabolic disorders
Physical Medicine / Rehabilitation 313919 313919 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multi-site study conducted at The University of Queensland (primary site) and The University of Sydney (secondary site). The study is a randomised controlled trial employing Stepped Care intervention vs a Comparator. In a Stepped Care intervention, participants who do not meet a pre-determined therapeutic target are 'stepped up' to the next level of intervention. Participants who meet the pre-determined therapeutic targets maintain that level of intervention.

Stepped Care: All participants in the Stepped Care group start on a ‘low burden/low time commitment’ exercise prescription (150 minutes of home-based moderate-vigorous intensity aerobic exercise of their preferred choice per week (e.g. walking, treadmill, cycling, swimming- including community group-based or gymnasium based facilities if preferred) plus 2 days a week of home based resistance training-i.e the minimum physical activity guidelines for health). Those who meet these therapeutic targets (reductions of at least 0.4% in HbA1c and or a 3% weight loss) will continue at the prescription that has elicited a response- i.e., they will maintain that exercise prescription from the end of that particular step through to the 6 month follow up period. ‘Non-responders’ will be ‘stepped up’ to higher levels of exercise prescriptions.

The second step involves 300 min of home-based moderate-vigorous aerobic exercise per week plus 2 days of home based resistance training. Those who meet these therapeutic targets (reductions of at least 0.4% in HbA1c and or a 3% weight loss) will continue at the prescription in this step as above while those who still do not meet these targets will be ‘stepped up’ again.

The third and final step 3 will be the same as step 2, but will also include High Intensity Interval Training (HIIT). The HIIT protocol will consist of: warm-up for 5 min and at 60% of maximal heart rate (HRmax) followed by 4 x 4 min intervals at 85-95% HRmax interspersed with 3 min ‘recovery’ periods at 60% HRmax, then a 5 min cool down, 3 days a week, with one session a week supervised by an Exercise Specialist. Sessions will be generally conducted one-on-one with a maximum of 3 participants training at one time. All supervised sessions will be recorded on a clinical resource form and all home-based sessions will be recorded in an exercise log. Participants will be given a heart rate monitor and taught how to monitor the intensity of their exercise sessions using heart rates and ratings of perceived exertion (RPE). All supervised exercise will be conducted on a treadmill, unless orthopaedic limitation exists in which a cycle ergometer will be used. Home-based exercise depend on the access to exercise equipment and preferences of the individual participant. Accordingly, Step 3 will equal 105 min of HIIT, plus 195 min of moderate-vigorous home-based aerobic exercise, plus 2 resistance based sessions each week.

At each step, the frequency and duration of exercise sessions will be determined by the participant at the exercise prescription session (i.e. the participant will decide how they will meet the relevant Step’s exercise prescription targets). All participants in the Stepped Care group also receive dietary advice to follow a Mediterranean Diet Eating Pattern.

Support: All exercise prescription sessions will be with an Exercise Specialist. Individuals will have a total of 8 contacts with an Exercise Specialist: i) 2 x 30 minute face-to-face consultations in weeks 1 and 5 of a 8 week step, involving personalised exercise prescription and instruction on how to use an activity diary and activity monitor and ii) fortnightly contact with the Exercise Specialist. The resistance training program will be supported by provision of an exercise booklet illustrating and instructing the following exercises: Sit to stand (bodyweight), overhead press (using water bottles/cans of food as weight), squat (bodyweight), chest press/push up (body weight), lunge (bodyweight), arm curl (using water bottles/cans of food as weight), hip extension (body weight), triceps dips (body weight), calf raise (body weight), prone bridge (body weight). Progressions of these exercises will be facilitated by the exercise specialist.

In week 1, all participants will receive a 45 min individualised consultation with an Accredited Practicing Dietitian (APD). For the remainder of the intervention period (i.e. for either 8 wks, 16 wks or 24 wks depending on Step at which participants respond) monthly group-based 30 min check-ins, led by an accredited health profession via Zoom, will be offered to all participants to support adherence to the Mediterranean dietary pattern. All dietary information and contact with the APD will be consistent across participants.

Adherence to the home-based exercise programs will be monitored by: wearable activity monitor, an exercise diary and self-report to the exercise specialist at the face to face and telephone contact sessions. Adherence to the diet will be monitored by questionnaires at each assessment timepoint and by self report at the monthly group-based diet check-ins.

Outcome Assessment Time frames: Stepped Care participants will have measures at baseline, week 8; and then potentially at week 16; and potentially at week 24, pending their ‘response’. Stepped Care participants will have a follow up assessment 6 months after their post-assessment for the Step that they complete the study on.
Intervention code [1] 316286 0
Lifestyle
Intervention code [2] 316287 0
Treatment: Other
Intervention code [3] 316377 0
Behaviour
Comparator / control treatment
Participants randomised to the comparator group receive i) advice from an exercise specialist to meet the physical activity guidelines (including a home-based resistance training booklet, designed specifically for this study) in one 30 min face to face session, ii) a heart rate activity monitor as per the intervention group and iii) the same dietary advice and level of interaction with study personnel to follow a Mediterranean Diet Eating Pattern.
For participants in the Comparator group, outcomes will be measured at baseline, week 8, week 16, week 24 and at 6 months follow up.
Control group
Active

Outcomes
Primary outcome [1] 322201 0
Change in glycated haemoglobin (HbA1c): will be measured by a venous blood sample, with analysis conducted by a NATA approved commercial laboratory.

Pre-determined therapeutic target to determine 'response' = greater than or equal to 0.4% reduction in HbA1c
Timepoint [1] 322201 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months). Specific to this study design and our study aims and hypotheses, there is no 'primary endpoint'.
Primary outcome [2] 322235 0
Change in Body Mass

Pre-determined therapeutic target to determine 'response' = greater than or equal to 3% reduction in body mass
Timepoint [2] 322235 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months). Specific to this study design and our study aims and hypotheses, there is no 'primary endpoint'.
Secondary outcome [1] 377684 0
Feasibility- aligning with some dimensions of the ‘RE-AIM’ model:
1. Reach: will be determined by: i. rate of exclusions (from study specific screening survey), ii. participation rate among eligible individuals (from study specific screening survey), iii. reasons for refusal to participate (from study specific screening survey, only if participants volunteer their reason- they are not required to do so), iv. representativeness of participants of the target population (from study specific screening survey), v. clinical features of responders/non-responders/non-adherers (from baseline data collection), and vi. attrition (from study records of participant flow).
Timepoint [1] 377684 0
Baseline, Week 8, Week 16, Week 24, 6 months (where relevant for specific aspects of feasibility)
Secondary outcome [2] 377685 0
Safety (number and magnitude of adverse events). Assessed by monitoring of adverse events by a questionnaire specific to this study. Participants will be systematically asked at each assessment point to report on pre-determined physical symptoms, musculoskeletal injuries, acute illnesses, and health care utilisation.
Timepoint [2] 377685 0
Safety data will be collected on an ongoing basis, with specific questions asked at Baseline, Week 8, Week 16, Week 24, 6 months.
Secondary outcome [3] 377686 0
Change in Advance Glycated End Products (AGEs): will be assessed by placing the participants forearm on an AGE reader for 12 seconds.
Timepoint [3] 377686 0
Baseline, Week 8, Week 16, Week 24, 6 months
Secondary outcome [4] 377687 0
Waist circumference, measured in triplicate using the criteria described by the International Diabetes Federation. This will be measured using a standard flexible metallic tape measure.
Timepoint [4] 377687 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [5] 377688 0
Change in cardiorespiratory fitness (VO2peak, assessed via expired air gas analysis during an exercise stress test). The study protocol has been designed specifically for this study and is based on pre-determined preferred walking speed and an increase in treadmill grade at pre-defined time points.
Timepoint [5] 377688 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [6] 377689 0
Health related quality of life (QoL): assessed via the 36-item Short Form Survey (SF-36)
Timepoint [6] 377689 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [7] 377690 0
Vascular structure and function via brachial artery reactivity using Doppler ultrasound
Timepoint [7] 377690 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [8] 377691 0
Brain Blood flow using transcranial doppler ultrasound
Timepoint [8] 377691 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [9] 377693 0
Traditional CVD risk factors:
a) smoking status: will be determined via health history questionnaire
b) blood lipids and lipoproteins, fasting glucose and fasting insulin: blood samples will be taken after an overnight fast (= 8h),
c) diabetes history: will be determined via health history questionnaire.
d) systolic and diastolic blood pressure (mmHg, in triplicate): Blood pressure will be taken with a manual cuff after 10-15 minutes of quiet, relaxed sitting.
e) Body Mass Index (BMI)

The Framingham risk score will be calculated to evaluate the estimation of 10 year CVD risk at each time point.
Timepoint [9] 377693 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [10] 377694 0
Physical activity levels including sedentary behaviour: will be quantified via a composite of i) an Actigraph accelerometer, worn for 7 consecutive days (to quantify time spent in sedentary behaviour, time spent in light, moderate and vigorous physical activity) and ii) the Long Form International Physical Activity Questionnaire (IPAQ, to quantify time spent in moderate and vigorous activity in four domains: job-related, transport-related, home-related and leisure-related, and time spent sitting).
Timepoint [10] 377694 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [11] 377695 0
Levels of adherence to exercise prescription: defined as meeting at least 70% of exercise sessions and prescription targets. This will be determined by objectively quantified physical activity data from the activity monitors that participants will be given as part of the study. This will also be verified by self-reported activity levels at each face to face and telephone contact by the exercise specialist (self-reported physical activity information will be collected on a form designed specifically for this study). For Step 3, weekly session attendance will also be recorded.
Timepoint [11] 377695 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [12] 377696 0
Proportions of people who ‘respond’, ‘do not respond’ and ‘non-adherers’ to each step.
This will be determined mathematically by the total number of participants who start each step and who meet, and do not meet, the pre-defined therapeutic response criteria. Non-adherers will be determined as per descriptions in Secondary Outcome field #11.
Timepoint [12] 377696 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [13] 377697 0
Participant Experience: via qualitative evaluation exploring participant experience to the stepped approach and barriers and enablers to exercise adherence. These data will be collected by either a focus group or an individual interviews at the end of the the 6-month maintenance period. Participants who withdraw from the study will be invited to also undertake the focus group or an interview to capture their experiences. These focus groups/interviews will be audio recorded and transcribed verbatim by a trained researcher, with any identifying names removed from transcription, and the audio file will then be deleted.
Timepoint [13] 377697 0
At 6 months.
Secondary outcome [14] 377698 0
Maintenance: will be determined as the long-term adherence to each step.
This will be determined by objectively quantified physical activity data from the activity monitors that participants will be given as part of the study.. This will further be verified by actigraph activity monitoring and the IPAQ questionnaire.
Timepoint [14] 377698 0
At 6 months follow up
Secondary outcome [15] 377701 0
Diet quality: The 14-point Mediterranean diet Adherence Screener (MEDAS), generated for the PREDIMED study, will be used at each assessment point. This scoring tool has been validated against FFQ-derived scoring where a higher MEDAS score was associated with decreased 10-year estimated CHD risk in the Spanish PREDIMED cohort
Timepoint [15] 377701 0
Baseline, Week 8, Week 16, Week 24, 6 months
Secondary outcome [16] 378074 0
Body fat- a composite of total body and regional fat % will be measured via dual-energy X-ray absorptiometry as per manufacturer instructions.
Timepoint [16] 378074 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [17] 378075 0
Liver fat will be assessed as intrahepatic lipid via magnetic resonance spectroscopy (1H-MRS)
Timepoint [17] 378075 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [18] 378076 0
Aortic stiffness via pulse wave velocity using SphygmoCor
Timepoint [18] 378076 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [19] 378077 0
Central blood pressures using SpygmoCor
Timepoint [19] 378077 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [20] 378251 0
Health related quality of life (QoL): assessed via the World Health Organization Quality of Life (WHOQOL)
Timepoint [20] 378251 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [21] 378252 0
Renal sinus fat will be assessed via magnetic resonance imaging (MRI)
Timepoint [21] 378252 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [22] 378253 0
Abdominal adipose tissue (a composite of visceral and abdominal subcutaneous adipose tissue) via magnetic resonance imaging (MRI)
Timepoint [22] 378253 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).
Secondary outcome [23] 378888 0
Lean body mass will be measured via dual-energy X-ray absorptiometry as per manufacturer instructions.
Timepoint [23] 378888 0
All participants will be assessed at baseline, Week 8 and 6 months.
Participants in Stepped Care who are 'stepped up' to Step 2 will also be assessed at Week 16.
Participants in Stepped Care who are 'stepped up' to Step 3 will also be assessed at Week 24.
Participants in the comparator group will be assessed at all timepoints (Baseline, Week 8, Week 16, Week 24, 6 months).

Eligibility
Key inclusion criteria
Confirmed T2D (HbA1 c greater than or equal to 6.5%) and central obesity (waist circumference greater than or equal to 80cm for women and greater than or equal to 94cm for men).
Minimum age
25 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active individuals (i.e. meeting current activity guidelines), participants for whom a physician deems that exercise is contraindicated, unstable coronary artery disease, myocardial infarction within 6 months, uncontrolled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >90mmHg), uncontrolled cardiac or metabolic disease, alcoholic liver disease, viral hepatitis, cirrhosis, significant neurological, cognitive, back or lower limb impairment, significant musculoskeletal conditions, on insulin therapy or recent change in hypoglycaemic medication (past 3 months), pregnancy.

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)
Group allocation will be concealed in sealed opaque envelopes, managed by an investigator not directly involved in assessment or training of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a web-based process concealing the randomisation procedure. Where possible, project staff conducting the assessments will be blinded to participants’ allocation. Participants will be randomised in 2:1 ratio into Stepped Care Comparator. PI Keating will be responsible for randomisation from a central site (UQ).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The primary analysis will aim to examine the overall difference between the proportion of individuals in the Stepped Care and the Comparator who achieve the target health outcomes (that is greater than or equal to 3% weight loss and/or HbA1c greater than or equal to -0.4%). Chi-square (or Fisher’s Exact test where appropriate) tests will be used to examine the difference between Stepped Care and Control groups when outcome will be treated as a binary variable (yes/no).
The secondary analysis will aim to examine the overall difference between the proportion of individuals in the Stepped Care and the Comparator at follow up (6 months) and at each step in the Stepped Care intervention. The magnitude of change in body mass and HbA1c will also be quantified as a continuous variable.

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 in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 304469 0
Government body
Name [1] 304469 0
NHMRC Early Career Fellowship
Address [1] 304469 0
GPO Box 1421
Canberra ACT 2601
Country [1] 304469 0
Australia
Funding source category [2] 304500 0
Other
Name [2] 304500 0
PI Keating Consultancy Account
Address [2] 304500 0
Shelley Keating
School of Human Movement and Nutrition Sciences
University of Queensland
St Lucia, QLD
4072
Country [2] 304500 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 304740 0
None
Name [1] 304740 0
Address [1] 304740 0
Country [1] 304740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304902 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 304902 0
Office of Research Ethics
The University of Queensland
St Lucia, Qld
4072 Australia
Ethics committee country [1] 304902 0
Australia
Date submitted for ethics approval [1] 304902 0
15/10/2019
Approval date [1] 304902 0
09/12/2019
Ethics approval number [1] 304902 0
2019002514

Summary
Brief summary
Obesity-related type 2 diabetes (T2D) is increasing in prevalence in Australia and globally, We have shown that there is considerable inter-individual variability in weight loss and glucose benefit in response to a given dose of exercise in adults with obesity, Therefore, the ‘one-size-fits-all’ approach to exercise prescription, which is the basis of current exercise recommendations for obesity-related disease management, is inadequate.
This study will employ a ‘Stepped Care’ methodology to meet the need for tailored, individualised strategies for the management of obesity and related conditions.

Participants will be randomised into either the Stepped Care arm or a Comparator group (n=80, randomised in 2:1 ratio for Stepped Care: Comparator). All participants in the Stepped Care arm commence on the ‘lowest dose’ prescription, which is incrementally increased based on individual response as defined by predetermined clinical targets.
Step 1: = 150 minutes of moderate to vigorous exercise per week;
Step 2: = 300 minutes of moderate to vigorous exercise per week;
Step 3: = 300 minutes of moderate to vigorous exercise per week including 3 sessions/week of high intensity interval training (HIIT) (4 x 4 min at 85-95% maximal heart rate, interspersed with 3 min recovery bouts at 60-65% maximal heart rate, 3 days/week, with one session/week supervised).
The primary AIM of this study is to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes (that is, = 3% weight loss and/or HbA1c = -0.4%) in the Stepped Care and the Comparator groups.
The secondary AIMs of this study are to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes in the Stepped Care and the Comparator at i) follow up (6 months), and ii) at each step in the Stepped Care intervention, and iii) determine the magnitude of change in body mass and HbA1c between the Stepped Care and the Comparator groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98590 0
Dr Shelley Keating
Address 98590 0
Centre for Research on Exercise, Physical Activity and Heath (CRExPAH)
School of Human Movement and Nutrition Sciences
The University of Queensland
HMS Building (26B)
St Lucia, 4072
Queensland
Country 98590 0
Australia
Phone 98590 0
+61 733469999
Fax 98590 0
Email 98590 0
s.keating@uq.edu.au
Contact person for public queries
Name 98591 0
Dr Shelley Keating
Address 98591 0
Centre for Research on Exercise, Physical Activity and Heath (CRExPAH)
School of Human Movement and Nutrition Sciences
The University of Queensland
HMS Building (26B)
St Lucia, 4072
Queensland
Country 98591 0
Australia
Phone 98591 0
+61 733469999
Fax 98591 0
Email 98591 0
s.keating@uq.edu.au
Contact person for scientific queries
Name 98592 0
Dr Shelley Keating
Address 98592 0
Centre for Research on Exercise, Physical Activity and Heath (CRExPAH)
School of Human Movement and Nutrition Sciences
The University of Queensland
HMS Building (26B)
St Lucia, 4072
Queensland
Country 98592 0
Australia
Phone 98592 0
+61 733469999
Fax 98592 0
Email 98592 0
s.keating@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For data transparency, de-identified meta-data will be available on an open repository (UQ) and available upon request. Individual participant data of published results only will be shared.
When will data be available (start and end dates)?
After the publication of results with no end date determined.
Available to whom?
To staff of UQ or other researchers upon request
Available for what types of analyses?
Verification of results
How or where can data be obtained?
UQ ePortal and available to others upon request via email to Principal Investigator Dr Shelley Keating s.keating@uq.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results