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Trial registered on ANZCTR


Registration number
ACTRN12620001129976
Ethics application status
Approved
Date submitted
28/07/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Structured Weight Management Program for Diabetes REmission Clinical Trial-Australia – (DiRECT-Aus Study)
Scientific title
Efficacy of a Structured Weight Management Program for achieving Diabetes REmission in a primary care setting in Australia – Diabetes Remission Clinical Trial-Australia(DiRECT-Aus Study)
Secondary ID [1] 302132 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
DiRECT-Aus Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 316731 0
Obesity 318406 0
Overweight 318762 0
Condition category
Condition code
Metabolic and Endocrine 314987 314987 0 0
Diabetes
Diet and Nutrition 316419 316419 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention has three phases. Phase one is a 3400kJ (800kcal)/day Total Diet Replacement (TDR) using a commercial micronutrient-replete meal replacement product OPTIFAST, followed for 13 weeks. Phase two is a stepped food reintroduction during which meal replacement products will be replaced with low fat meals administered in three steps over 2-8 weeks. Starting at week 13, participants will replace one Optifast VLED product per day with one low fat meal (Step 1) which will be followed for a period of one to two weeks before replacing another Optifast VLED product with another low fat meal (Step 2) and again for Step 3. The timing of the Steps 1-3 of food reintroduction will determined by the participant and dietitian. Irrespective of the timing of Food Reintroduction, all participants will commence food reintroduction at Week 13 and remain on Step 3 of food Reintroduction until Week 21. Phase three is a weight maintenance diet during which participants will be provided with an individually tailored calorie prescription to support weight maintenance based on the Australian Guide to Healthy Eating with a target of <30% energy from fat and no more than 35% energy from fat. . These meal plans are intended to act as a guide and as participants become more confident and learn new skills they will be encouraged to self-manage. Diet goals will be discussed and agreed upon with the dietitian.
. Throughout the entire study participants will receive education on behavioural weight management through a structured program delivered by dietitians with experience in supporting behaviour change. Participants will meet with the dietitian every 2 weeks in the first 17 weeks of the study and then every month until week 52 and a new topic in behavioural weight management will be discussed at every visit supported by a participant workbook.
.
Throughout the entire 12 months of the study participants will also be supported to increase their physical activity levels. Participants are encouraged to include physical activity in line with the Australian Physical Activity Guidelines, including 150 minutes per week of moderate intensity physical activity, muscle strengthening activities on two days each week and limiting sitting time. As participants physical fitness improves, participants are encouraged to increase physical activity aiming for 10,000 – 15,000 steps/day. Modules on physical activity will be delivered within the behavioural weight management program at visits 3, 5, 8 and 18 and included in the participant workbook. Steps counts (on the participants mobile phone) will be used to track activity and increase motivation where available.

During the weight maintenance phase, rescue package will be offered to any participant who regains >2 kg or experience re-emergence of diabetes. For weight regain of 2-4 kg participant will be offered the use of Optifast to replace one main-meal per day for 4 weeks. For weight regain of >4kg or reemergence of diabetes, participants will be offered 4 weeks VLED with fortnightly practice nurse/dietitian review followed by a 2-4 week food re-introduction (add 1 meal/day/ week).

The Optifast meal replacements are free and at no cost to the participants.

Participants will continue to receive standard care under current clinical guidelines for T2DM. Intention to treat analysis will be conducted, with follow-up data continuing to be collected even if treatment is stopped.

The intervention will be delivered in primary care practices by practice nurses/dietitians (according to local availability and practice) with training, support and mentoring from the Diabetes NSW & ACT and The Boden Collaboration, University of Sydney.

The frequency and duration of study visits that participants will attend as part of the intervention'

Participants will attend a minimum of 20 visits, with additional visits possible for the delivery of rescue packages. Visits may take up to 60 minutes. All participants will return one week after screening for review, and then once every two weeks until week 17. After week 17, participants will attend once month, unless a rescue package is used. Visits 1,2,3,5,7,8,10,11, 12, 14,16,18,19 are intended to be performed as one on one sessions and visit 4,6,9,13,15,17,20 are intended to be performed as group sessions, with flexibility to facilitate safe and convenient delivery as per local conditions. Telephone visits with the dietitian may also be used where required, although participants will need to attend to have measurements taken as per the visit scheduled outlined above.
Intervention code [1] 317177 0
Treatment: Other
Intervention code [2] 318186 0
Lifestyle
Intervention code [3] 318187 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323291 0
Glycated haemoglobin (HbA1c) less than 6.5 percent (48mmol/mol) with no use of antihyperglycemic medication for at least 2 months
Timepoint [1] 323291 0
The primary timepoint: is measured at week 52
Secondary outcome [1] 381461 0
To evaluate the attitudes of participants to the very low energy diet (VLED) program (including acceptability, ease of use and perceived value) by completing the Food Acceptance Questionnaire

Timepoint [1] 381461 0
To measured at Baseline, Week 13, Week 25 and Week 52.
Secondary outcome [2] 386148 0
To evaluate the effect of the structured weight management program on the quality of life by completing the Quality of Life (EQ-5D) questionnaire.
Timepoint [2] 386148 0
To be measured at Baseline, Week 13, Week 25 and Week 5.
Secondary outcome [3] 386160 0
Physical Activity measured by the Baecke physical activity questionnaire and where available step count.
Timepoint [3] 386160 0
To be measured at Baseline, Week 13, Week 25 and Week 52.
Secondary outcome [4] 387192 0
Weight measurement
Timepoint [4] 387192 0
To be measured at Baseline, Week 13, Week 25, Week 37 and Week 52.
Secondary outcome [5] 387193 0
Waist circumference measurement
Timepoint [5] 387193 0
To be measured at Baseline, Week 13, Week 25, Week 37 and Week 52.
Secondary outcome [6] 387194 0
Blood pressure measurement via blood pressure monitor.
Timepoint [6] 387194 0
To be measured at Baseline and Week 52.
Secondary outcome [7] 387195 0
Capillary blood glucose is measured by a blood glucose meter.
Timepoint [7] 387195 0
To be measured at Baseline and Week 52.
Secondary outcome [8] 387196 0
Urea measurement via blood test.
Timepoint [8] 387196 0
To be measured at Baseline and Week 52
Secondary outcome [9] 387197 0
Electrolyte measurement via blood test.
Timepoint [9] 387197 0
To be measured at Baseline and Week 52.
Secondary outcome [10] 387198 0
Estimated glomerular filtration rate (eGFR) measurement via blood test (and calculated by the Modification of Diet and Renal Disease formula).
Timepoint [10] 387198 0
To be measured at Baseline and Week 52.
Secondary outcome [11] 387199 0
Liver Function tests (LFTs) via blood test
Timepoint [11] 387199 0
To be measured at Baseline and Week 52.
Secondary outcome [12] 387200 0
Lipid measurement via fasting blood test
Timepoint [12] 387200 0
To be measured at Baseline and Week 52.
Secondary outcome [13] 387201 0
Albuminuria measurement via blood test
Timepoint [13] 387201 0
To be measured at Baseline and Week 52.
Secondary outcome [14] 387204 0
How often do participants frequently and infrequently go to hospital?
Timepoint [14] 387204 0
Lumos linked data of patients at GP practices within NSW will be analysed by the investigator team in the NSW Ministry of Health in approximately the next 3 years.
Secondary outcome [15] 387205 0
Over an average 24-hour period, for participants attending the gp practice, when do potentially avoidable Emergency Department visits occur?
Timepoint [15] 387205 0
Lumos linked data of patients at GP practices within NSW will be analysed by the investigator team in the NSW Ministry of Health in approximately the next 3 years.
Secondary outcome [16] 387206 0
How many of participants had any combination of emergency department presentations, admissions to hospital or death?
Timepoint [16] 387206 0
Lumos linked data of patients at GP practices within NSW will be analysed by the investigator team in the NSW Ministry of Health in approximately the next 3 years.

Eligibility
Key inclusion criteria
• Men and women aged 20-65 years, all ethnicities
• T2DM of duration 0-6 years
• Body mass index (BMI)>27 kg/m2
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current insulin use
• HbA1c greater than 86 mmol/mol (10%) at screening
• Weight loss of greater than 5kg within the last 6 months
• Recent eGFR equals 45 ml/min/1.732
• Substance abuse
• Known cancer
• Myocardial infarction within previous 6 months
• Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA):
A. Grade 3 - marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and
B. Grade 4 - unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
• Learning difficulties
• Current treatment with anti-obesity drugs
• Diagnosed eating disorder or purging
• Pregnant/ considering pregnancy
• Patients with unstable mental illness
• People currently participating in another clinical research trial
• Allergy to Optifast or any of its ingredients

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
250 subjects to be recruited from 5 Primary Health Networks (PHNs) through 5 general practitioner (GP) practices per PHN (total 50 GP practices recruiting 10 subjects per practice).

Duration of Treatment: 12 months, with at least bi-annual follow up for 5 years (subject to additional funding)

Statistical Analysis: Data will be analysed primarily on an intention-to-treat (ITT) basis, using best available follow-up data for weight and diabetes status for subjects who discontinue the formal weight management program. Diet intolerance or poor-compliance will be recorded: these patients will be included in ITT analysis, but excluded in ‘completers analyses’.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/10/2020
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
250
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305298 0
Charities/Societies/Foundations
Name [1] 305298 0
Diabetes NSW & ACT
Country [1] 305298 0
Australia
Funding source category [2] 306557 0
Government body
Name [2] 306557 0
SNPHN Limited t/as SYDNEY NORTH HEALTH NETWORK
Country [2] 306557 0
Australia
Funding source category [3] 306558 0
Government body
Name [3] 306558 0
SWSPHN Limited t/as South Western Sydney Primary Health Network
Country [3] 306558 0
Australia
Funding source category [4] 306559 0
Government body
Name [4] 306559 0
WentWest Limited t/as Western Sydney Primary Health Network
Country [4] 306559 0
Australia
Funding source category [5] 306560 0
Government body
Name [5] 306560 0
Healthy North Coast Limited t/as North Coast Primary Health Network
Country [5] 306560 0
Australia
Funding source category [6] 306561 0
Government body
Name [6] 306561 0
Western Health Alliance Limited t/as Western NSW Primary Health Network
Country [6] 306561 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Diabetes NSW & ACT
Address
26 Arundel St, Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 307074 0
None
Name [1] 307074 0
Address [1] 307074 0
Country [1] 307074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305636 0
Sydney Local Health District Ethics Review Committee (RPAH Zone).
Ethics committee address [1] 305636 0
Ethics committee country [1] 305636 0
Australia
Date submitted for ethics approval [1] 305636 0
26/02/2020
Approval date [1] 305636 0
15/07/2020
Ethics approval number [1] 305636 0
X20-0060

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

Contacts
Principal investigator
Name 101042 0
Prof Stephen Colagiuri
Address 101042 0
The Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre, Building D17, Level 2, University of Sydney, Camperdown NSW 2050
Country 101042 0
Australia
Phone 101042 0
+61 2 86271914
Fax 101042 0
+61 2 86270141
Email 101042 0
stephen.colagiuri@sydney.edu.au
Contact person for public queries
Name 101043 0
Stephen Colagiuri
Address 101043 0
The Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre, Building D17, Level 2, University of Sydney, Campderdown NSW 2050
Country 101043 0
Australia
Phone 101043 0
+61 2 86271914
Fax 101043 0
+61 2 86270141
Email 101043 0
stephen.colagiuri@sydney.edu.au
Contact person for scientific queries
Name 101044 0
Stephen Colagiuri
Address 101044 0
The Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre, Building D17, Level 2, University of Sydney, Camperdown NSW 2050
Country 101044 0
Australia
Phone 101044 0
+61 2 86271914
Fax 101044 0
+61 2 86270141
Email 101044 0
stephen.colagiuri@sydney.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8926Study protocol  slhd-rpaethics@health.nsw.gov.au 379496-(Uploaded-25-08-2020-12-45-07)-Study-related document.pdf
8927Ethical approval  slhd-rpaethics@health.nsw.gov.au 379496-(Uploaded-25-08-2020-12-46-23)-Study-related document.pdf



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.