Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000650796
Ethics application status
Approved
Date submitted
16/02/2022
Date registered
3/05/2022
Date last updated
3/05/2022
Date data sharing statement initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes Remission in Aboriginal Women (The DRAW project): The Effect of Continuous Glucose Monitoring and Yarning on Type 2 Diabetes Mellitus (T2DM) in Aboriginal Women
Scientific title
Diabetes Remission in Aboriginal Women (The DRAW project): The Effect of Continuous Glucose Monitoring and Yarning on Type 2 Diabetes Mellitus (T2DM) in Aboriginal Women.
Secondary ID [1] 306439 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Diabetes Remission in Aboriginal Women (DRAW)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 325279 0
Condition category
Condition code
Metabolic and Endocrine 322679 322679 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Each participant will be orientated to and fitted with, a wearable Continuous Glucose Monitor (CGM) that has a lifespan of 3 months and which provides blood sugar level data to their existing device (phone or computer) and that of their GP and researcher. The CGM sensor is adhered by skin sensitive adhesive patch and can be removed safely and easily at any time by the patient if and when they choose including at the completion of the trial.
• Each participant will join with a group of up to 10-12 other participants
• Each group will attend a 90-minute Nyully cooking class, weekly for 7 weeks, and engage in learning to ‘de-colonise’ their diet as well as preparing and sharing a different meal each week. It is intended that the classes will be conducted face to face at the Health Service community kitchen. However, these sessions can be undertaken online if required. Records of attendance will be maintained by the research officer.
• Following the Nyully cooking session each group will engage a Medical Yarn Up (MYU). The MYU consists of a 20-minute (approx.) education session about their T2DM and a shared medical appointment consultation.
The education component of the MYU will be led by either an Aboriginal Health Practitioner and/or Diabetic Educator. One of 7 pre-recorded, co-designed, narrated powerpoint video presentations will be delivered covering a set of key points each session. Each of the videos is designed to encourage a facilitated discussion during and after the video delivery. The program of 7 video sessions is designed to cover a curriculum that includes: Understanding Diabetes, Weight management, Moving muscles for T2DM, Eating for the body, Eating for the mind, Managing stress, sleep and Other risk factors.

This presentation and the facilitated discussion will be immediately followed by a facilitated consultation with their General Practitioner in the manner of a shared medical appointment, with the group present and participating.

Attendance records will be maintained by the facilitator and medical records by the general practitioner.
Intervention code [1] 322883 0
Prevention
Intervention code [2] 322884 0
Lifestyle
Intervention code [3] 322885 0
Treatment: Devices
Comparator / control treatment
This trial does not have the power to justify a dedicated control group. Instead we intend to use participants who commence the trial but who are unable to complete it as an opportunistic comparator against those participants who complete the trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330491 0
HbA1c below 5.5% as measured from blood analysis.
Timepoint [1] 330491 0
The blood test for HbA1c will be collected pre-intervention and then again at 3, 6,and 12 months .after the pre-intervention sample.
Primary outcome [2] 330492 0
Participants' retention rates will be measured as a primary outcome through an audit of the attendance records that will be kept by the research officer.
Timepoint [2] 330492 0
Attendance records will be kept for the 7 sessions intended.
Secondary outcome [1] 406418 0
Body fat percentage. Body fat percentage data will be collected from each participant using Bioelectric Impedance (BIA) scales.
Timepoint [1] 406418 0
Body fat percentage data will be collected pre and post-intervention (7 weeks post- enrolment) and again at 3, 6 and 12 months after the pre-intervention recording.

Eligibility
Key inclusion criteria
Women over 18 years of age who identify as Aboriginal, with a HbA1c great than 6.5% for more than 12 months but less than 5 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Other health concerns that might be compromised by participating in the trial as assessed by the their Medical Practitioner.

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)
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
The data will be collected from an opportunistic recruitment from a known pool of potential participants. .

Quantitative analysis will use regression analyses with generalised estimating equation (GEE) adjustment for repeated observations of the same participants which will be used to estimate percentage changes in mean HbA1c (%) body fat percentage (%) over the study period. For each GEE model, a Poisson distribution, log-link function and independent working correlation matrix will be used.

.To conservatively account for change to follow-up, an additional analysis will be be performed estimating percentage change in HbA1c and body fat percentage from baseline to 12 months by substituting missing values with baseline observation carried forward (BOCF).

Another analysis will calculate the proportions of patients who achieve clinically important HbA1c (>5.4%) and body fat percentage changes (>5%) from baseline to 12 months both by using the observed data and more conservatively by assuming those with missing values at 12 months will not have achieved clinically important weight loss.

Qualitative data will be collected through focus group interviews, pre and post intervention and gain at 12 months post intervention.. Data will be audio recorded, transcribed and thematically analysed using constant comparative analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310786 0
Government body
Name [1] 310786 0
Indigenous Australians Health Program
Country [1] 310786 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Society of Lifestyle Medicine
Address
PO Box 226, Northcote, VIC, 3070, Australia
Country
Australia
Secondary sponsor category [1] 312025 0
Other
Name [1] 312025 0
Waminda Aborignal Womens Health Service
Address [1] 312025 0
122 Kinghorne St, Nowra NSW 2541
Country [1] 312025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310360 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [1] 310360 0
35 Harvey St, Little Bay NSW 2036
Ethics committee country [1] 310360 0
Australia
Date submitted for ethics approval [1] 310360 0
20/10/2021
Approval date [1] 310360 0
20/01/2022
Ethics approval number [1] 310360 0
1876/21

Summary
Brief summary
This project will aim to reverse T2DM in Aboriginal women with sustained HBA1c above 6.5% and prevent T2DM in Aboriginal women who are considered pre-diabetic with HBA1c between 5.6 and 6.4%. This will be achieved by co-designing culturally and scientifically responsive materials and information by and for Aboriginal women to be delivered by a GP, Aboriginal Health Worker and Diabetes Educator through a procedure called Medical Yarn Ups. The project will address trauma, eating and nutrition, physical activity and other lifestyle determinants of T2DM. Performance indicators will include: sustained reductions in HBA1c to below 5.5%.; development, testing, satisfaction with and adoption of culturally and scientifically responsive materials and procedures that can be used sustainably in practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117378 0
A/Prof John Stevens
Address 117378 0
Dr. John Stevens
Australasian Society of Lifestyle Medicine Limited
PO Box 226
NORTHCOTE VIC 3070
Country 117378 0
Australia
Phone 117378 0
+61 428288526
Fax 117378 0
Email 117378 0
john.stevens@scu.edu.au
Contact person for public queries
Name 117379 0
A/Prof John Stevens
Address 117379 0
Dr. John Stevens
Australasian Society of Lifestyle Medicine Limited
PO Box 226
NORTHCOTE VIC 3070
Country 117379 0
Australia
Phone 117379 0
+61 428288526
Fax 117379 0
Email 117379 0
john.stevens@scu.edu.au
Contact person for scientific queries
Name 117380 0
A/Prof John Stevens
Address 117380 0
Dr. John Stevens
Australasian Society of Lifestyle Medicine Limited
PO Box 226
NORTHCOTE VIC 3070
Country 117380 0
Australia
Phone 117380 0
+61 428288526
Fax 117380 0
Email 117380 0
john.stevens@scu.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
This trial data will be viewed as culturally sensitive and remain the property of the First Nations participants who have contributed it. It is possible that data which is de-identified may be shared, but the agreement has not been finalised yet with the participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15121Study protocol    383580-(Uploaded-16-02-2022-14-51-44)-Study-related document.pdf
15122Ethical approval    383580-(Uploaded-16-02-2022-14-53-26)-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.