Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000555550
Ethics application status
Approved
Date submitted
11/04/2024
Date registered
2/05/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
2/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Novel Eating Disorder Prevention Program (Australian Diabetes Body Project) for Young Women with Type 1 Diabetes in a Clinic Setting: A Randomized Controlled Trial.
Scientific title
Evaluation of a Novel Eating Disorder Prevention Program (Australian Diabetes Body Project) for Young Women with Type 1 Diabetes in a Clinic Setting: A Randomized Controlled Trial.
Secondary ID [1] 311942 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Type 1 333532 0
Eating disorders 333533 0
Condition category
Condition code
Metabolic and Endocrine 330214 330214 0 0
Diabetes
Mental Health 330215 330215 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Australian Diabetes Body Project (ADBP) is a virtual, group-oriented, co-led (clinician and peer) ED prevention program based on cognitive dissonance theory.
The ADBP will involve six, one-hour, virtual sessions held over six consecutive weeks.
The group sessions will have two facilitators; a clinician (psychologist) and a peer-educator with T1D. Groups will include up to 8 participants, and will be held at various times throughout the year. In between the sessions, participants will complete homework exercises to be discussed at the following session.The topics for the six sessions are as follows:
1. Define the ideal and explore its origin
2. Examine the costs of pursuing this ideal
3. Explore ways to resist pressures to be thin
4. Discuss how to challenge our personal body image concerns
5. Learn new ways to talk more positively about our bodies.
6. Discuss how to promote a positive relationship with diabetes and insulin.
Adherence to the group sessions will be monitored by the group facilitators. Participants who fail to attend group sessions will be followed up by a facilitator or research team member.
Intervention code [1] 328399 0
Prevention
Intervention code [2] 328486 0
Lifestyle
Comparator / control treatment
The active control group will watch educational videos relating to diabetes management for the same amount of time as the intervention participants engage in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 337966 0
Body Dissatisfaction
Timepoint [1] 337966 0
Measured at baseline, post-intervention (six weeks), three months follow-up. The primary time-point for analysis will be three months.
Primary outcome [2] 337967 0
Eating disorder symptoms
Timepoint [2] 337967 0
Measured at baseline, post-intervention (six weeks), three months follow-up. The primary time-point for analysis will be three months.
Secondary outcome [1] 433916 0
Diabetes distress
Timepoint [1] 433916 0
Measured at baseline, post-intervention (six weeks), three months follow-up.
Secondary outcome [2] 433917 0
Anxiety and depression symptoms will be measured as a composite secondary outcome.
Timepoint [2] 433917 0
Measured at baseline, post-intervention (six weeks), three months follow-up.
Secondary outcome [3] 433918 0
Health-related quality of life
Timepoint [3] 433918 0
Measured at baseline, post-intervention (six weeks), three months follow-up.
Secondary outcome [4] 433919 0
Diabetes management
Timepoint [4] 433919 0
Measured at baseline, post-intervention (six weeks), three months follow-up.

Eligibility
Key inclusion criteria
1) Female
2) Age 15-25
3) Greater than 6 months post diagnosis of T1D
4) Administering insulin
5) Without ED-related hospitalisations in the prior 12 months
6) Answered “yes” to the question “do you have any body image concerns?”
7) Able to read and write English to a proficient level (that would impair their ability to complete online surveys).
8) Able to provide informed consent (those under 18 years of age must agree to participate, and also have a parent or guardian who will provide informed consent).
Minimum age
15 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Established ED who are medically unstable (requiring hospital admissions in the preceding 12 months according to medical records and the young person’s self-report)
2) Rapid weight loss (>1kg/week over several weeks)
3) Body Mass Index (BMI) less than 14kg/m2.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned 1:1 to the virtual ADBP or the active control group (educational videos) via a random number sequence provided by an independent statistician. Random permuted block randomisation with variable block sizes will be used to minimise chances of imbalance while maintaining unpredictability in the assignment sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
26/09/2024
Date of last participant enrolment
Anticipated
15/01/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
60
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26390 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 42365 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 316081 0
Other Collaborative groups
Name [1] 316081 0
Mater Research: Betty McGrath Seeding Grant
Country [1] 316081 0
Australia
Primary sponsor type
Hospital
Name
Mater Hospital
Address
Country
Australia
Secondary sponsor category [1] 318248 0
None
Name [1] 318248 0
Address [1] 318248 0
Country [1] 318248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314902 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 314902 0
Ethics committee country [1] 314902 0
Australia
Date submitted for ethics approval [1] 314902 0
04/03/2024
Approval date [1] 314902 0
08/04/2024
Ethics approval number [1] 314902 0
106039

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

Contacts
Principal investigator
Name 133098 0
Dr Neisha D'Silva
Address 133098 0
Queensland Diabetes Centre, Mater Health Services, Raymond Terrace, South Brisbane QLD 4101
Country 133098 0
Australia
Phone 133098 0
+61 7 31632500
Fax 133098 0
Email 133098 0
Neisha.D'[email protected]
Contact person for public queries
Name 133099 0
Neisha D'Silva
Address 133099 0
Queensland Diabetes Centre, Mater Health Services, Raymond Terrace, South Brisbane QLD 4101
Country 133099 0
Australia
Phone 133099 0
+61 7 31632500
Fax 133099 0
Email 133099 0
Neisha.D'[email protected]
Contact person for scientific queries
Name 133100 0
Neisha D'Silva
Address 133100 0
Queensland Diabetes Centre, Mater Health Services, Raymond Terrace, South Brisbane QLD 4101
Country 133100 0
Australia
Phone 133100 0
+61 7 31632500
Fax 133100 0
Email 133100 0
Neisha.D'[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to privacy constraints and the young age of participants, only aggregate data will be made available upon request.


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.