Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001074482p
Ethics application status
Submitted, not yet approved
Date submitted
3/09/2025
Date registered
2/10/2025
Date last updated
2/10/2025
Date data sharing statement initially provided
2/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Pilot Study of the Diabetes Body Project for Australian Adolescents with Type 1 Diabetes: Addressing Disordered Eating in a Paediatric Diabetes Setting
Scientific title
Clinical Pilot Study of the Diabetes Body Project for Australian Adolescents with Type 1 Diabetes: Evaluating the efficacy, acceptability and feasibility of an early intervention program for disordered eating.
Secondary ID [1] 315177 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 338619 0
Disordered Eating 338620 0
Condition category
Condition code
Metabolic and Endocrine 334915 334915 0 0
Diabetes
Mental Health 334916 334916 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study is a single-site pilot study to be conducted at John Hunter Children’s Hospital (JHCH) Diabetes service.
Five health care professionals (diabetes dietitians, mental health dietitian and diabetes nurse educators) from JHCH will participate in 6 hours of Diabetes Body Project (BDP) facilitator training provided by the DBP team at Oslo University Hospital to enable delivery. Facilitator training will be conducted 6 weeks prior to anticipated commencement of the intervention. The DBP consists of 6, 1-hour virtual sessions, each group consists of 8 participants, led by 2 trained facilitators. The sessions will be delivered via Zoom and will occur once a week for 6 consecutive weeks. In these sessions, participants explore the negative effects of pursuing the thin ideal, benefits of insulin use and diabetes self-care. Caregivers will also attend a 1-hour virtual group session via Zoom, facilitated by the diabetes social worker and dietitian, focused on providing an overview of the DPB content and supporting a healthy relationship with food, body image and diabetes management during week 1 of the program. Facilitators will record attendance and adherence to tasks during each session.
Intervention code [1] 331798 0
Treatment: Other
Intervention code [2] 331799 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342546 0
Change in Disordered Eating symptoms
Timepoint [1] 342546 0
Baseline, 1 week, 3 months and 6 months post program completion
Primary outcome [2] 342547 0
Change in glucose Time in Range (%TIR)
Timepoint [2] 342547 0
Baseline, 3 months, 6 months post program completion
Primary outcome [3] 342548 0
Change in Body image
Timepoint [3] 342548 0
Baseline, 1 week, 3 months and 6 months post program completion
Secondary outcome [1] 451257 0
Change in diabetes distress
Timepoint [1] 451257 0
Baseline, 1 week, 3 months and 6 months post program completion
Secondary outcome [2] 451258 0
Change in body mass (BMI Z score)
Timepoint [2] 451258 0
Baseline, 3 months, 6 months post program completion
Secondary outcome [3] 451259 0
Participant uptake
Timepoint [3] 451259 0
Initial contact from eligible participants and at the end of the enrolment period.
Secondary outcome [4] 451260 0
Participant retention
Timepoint [4] 451260 0
Attendance marked at the end of each session (1-6)
Secondary outcome [5] 451261 0
Participant satisfaction
Timepoint [5] 451261 0
1-2 weeks post program completion
Secondary outcome [6] 452464 0
Change in HbA1c
Timepoint [6] 452464 0
Baseline, 3 months, 6 months post program completion
Secondary outcome [7] 452466 0
Parent / caregiver satisfaction
Timepoint [7] 452466 0
1-2 weeks post parent / caregiver session
Secondary outcome [8] 452467 0
Facilitator satisfaction
Timepoint [8] 452467 0
1-2 weeks post completion of the program

Eligibility
Key inclusion criteria
Female, aged 13-17, diagnosed with T1D more than 6 month, Internet access
Minimum age
13 Years
Maximum age
17 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically diagnosed ED, uncontrolled coeliac disease (determined by elevated TTGs)

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/10/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319749 0
Government body
Name [1] 319749 0
Hunter New England Local Health District
Country [1] 319749 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 322258 0
None
Name [1] 322258 0
Address [1] 322258 0
Country [1] 322258 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318301 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 318301 0
Ethics committee country [1] 318301 0
Australia
Date submitted for ethics approval [1] 318301 0
27/08/2025
Approval date [1] 318301 0
Ethics approval number [1] 318301 0

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

Contacts
Principal investigator
Name 143754 0
Dr Carmel Smart
Address 143754 0
John Hunter Children's Hospital, Lookout Road, New Lambton Heights, New South Wales, 2305
Country 143754 0
Australia
Phone 143754 0
+61 2 49855429
Fax 143754 0
Email 143754 0
[email protected]
Contact person for public queries
Name 143755 0
Carmel Smart
Address 143755 0
John Hunter Children's Hospital, Lookout Road, New Lambton Heights, New South Wales, 2305
Country 143755 0
Australia
Phone 143755 0
+61 2 49855429
Fax 143755 0
Email 143755 0
[email protected]
Contact person for scientific queries
Name 143756 0
Prof Bruce King
Address 143756 0
John Hunter Children's Hospital, Lookout Road, New Lambton Heights, New South Wales, 2305
Country 143756 0
Australia
Phone 143756 0
+61 2 49855429
Fax 143756 0
Email 143756 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.