Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000228381
Ethics application status
Approved
Date submitted
6/02/2017
Date registered
13/02/2017
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
ANDY Diabetes Trial: Addressing Non-adherence to Diet in Young people with Diabetes
Scientific title
Imagery Training to Promote Healthy Eating and Glycemic Control for Adolescents with Diabetes: Trial of a Robotic Intervention
Secondary ID [1] 291038 0
None
Universal Trial Number (UTN)
Trial acronym
ANDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 301829 0
Condition category
Condition code
Metabolic and Endocrine 301507 301507 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is an uncontrolled pilot. Main assessments occur at baseline, week 4 and week 8. Minor assessments occur at week 1, week 2 and week 3. The assessment materials include a Snack Intake Index, Snack TLFB, modified Snack-OTI, assessment of motivation to change behaviour, confidence to control snack intake scale and robot opinion questions. Different combinations of these measures are presented at different assessment time points. Demographic data and treatment expectancy are collected at the baseline assessment. The intervention will be delivered by a social robot (NAO robot), which has been programmed to deliver the intervention designed by three clinical research professors with extensive clinical health behaviour experience. The intervention will involve two face-to-face sessions (2 x 60 minute sessions) delivered by the robot in South Brisbane and two pre-recorded online video sessions (2 x 10 minute sessions) delivered by the robot as a booster treatment session with all sessions provided individually. A semi-structured qualitative interview will be conducted at the end of the second face-to-face session. The two face-to-face sessions are provided within two weeks, and two video sessions sent before and after the second face-to-face sessions. The social robot will deliver a modified and static version of Functional Imagery Training (Motivational interviewing with an imagery-based review of motivation, including imagery-based exercises for building motivation towards change. The intervention content will mostly be static and pre-programmed, with limited branching and customization. Fidelity of the script to key components of Functional Imagery Training has been checked by the developers of that intervention
Intervention code [1] 297011 0
Behaviour
Intervention code [2] 297096 0
Treatment: Devices
Comparator / control treatment
There is no comparator or control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300900 0
Self-reported number of occasions with high-sugar snack or drink consumption per week
Timepoint [1] 300900 0
4 weeks post-baseline (relative to Baseline)
Primary outcome [2] 300990 0
Self-reported motivation to reduce high-sugar snack or drink consumption
Timepoint [2] 300990 0
4 weeks post-baseline (relative to Baseline)
Primary outcome [3] 300991 0
Confidence in being able to control high-sugar snack or drink consumption using a questionnaire designed by trial members.
Timepoint [3] 300991 0
4 weeks post-baseline (relative to Baseline)
Secondary outcome [1] 331296 0
HbA1c test data collected by the hospital staff during their clinic appointment
Timepoint [1] 331296 0
Baseline, Week 12

Eligibility
Key inclusion criteria
Participants will be insulin-dependent with type 1 diabetes for at least 1 year who are patients of Lady Cilento Children's Hospital Children’s Diabetes Service in Brisbane, who had at least 3 inter-meal periods in the previous 6 weeks where deviated from dietary/insulin regimen
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to speak and read English, serious cognitive impairment, severe behavioural or emotional misconduct; diagnosed with an eating disorder

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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/05/2017
Actual
8/06/2017
Date of last participant enrolment
Anticipated
1/06/2017
Actual
31/07/2017
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
90
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7399 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 15197 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 295522 0
Government body
Name [1] 295522 0
Australian Government Department of Education and Training
Country [1] 295522 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street; Brisbane, QLD, 4000, Australia
Country
Australia
Secondary sponsor category [1] 294342 0
None
Name [1] 294342 0
Address [1] 294342 0
Country [1] 294342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296797 0
Children's Health Queensland
Ethics committee address [1] 296797 0
Ethics committee country [1] 296797 0
Australia
Date submitted for ethics approval [1] 296797 0
24/04/2016
Approval date [1] 296797 0
06/06/2016
Ethics approval number [1] 296797 0
HREC/16/QRCH/100

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

Contacts
Principal investigator
Name 71014 0
Ms Nicole Robinson
Address 71014 0
Queensland University of Technology and Centre for Children's Health Research, 62 Raymond Terrace, South Brisbane, QLD, 4101
Country 71014 0
Australia
Phone 71014 0
+61 (0) 7 3069 7533
Fax 71014 0
Email 71014 0
nicole.robinson@hdr.qut.edu.au
Contact person for public queries
Name 71015 0
Nicole Robinson
Address 71015 0
Queensland University of Technology and Centre for Children's Health Research, 62 Raymond Terrace, South Brisbane, QLD, 4101
Country 71015 0
Australia
Phone 71015 0
+61 (0) 7 3069 7533
Fax 71015 0
Email 71015 0
nicole.robinson@hdr.qut.edu.au
Contact person for scientific queries
Name 71016 0
David Kavanagh
Address 71016 0
Queensland University of Technology and Centre for Children's Health Research, 62 Raymond Terrace, South Brisbane, QLD, 4101
Country 71016 0
Australia
Phone 71016 0
+61 (0) 7 3069 7327
Fax 71016 0
Email 71016 0
david.kavanagh@qut.edu.au

No information has been provided regarding IPD availability


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.