Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001257257
Ethics application status
Approved
Date submitted
23/07/2018
Date registered
25/07/2018
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Hunger Training the answer to reducing the risk of Diabetes? A pilot study
Scientific title
Is Hunger Training the answer to reducing the risk of Diabetes? A pilot study
Secondary ID [1] 295578 0
Nil known
Universal Trial Number (UTN)
U1111-1213-2219
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 308862 0
Obesity 308864 0
Condition category
Condition code
Metabolic and Endocrine 307787 307787 0 0
Diabetes
Diet and Nutrition 307788 307788 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the first 4 weeks, participants are instructed to measure their capillary or interstitial glucose (depending on whether they are randomised to Group A or B) every time they want to eat (or drink a caloric beverage). Participants are then permitted to eat only if their glucose concentration is below their individualised cut-off. Individualised glucose cut-offs are calculated as the average fasting glucose concentrations over two mornings, using the first glucose readings that are measured by fingerprick (for Group A) or scanned with the reader (from Group B). If glucose is too high, they are instructed to choose an activity that distracts them from food, and wait at least 15 minutes before testing glucose again (if hungry). Participants can consume hypocaloric drinks (e.g. black coffee or diet soft drinks) at any time.

Alongside the glucose monitoring, participants indicate how hungry they were prior to measuring their glucose (1 to 10 scale), glucose concentration (if measured), and whether food was eaten (yes/no). Participants complete this hunger training ‘diary’ daily for the first month, and for one week per month thereafter (a total of 63 days).

Both hunger training arms receive the same guidance and support throughout the trial, but the mechanism for measuring glucose will differ. In Group A, participants will measure their capillary glucose from a finger prick sample by portable glucometer (Abbott Freestyle Optium Glucose Meter, Australia). In Group B, participants will use the Freestyle Libre Flash Glucose Monitoring system (Abbott Diabetes Care, Australia) to measure interstitial glucose.
Intervention code [1] 301875 0
Prevention
Intervention code [2] 301876 0
Lifestyle
Intervention code [3] 301877 0
Behaviour
Comparator / control treatment
Both arms receive the same treatment, only the mechanism for measuring glucose will differ.
Control group
Active

Outcomes
Primary outcome [1] 306791 0
Adherence: number of glucose measurements as measured by glucose reader
Timepoint [1] 306791 0
1 month after intervention commencement
Primary outcome [2] 306792 0
Adherence: number of booklet entries in study-specific diary
Timepoint [2] 306792 0
6 months after intervention commencement
Secondary outcome [1] 349657 0
Body weight as measured with digital scale
Timepoint [1] 349657 0
0, 6 months after intervention commencement
Secondary outcome [2] 349658 0
HbA1c as measured by particle enhanced immunoagglutination assay (capillary blood sample)
Timepoint [2] 349658 0
0, 6 months after intervention commencement
Secondary outcome [3] 349659 0
Intuitive Eating Scale 2
Timepoint [3] 349659 0
0, 1, 6 months after intervention commencement
Secondary outcome [4] 349660 0
Dutch Eating Behaviour Questionnaire
Timepoint [4] 349660 0
0, 1, 6 months after intervention commencement
Secondary outcome [5] 349661 0
Depression and Stress Scale (DASS 21)
Timepoint [5] 349661 0
0, 6 months after intervention commencement
Secondary outcome [6] 349662 0
Health related quality of life (EQ5L3D)
Timepoint [6] 349662 0
0, 6 months after intervention commencement
Secondary outcome [7] 349663 0
Qualitative feedback on acceptability of intervention and glucose measurement device, as well barriers and enablers of following intervention, as assessed by semi-structured interviews
Timepoint [7] 349663 0
1 and 6 months after intervention commencement
Secondary outcome [8] 349664 0
Body composition (with BIA)
Timepoint [8] 349664 0
0, 6 months after intervention commencement
Secondary outcome [9] 349665 0
Satiety as assessed by Hunger Scale (1-10)
Timepoint [9] 349665 0
1 month after intervention commencement
Secondary outcome [10] 349839 0
Hunger training questionnaire, specifically designed for use in this study
Timepoint [10] 349839 0
1, 6 months after intervention commencement

Eligibility
Key inclusion criteria
Body mass index of 30kg/m2 or more, willing to measure blood glucose by fingerprick sample and continuous glucose monitor
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, lactating, inability or unwillingness to comply with intervention requirement, taking medication that affects weight (e.g. Zyprexa, clozapine, paroxetine), known allergy to surgical adhesive, extensive skin changes/diseases on upper arm (application site of the flash sensor), has X-ray, MRI, or CT appointment scheduled during the period of study participation and cannot reschedule for a time before or after study participation.

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)
Central randomisation by computer, unable to be access prior to participant randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with random length blocks, stratified by sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study testing feasibility and adherence, power calculations are not required. Differences between the two groups will be compared by t-test or regression as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2018
Actual
21/08/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
23/10/2018
Date of last data collection
Anticipated
Actual
1/05/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 10662 0
New Zealand
State/province [1] 10662 0
Otago

Funding & Sponsors
Funding source category [1] 300154 0
University
Name [1] 300154 0
University of Otago
Country [1] 300154 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 299556 0
None
Name [1] 299556 0
Address [1] 299556 0
Country [1] 299556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300984 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300984 0
Ethics committee country [1] 300984 0
New Zealand
Date submitted for ethics approval [1] 300984 0
15/05/2018
Approval date [1] 300984 0
16/07/2018
Ethics approval number [1] 300984 0
18/STH/105

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

Contacts
Principal investigator
Name 85518 0
Dr Michelle Jospe
Address 85518 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 85518 0
New Zealand
Phone 85518 0
+64210375002
Fax 85518 0
Email 85518 0
[email protected]
Contact person for public queries
Name 85519 0
Michelle Jospe
Address 85519 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 85519 0
New Zealand
Phone 85519 0
+64210375002
Fax 85519 0
Email 85519 0
[email protected]
Contact person for scientific queries
Name 85520 0
Michelle Jospe
Address 85520 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 85520 0
New Zealand
Phone 85520 0
+64210375002
Fax 85520 0
Email 85520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data underlying published results
When will data be available (start and end dates)?
Beginning immediately after publication and ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Electronically, csv file access subject to approvals by Principal Investigator


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
SourceTitleYear of PublicationDOI
Embase'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: A pilot study.2019https://dx.doi.org/10.1136/bmjopen-2019-032248
N.B. These documents automatically identified may not have been verified by the study sponsor.