ANZCTR - Registration

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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]

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

Obesity

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Adherence: number of glucose measurements as measured by glucose reader

Timepoint [1]

1 month after intervention commencement

Primary outcome [2]

Adherence: number of booklet entries in study-specific diary

Timepoint [2]

6 months after intervention commencement

Secondary outcome [1]

Body weight as measured with digital scale

Timepoint [1]

0, 6 months after intervention commencement

Secondary outcome [2]

HbA1c as measured by particle enhanced immunoagglutination assay (capillary blood sample)

Timepoint [2]

0, 6 months after intervention commencement

Secondary outcome [3]

Intuitive Eating Scale 2

Timepoint [3]

0, 1, 6 months after intervention commencement

Secondary outcome [4]

Dutch Eating Behaviour Questionnaire

Timepoint [4]

0, 1, 6 months after intervention commencement

Secondary outcome [5]

Depression and Stress Scale (DASS 21)

Timepoint [5]

0, 6 months after intervention commencement

Secondary outcome [6]

Health related quality of life (EQ5L3D)

Timepoint [6]

0, 6 months after intervention commencement

Secondary outcome [7]

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]

1 and 6 months after intervention commencement

Secondary outcome [8]

Body composition (with BIA)

Timepoint [8]

0, 6 months after intervention commencement

Secondary outcome [9]

Satiety as assessed by Hunger Scale (1-10)

Timepoint [9]

1 month after intervention commencement

Secondary outcome [10]

Hunger training questionnaire, specifically designed for use in this study

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 56
Dunedin 9054

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
PO Box 5013
Wellington, 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/05/2018

Approval date [1]

16/07/2018

Ethics approval number [1]

18/STH/105

Summary

Brief summary

One-quarter of New Zealand adults have pre-diabetes; half will develop type 2 diabetes within 7-8 years without suitable intervention. Screening for pre-diabetes currently occurs in NZ but treatment pathways are limited as stretched resources try to cope with established diabetes. The most important factor reducing the risk of progression to diabetes in those with pre-diabetes is weight loss. Although large clinical trials have demonstrated that intensive lifestyle intervention can reduce diabetes risk, simpler but still effective alternatives are also required. In this pilot, we will test the feasibility of using ‘hunger training’ as a means of facilitating weight loss in those with pre-diabetes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michelle Jospe

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64210375002

Fax

michelle.jospe@otago.ac.nz

Contact person for public queries

Name

Michelle Jospe

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64210375002

Fax

michelle.jospe@otago.ac.nz

Contact person for scientific queries

Name

Michelle Jospe

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64210375002

Fax

michelle.jospe@otago.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: A pilot study.	2019	https://dx.doi.org/10.1136/bmjopen-2019-032248

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically