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Is Hunger Training the answer to reducing the risk of Diabetes? A pilot study

Is Hunger Training the answer to reducing the risk of Diabetes? A pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001257257
Enrollment
40
Registered
2018-07-25
Start date
2018-08-21
Completion date
2018-10-23
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Body mass index of 30kg/m2 or more, willing to measure blood glucose by fingerprick sample and continuous glucose monitor

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026