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Trial registered on ANZCTR


Registration number
ACTRN12616001198415
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
31/08/2016
Date last updated
25/11/2019
Date data sharing statement initially provided
12/12/2018
Date results information initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility study to evaluate the effect of a fixed magnetic oral device and liquid diet on weight loss
Scientific title
A Feasibility study to evaluate the effect of a fixed magnetic oral device and liquid diet on weight loss in obese adults
Secondary ID [1] 289592 0
None
Universal Trial Number (UTN)
UTN: U111111771101
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 299362 0
Condition category
Condition code
Diet and Nutrition 299350 299350 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A dental inspection will confirm each individual’s suitability for the study and baseline screening tests will be performed including a medical history, dietary assessment, and measurement of weight and height. Separation elastics will be placed by a dental surgeon to allow for a reversible separation of the teeth. This appointment should take 30-45min. When adequate separation of the teeth is achieved after 2 weeks of continuous use of the elastics, a dental impression will be taken to allow for the manufacture of the dental device. This appointment should take 30-45min. The device is cemented to four of the patients’ upper and lower teeth by a dental surgeon. It consists of stainless steel orthodontic-type metal bands wrapped around four posterior teeth. A closed magnet and its keeper are attached to the upper and lower bands, which then restricts mouth opening. It is estimated that device fitting will take 1-2h per patient. A safety-feature allows the disengagement of the device in case of an emergency (e.g. vomiting).
Instead of eating solid food, the subjects will be given a liquid diet for 28 days. The 4-week low calorie diet (LCD) consists of 1200kcal/day (4 Fortisip bottles per day, plus some extra low calorie liquids such as tea, coffee and diet lemonade). During this 4-week phase participants will see a dietitian on a weekly basis to discuss acceptability of the liquid diet and fill out food diaries to monitor adherence to a low-calorie diet. This appointment should take 30-45min.
During the study, ten participants will receive dental, dietetic and medical supervision before, during and after device placement. Subjects will be reviewed 24 hours and at 3, 7, 14, 21 and 28 days after the device has been placed. The comfort and tolerability of the device will be assessed, together with the resultant weight loss, at each time point. During the feasibility study, qualitative and quantitative data will be collected on: tolerance of the device, effect on oral health, weight loss, and acceptability to patients. These will be assessed using standard and modified Quality of Life (QoL) questionnaires. Data collected will inform further development and modification of the device, if needed. The device will be removed after 4 weeks.

Intervention code [1] 295199 0
Treatment: Devices
Intervention code [2] 295609 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298818 0
Change in body weight measured using a calibrated digital weight scale
Timepoint [1] 298818 0
Weekly during the 4 week intervention
Secondary outcome [1] 325300 0
Tolerability of the device measured using a 5-Point Likert Scale
Timepoint [1] 325300 0
Weekly during the 4 week intervention
Secondary outcome [2] 325399 0
Maintenance of good oral health assessed by dental surgeon using a 5-Point Likert Scale
Timepoint [2] 325399 0
28 days post-intervention
Secondary outcome [3] 327269 0
Impact of weight in the subjects quality of life measured using the IWQOL-Lite Questionnaire
Timepoint [3] 327269 0
Measured pre-treatment and 28 days post-intervention

Eligibility
Key inclusion criteria
Inclusion criteria include a BMI of over 30, no major co-occurring health conditions that may affect the ability of participating in the study, and a healthy mouth with a sound posterior dentition. Males and females aging 20-65 of all ethnicities will be invited to participate.
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants using continuous positive airway pressure (CPAP) devices to manage sleep apnoea are not eligible. Any patient who is on oral medication that cannot be give in in liquid form; diabetic patients on insulin; and any patient with diabetes on oral hypoglycaemic therapy will be excluded from the study.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8000 0
New Zealand
State/province [1] 8000 0
Otago

Funding & Sponsors
Funding source category [1] 293997 0
University
Name [1] 293997 0
Faculty of Dentistry, University of Otago
Address [1] 293997 0
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country [1] 293997 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Faculty of Dentistry
University of Otago
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292814 0
None
Name [1] 292814 0
None
Address [1] 292814 0
Country [1] 292814 0
Other collaborator category [1] 279057 0
Individual
Name [1] 279057 0
Prof. Jim Mann
Address [1] 279057 0
Edgar Diabetes and Obesity Research
Department of Medicine
9th Floor
Dunedin Hospital
Great King Street
Dunedin 9016
New Zealand
Country [1] 279057 0
New Zealand
Other collaborator category [2] 279058 0
Individual
Name [2] 279058 0
Dr. Patrick Manning
Address [2] 279058 0
Edgar Diabetes and Obesity Research
Department of Medicine
9th Floor
Dunedin Hospital
Great King Street
Dunedin 9016
New Zealand
Country [2] 279058 0
New Zealand
Other collaborator category [3] 279059 0
Individual
Name [3] 279059 0
Dr. Jonathan Bodansky
Address [3] 279059 0
The Leeds Teaching Hospital NHS Trust
St James’s University Hospital
Beckett Street
Leeds LS9 7TF
UK
Country [3] 279059 0
United Kingdom
Other collaborator category [4] 279060 0
Individual
Name [4] 279060 0
Dr. Richard Hall
Address [4] 279060 0
R M Hall Consultancy
11 Alwoodley Chase, Harrogate Road,
Leeds LS17 8ER
West Yorkshire
UK
Country [4] 279060 0
New Zealand
Other collaborator category [5] 279063 0
Individual
Name [5] 279063 0
Carolina Loch
Address [5] 279063 0
Sir John Walsh Research Institute
Faculty of Dentistry
University of Otago
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country [5] 279063 0
New Zealand
Other collaborator category [6] 280232 0
University
Name [6] 280232 0
Jithendra Ratnayake
Address [6] 280232 0
Sir John Walsh Research Institute, Faculty of Dentistry, 71 Frederick Street, Dunedin 9016., New Zealand
Country [6] 280232 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295412 0
Health and Disability Ethics Commitee
Ethics committee address [1] 295412 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 295412 0
New Zealand
Date submitted for ethics approval [1] 295412 0
20/05/2016
Approval date [1] 295412 0
13/06/2016
Ethics approval number [1] 295412 0
16/NTB/89

Summary
Brief summary
This is an open label uncontrolled intervention study of 1200 calorie liquid diet plus an oral magnetic device which is attached to the back 4 teeth to prevent chewing. The aim is to facilitate weight loss of 10% over 4 weeks in participants with BMI >30, aged 20-65 with a healthy mouth and no major contraindication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62658 0
Prof Paul A. Brunton
Address 62658 0
Faculty of Dentistry
University of Otago
310 Great King St, North Dunedin
Dunedin 9016
New Zealand

Country 62658 0
New Zealand
Phone 62658 0
+64 3 4797039
Fax 62658 0
Email 62658 0
paul.brunton@otago.ac.nz
Contact person for public queries
Name 62659 0
Prof Paul A. Brunton
Address 62659 0
Faculty of Dentistry
University of Otago
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country 62659 0
New Zealand
Phone 62659 0
+64 3 4797039
Fax 62659 0
Email 62659 0
paul.brunton@otago.ac.nz
Contact person for scientific queries
Name 62660 0
Prof Paul A. Brunton
Address 62660 0
Faculty of Dentistry
University of Otago
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country 62660 0
New Zealand
Phone 62660 0
+64 3 4797039
Fax 62660 0
Email 62660 0
paul.brunton@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure confidentiality
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 617 0
Study protocol
Citation [1] 617 0
Link [1] 617 0
Email [1] 617 0
Other [1] 617 0
Type [2] 618 0
Informed consent form
Citation [2] 618 0
Link [2] 618 0
Email [2] 618 0
Other [2] 618 0
Type [3] 619 0
Ethical approval
Citation [3] 619 0
Link [3] 619 0
Email [3] 619 0
Other [3] 619 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary