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Trial registered on ANZCTR


Registration number
ACTRN12609000239268
Ethics application status
Approved
Date submitted
30/04/2009
Date registered
11/05/2009
Date last updated
9/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational study of an oral volume restriction device for slowing eating and achieving weight loss in overweight and obese individuals
Scientific title
Observational study of an oral volume restriction device for slowing eating and achieving weight loss in overweight and obese individuals
Secondary ID [1] 253266 0
Weight loss with an oral device
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 4698 0
Condition category
Condition code
Diet and Nutrition 5012 5012 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Longitudinal observational study of 20 subjects with Body Mass Index (BMI) range 27-29.9 kg/m2 with some level of comorbidity or BMI range 30-32.9 with or without comorbidity, to evaluate the efficacy, acceptability and compliance of using a novel oral volume restrictive device (the Sensor Monitored Alimentary Restriction Therapy (SMART) device manufactured by Scientific Intake, Atlanta GA, USA) to achieve weight loss. The device is inserted into the oral cavity immediately prior to ingestion of food or calorie-containing drinks, and is removed, cleansed and stored until reinsertion, ideally during the next meal or snack. The overall duration of the study is 4 months with an option of follow-up visits at 9- and 12-months.
Intervention code [1] 4459 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5852 0
Weight loss greater than 5% body weight by weighing participants on scales
Timepoint [1] 5852 0
4 months after intervention commencement
Secondary outcome [1] 241877 0
Compliance: subjects who use the device 5 or more days a week and for at least 30% of all meals and snacks. This outcome is assessed by self report
Timepoint [1] 241877 0
4 months after intervention commencement
Secondary outcome [2] 241878 0
Acceptability: the number of subjects that can place the device and tolerate the use of the device during a small meal. Outcome will be assessed by self report
Timepoint [2] 241878 0
4 months after intervention commencement

Eligibility
Key inclusion criteria
BMI range 27-29.9 kg/m2 with some level of comorbidity or BMI range 30-32.9 with or without comorbidity; weight stable +/- 5% over the preceding 6 months; have had a weight problem of at least 2 years; have made substantial attempts to lose weight in the past which has resulted in weight loss but was followed by eventual weight regain; must be from the Melbourne area and have no problem making a strong commitment to frequent and regular follow-up for at least 6 months after receiving the device; participants must have had a dental examination within the preceding 12 months and have healthy teeth and oral cavity, and provide the name and accurate contact information for their dentist; patients must have normal functioning of the mouth and no swallowing abnormality; patient agrees that the device remains the property of the research team unless it is agreed that the participant has completed 80% of the follow up requirements of the study which must include the third visit and the 4-month follow up visit; all participants must have attended the initial consultation and completed satisfactorily all laboratory tests and questionnaires before the second visit.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to complete all the questionnaires and tests in English; patients participating or intending to participate in another weight loss program during the next year; patients with any significant cardiac, pulmonary, hepatic, renal or untreated endocrine condition. (Those with treated type-2 diabetes – up to 6 subjects - or thyroid disease would be acceptable); any cancer or internal malignancy; alcoholism or drug abuse; patients on medications known to stimulate appetite and lead to weight gain; major psychiatric or neurological illness, any neurological condition that may affect oral functioning or swallowing; known allergy to oral appliances, or to the impression material (vinyl polysiloxane) or the materials (acrylics and stainless steel, with a small microchip totally surrounded by the acrylic material) used to make the SMART device; a dermatological condition that may involve the lips or any part of the oral cavity; a history of oral or dental disease that may interfere with the safe use of the device; patients using dentures or any partial denture or removable oral device; patients missing three or more upper teeth; any condition that in the view of the assessing physician may interfere with the effectiveness or safety of the SMART device; failure to complete all lab test and questionnaires before the second visit; patients who are self-described slow eaters or whose eating evaluation indicates they are slow eaters or patients who consume a majority of their calories in snacks rather than at mealtimes; significant weight loss or gain between the first visit and the placement of the SMART device (5% of body weight).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4878 0
Commercial sector/Industry
Name [1] 4878 0
Scientific Intake
Address [1] 4878 0
3575 Piedmont Road NE
Building 15, Suite 1050
Atlanta, GA 30305
Country [1] 4878 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Department of General Practice
Building 1, 270 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 4411 0
None
Name [1] 4411 0
Address [1] 4411 0
Country [1] 4411 0
Other collaborator category [1] 656 0
Other Collaborative groups
Name [1] 656 0
Baker IDI Heart and Diabetes Institute
Address [1] 656 0
75 Commercial Road,
Melbourne VIC 3004
Country [1] 656 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6944 0
Alfred Hospital Hunan Research Ethics Committee (HREC)
Ethics committee address [1] 6944 0
Commercial Road,
Melbourne VIC 3004
Ethics committee country [1] 6944 0
Australia
Date submitted for ethics approval [1] 6944 0
12/01/2009
Approval date [1] 6944 0
Ethics approval number [1] 6944 0
7/09

Summary
Brief summary
The purpose of this study is to explore the efficacy, acceptability and compliance associated with using the SMART device for weight loss in overweight and obese adults, and to gain experience with this device in Australia.
Hypothesis: The use of the device will reduce oral food intake and lead to a substantial weight loss when combined with dietary advice and a physical activity program
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29550 0
Address 29550 0
Country 29550 0
Phone 29550 0
Fax 29550 0
Email 29550 0
Contact person for public queries
Name 12797 0
Associate Professor John Dixon
Address 12797 0
Monash University,
Department of General Practice
Building 1, 270 Ferntree Gully Road,
Notting Hill VIC 3168
Country 12797 0
Australia
Phone 12797 0
+61 3 9902 4511
Fax 12797 0
+61 3 8575 2233
Email 12797 0
kay.jones@med.monash.edu.au
Contact person for scientific queries
Name 3725 0
Associate Professor John Dixon
Address 3725 0
Monash University,
Department of General Practice
Building 1, 270 Ferntree Gully Road,
Notting Hill VIC 3168
Country 3725 0
Australia
Phone 3725 0
+61 3 9902 4511
Fax 3725 0
+61 3 8575 2233
Email 3725 0
john.dixon@ med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary