Observational study of an oral volume restriction device for slowing eating and achieving weight loss in overweight and obese individuals
- Conditions
- Overweight and obesityDiet and Nutrition - Obesity
- Registration Number
- ACTRN12609000239268
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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.
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss greater than 5% body weight by weighing participants on scales[4 months after intervention commencement]
- Secondary Outcome Measures
Name Time Method 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[4 months after intervention commencement];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[4 months after intervention commencement]