None listed
Conditions
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
Interventions
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 o
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.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed