Overweight and Obesity
Conditions
Brief summary
The purpose of this study is to demonstrate that (1) we will observe at least 40% of the subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared to Week 0 is ≥4% in the Per Protocol population.
Interventions
DEVICESMART device
Sensor Monitored Alimentary Restriction Therapy (SMART) device
Sponsors
Scientific Intake Limited Co.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject willing and able to sign an informed consent for the study and has signed the IRB approved Information and Consent form for this study. * Subject is age 18 to 49 years inclusive. * Subject has a BMI between 27 and 35 kg/m² inclusive. Subject reports weight has been stable (no increase or decrease of 3% or more) in the last 3 months. * Subject reports that he/she has had a dental check-up within the last 12 months. * Subject reports that he/she is under the care of a dentist or orthodontist that the HCP may contact and provides name and location of the dental professional. * Subject able to participate fully in and for the full duration of the study. * Subject agrees to sign a behavioral contract describing that they understand the mechanism by which the device reduces food intake, that they will use the device during all meals and eating episodes (including snacks and while consuming sugar-sweetened liquids), that they will properly care for the device and that they will attend all study visits. * Subject is fully ambulatory. * Subject has normal condition, anatomy and function of the oral cavity as self-reported and confirmed by the trained health care provider. * If female, the subject is; a. not pregnant (or lactating), and b. using and will continue to use adequate contraception throughout participation in the study. * Subject reports no functional problems when swallowing solids or liquids. * Subject lives or works within 25 miles of the study site and has a reliable method of transportation.
Exclusion criteria
* Subject has participated in a weight loss program and/or in a formal weight loss program (commercial, licensed counselor-delivered or medically supervised) in the last three months preceding anticipated study entry. * Subject reports history of, or current, clinically significant disease, including: cardiovascular, pulmonary, gastrointestinal, urological, dermatological, central or peripheral nervous system, or endocrine disease or condition (other than type 2 diabetes that does not require insulin or sulfonylurea). * Subject has a history of bariatric surgery. * In the opinion of the Investigator, subject has respiratory, dental, oral, or neurological disease or condition that might interfere with use or safety of the SMART device. * Subject has compromised oral health (e.g., decay, infection, abscess, loose or cracked teeth, inflamed oral tissue, receding gums, and periodontal disease). * Subject uses antipsychotic medication. If the subject is on a stable dose (3 months or more) of an antidepressant he/she can be enrolled in the study. * Subject has type 1 or type 2 diabetes and is taking insulin or sulfonylurea. * Subject has history of malignant disease, other than non-melanoma skin cancer diagnosed within the last five years and successfully treated. * Subject has known allergy to any component of the SMART device. * Subject is a current smoker or user of smokeless tobacco or nicotine gum. * Subject has recent history of drug or alcohol abuse (in last 3 years). * Subject is known to be HIV positive. * Subject has been diagnosed with Sjogren's syndrome or chronic dry mouth * Subject has any of the following conditions in the oral cavity that would preclude fitting and wearing the device: oral deformity, upper arch removable partial dentures, inadequate oral anatomy (e.g., 3 or more loose or missing teeth on the upper arch, molars or pre-molars either missing or worn down to within 4 mm above gum line, teeth with excessive convexity or undercuts that will make placement and removal of the device difficult, an oro-nasal fistula secondary to cleft palate, or a large torus palatinus), veneers, temporary crowns or recently placed osteointegrated dental implants, and any fixed orthodontic appliances (e.g., braces). * Subject is unable to complete the mold-making process. * Subject is currently involved in another clinical trial or intends to participate in one during the study period. * Subjects are excluded if they report the following eating patterns that are less likely to be helped by the SMART device; diagnosis of night eating syndrome\* (wakened by hunger and desire to eat at night); diagnosis of sleep eating\* (unconscious eating while asleep); self-report of consumption of 32 or more ounces of sugar-sweetened beverages per day; self-report of extremely slow eating, such that family members and friends remark on the trait; self-report of a grazing eating pattern, defined as eating or snacking in more than 6 episodes per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0 | 16 weeks |
| Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0 | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving ≥4% Weight Loss | 16 weeks | — |
| Proportion of Subjects Achieving ≥12% EWL | 16 weeks | — |
| Mean Percentage Excess Weight Loss (EWL) | 16 weeks | — |
| Device Compliance | Week 16 | Device compliance is calculated as 100\*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5). |
| Percentage Total Body Loss and Treatment Compliance Correlation | 16 weeks | The measured relationship between SMART device usage and total weight loss. |
| Mean Absolute Weight Loss (kg) | 16 weeks | — |
Countries
United States
Participant flow
Pre-assignment details
Per protocol, there were two screening visits prior to the run-in visit to assess subject eligibility and oral health. A total of 4 visits (2 screening visits, 1 run-in visit and 1 wash-out visit) were included prior to the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| SMART Device Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device
SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | SMART Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 7.92 |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 1 / 76 |
Outcome results
Primary
Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0
Time frame: 16 weeks
Population: Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART Device | Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0 | 2.93 % TBL | Standard Deviation 3.531 |
Primary
Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMART Device | Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0 | 12 Participants |
Secondary
Device Compliance
Device compliance is calculated as 100\*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART Device | Device Compliance | 69 % of eating episodes with device use | Standard Deviation 14.13 |
Secondary
Mean Absolute Weight Loss (kg)
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART Device | Mean Absolute Weight Loss (kg) | 2.35 Body weight (kg) | Standard Deviation 2.99 |
Secondary
Mean Percentage Excess Weight Loss (EWL)
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMART Device | Mean Percentage Excess Weight Loss (EWL) | 18.76 percentage of excess weight loss | Standard Deviation 24.51 |
Secondary
Percentage Total Body Loss and Treatment Compliance Correlation
The measured relationship between SMART device usage and total weight loss.
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMART Device | Percentage Total Body Loss and Treatment Compliance Correlation | .025 Pearson correlation |
Secondary
Proportion of Subjects Achieving ≥12% EWL
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMART Device | Proportion of Subjects Achieving ≥12% EWL | 24 Participants |
Secondary
Proportion of Subjects Achieving ≥4% Weight Loss
Time frame: 16 weeks
Population: Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMART Device | Proportion of Subjects Achieving ≥4% Weight Loss | 16 Participants |