Overweight and ObesitySMARTNCT02119299
Safety and Efficacy of the SMART Device for Overweight and Obese Adults
A study testing SMART device in people with Overweight and Obesity, run by Scientific Intake Limited Co. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- SMART device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigative Site
Coral Gables, Florida, 33134
Investigative Site
San Diego, California, 92108
Investigative Site
Sugar Land, Texas, 77479
Investigative Site
Waterbury, Connecticut, 06708
About this study
Official title: A Prospective, Single Arm, Multicenter Study Evaluating the Safety and Weight Loss Efficacy of the SMART Device + DVD Weight Loss Education for Overweight and Obese Adults
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.
- Conditions
- Overweight and Obesity
- Being tested
- SMART device
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART deviceDevice
Also called Sensor Monitored Alimentary Restriction Therapy
Sensor Monitored Alimentary Restriction Therapy (SMART) device
| Study group | Role | What they receive |
|---|---|---|
| SMART device | Experimental | Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device Receives: Device: SMART device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0
Measured: 16 weeks
Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0
Measured: 16 weeks
Secondary outcomes (6)
Mean Percentage Excess Weight Loss (EWL)
Measured: 16 weeks
Mean Absolute Weight Loss (kg)
Measured: 16 weeks
Proportion of Subjects Achieving ≥4% Weight Loss
Measured: 16 weeks
Proportion of Subjects Achieving ≥12% EWL
Measured: 16 weeks
Percentage Total Body Loss and Treatment Compliance Correlation
The measured relationship between SMART device usage and total weight loss.
Measured: 16 weeks
Device Compliance
Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Intake Limited Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William H Longley, Study director, Scientific Intake
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119299
- Sponsor's protocol ID
- 0007
- Acronym
- SMART
- Status last verified
- Jul 2017
- First submitted
- 21 Mar 2014
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multicenter Study Evaluating the Safety and Weight Loss Efficacy of the SMART Device + DVD Weight Loss Education for Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT02119299
- Acronym / sponsor ID
- SMART / 0007
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Scientific Intake Limited Co.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART device | Experimental | Device: SMART deviceUse of Sensor Monitored Alimentary Restriction Therapy (SMART) device |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART deviceAlso: Sensor Monitored Alimentary Restriction TherapySensor Monitored Alimentary Restriction Therapy (SMART) device | Device | SMART device |
Primary outcome
Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0
Time frame: 16 weeks
Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0
Time frame: 16 weeks
6 secondary outcomes
Mean Percentage Excess Weight Loss (EWL)
Time frame: 16 weeks
Mean Absolute Weight Loss (kg)
Time frame: 16 weeks
Proportion of Subjects Achieving ≥4% Weight Loss
Time frame: 16 weeks
Proportion of Subjects Achieving ≥12% EWL
Time frame: 16 weeks
Percentage Total Body Loss and Treatment Compliance Correlation
Time frame: 16 weeks
Device Compliance
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Longley study director
Scientific Intake
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART device in people with Overweight and Obesity, run by Scientific Intake Limited Co. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.