Safety and Efficacy of the SMART Device for Overweight and Obese Adults

• Sponsor: Scientific Intake Limited Co. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02119299
• Collaborator: (none)
• Enrollment: 76
• Locations: 4
• Arm: 1
• Duration (Months): 10.1
• Patients Per Site: 19
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Device: SMART device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SMART device Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device	Device: SMART device; Sensor Monitored Alimentary Restriction Therapy (SMART) device; Other Names: Sensor Monitored Alimentary Restriction Therapy

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0 [16 weeks]

2. Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0 [16 weeks]

Secondary Outcome Measures

1. Mean Percentage Excess Weight Loss (EWL) [16 weeks]

2. Mean Absolute Weight Loss (kg) [16 weeks]

3. Proportion of Subjects Achieving ≥4% Weight Loss [16 weeks]

4. Proportion of Subjects Achieving ≥12% EWL [16 weeks]

5. Percentage Total Body Loss and Treatment Compliance Correlation [16 weeks]

   The measured relationship between SMART device usage and total weight loss.

6. Device Compliance [Week 16]

   Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	San Diego	California	United States	92108
2	Investigative Site	Waterbury	Connecticut	United States	06708
3	Investigative Site	Coral Gables	Florida	United States	33134
4	Investigative Site	Sugar Land	Texas	United States	77479

Sponsors and Collaborators

• Scientific Intake Limited Co.

Investigators

• Study Director: William H Longley, Scientific Intake

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scientific Intake Limited Co.
• ClinicalTrials.gov Identifier: NCT02119299
• Other Study ID Numbers: 0007
• First Posted: Apr 21, 2014
• Last Update Posted: Jul 17, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Period Title: Overall Study
STARTED	76
COMPLETED	67
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Overall Participants	76
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	76 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (7.92)
Sex: Female, Male (Count of Participants)
Female	67 88.2%
Male	9 11.8%
Region of Enrollment (participants) [Number]
United States	76 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Count of Participants [Participants]	12 15.8%

2. Primary Outcome

Title	Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Mean (Standard Deviation) [% TBL]	2.93 (3.531)

3. Secondary Outcome

Title	Mean Percentage Excess Weight Loss (EWL)
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Mean (Standard Deviation) [percentage of excess weight loss]	18.76 (24.51)

4. Secondary Outcome

Title	Mean Absolute Weight Loss (kg)
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Mean (Standard Deviation) [Body weight (kg)]	2.35 (2.99)

5. Secondary Outcome

Title	Proportion of Subjects Achieving ≥4% Weight Loss
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Count of Participants [Participants]	16 21.1%

6. Secondary Outcome

Title	Proportion of Subjects Achieving ≥12% EWL
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Count of Participants [Participants]	24 31.6%

7. Secondary Outcome

Title	Percentage Total Body Loss and Treatment Compliance Correlation
Description	The measured relationship between SMART device usage and total weight loss.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per Protocol Population

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Number [Pearson correlation]	.025

8. Secondary Outcome

Title	Device Compliance
Description	Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
Measure Participants	40
Mean (Standard Deviation) [% of eating episodes with device use]	69 (14.13)

Adverse Events

Arm/Group Title	SMART Device
Arm/Group Description	Use of Sensor Monitored Alimentary Restriction Therapy (SMART) device SMART device: Sensor Monitored Alimentary Restriction Therapy (SMART) device
All Cause Mortality
	SMART Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SMART Device
	Affected / at Risk (%)	# Events
Total	1/76 (1.3%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/76 (1.3%)	1
Other (Not Including Serious) Adverse Events
	SMART Device
	Affected / at Risk (%)	# Events
Total	0/76 (0%)

Limitations/Caveats

Lower percentage of TBL reported due to initial endpoint specifications.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.