Efficacy Study for SD Device
Efficacy Study of SD Device for Overweight and Obesity Treatment
1 other identifier
interventional
150
1 country
2
Brief Summary
The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
February 16, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 22, 2016
January 1, 2016
3.9 years
January 12, 2012
January 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Body Weight
Each participant's body weight will be measured at his/her beginning of the trial. This measure will become the participant's body weight base-line. Once in every 2 weeks the body weight will be taken again and will be compared to base-line and to previous body weight measures of the participant taken during the study.
once in every two weeks up to 13 weeks for each participant
Secondary Outcomes (1)
Change from Baseline in Waist Circumference
once in every two weeks up to 13 weeks for each participant
Study Arms (3)
Study arm
EXPERIMENTALThe Arm who uses the real study device Daily use of SD device
Control Arm
SHAM COMPARATORDaily use of Sham comperator
Staudy2 arm
EXPERIMENTALUses the under study device in a different time frames Daily use of SD device in a different time frames than of Study Arm
Interventions
The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance. The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss. The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements.
The participants in the Control arm of the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the placebo. During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the placebo is done by the control study participants during the day every day throughout the study period. The placebo can be easily used by the participants themselves in their regular environment and does not require professional assistance.
Eligibility Criteria
You may qualify if:
- BMI 30-41.99
- AGE 18-65 years
You may not qualify if:
- Pregnant Women,
- Type I and II diabetes,
- People with disfunctioning of thyroid gland
- Hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Emek Medical Center
Afula, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dror Dicker, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2012
First Posted
February 16, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
January 22, 2016
Record last verified: 2016-01