This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up
This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up. The objective is to demonstrate the effectiveness of the Elira System combined with a moderate intensity lifestyle therapy program compared to a sham device combined with a moderate intensity lifestyle therapy program control group at 3-months on weight management for participants who are overweight and/or with Class 1 obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
395
Using a 7-day/week wearable TENS device controlled by a Smart Phone App combined with moderate intensity lifestyle therapy,
Using the sham (control) device combined with a moderate intensity lifestyle follow-up
Honor Health
Scottsdale, Arizona, United States
EmVenio
Santa Monica, California, United States
A New You
Miami, Florida, United States
Advanced Research for Health Improvement, LLC (ARHI)
Naples, Florida, United States
A difference in Percent Total Body Weight Loss (%TBWL)
A difference in Percent Total Body Weight Loss (%TBWL) of greater than 0 (true mean percent of 2%) at 3-months in the Elira System (active) treatment group when compared to the sham (control) group who complete 3-months of treatment
Time frame: Three Months
A responder rate of at least 35% in the active treatment
A responder rate of at least 35% in the active treatment participants who complete 3-months of treatment, calculated as the percentage achieving at least a 5% TBWL at 3-months
Time frame: Three Months
Changes in appetite as measured by Appetite Visual Analogue Scale (VAS)
Changes in appetite as measured by Appetite Visual Analogue Scale (VAS) from Baseline to 3-months in the active treatment group compared to the sham control group
Time frame: Three Months
Changes in BMI
Changes in BMI from Baseline to 3-months in the active treatment group compared to the sham control group
Time frame: Three Months
Changes in eating behaviors as measured by TFEQ scores
Changes in eating behaviors as measured by TFEQ scores from Baseline to 3-months in the active treatment group compared to the sham control group
Time frame: Three Months
Impact of weight on quality of life (IWQOL-Lite) scores
Impact of weight on quality of life (IWQOL-Lite) scores from Baseline to 3-months in in the active treatment group compared to the sham control group
Time frame: Three Months
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Washington University
St Louis, Missouri, United States
West County OB/GYN Specialists
St Louis, Missouri, United States