This trial tests a device combined with lifestyle changes to treat overweight/obese people. It compares the device to a sham device to see if it's safe and effective.
2 Primary · 4 Secondary · Reporting Duration: Three Months
2 Treatment Groups
TENS Active Treatment
1 of 2
Sham Control Device
1 of 2
325 Total Participants · 2 Treatment Groups
Primary Treatment: TENS Active Treatment · Has Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 65 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Does this testing protocol have any age restrictions?
"This research study is seeking individuals aged 18 and above, with a maximum age of 65 for eligibility." - Anonymous Online Contributor
Are there any available opportunities to participate in this study at present?
"According to clinicaltrials.gov, this particular medical investigation is actively seeking participants who meet its inclusion criteria; it was initially advertised on July 29th 2022 and recently updated on January 6th 2023." - Anonymous Online Contributor
What is the participant capacity of this clinical trial?
"In this trial, 325 qualified participants are sought. There is a variety of medical sites that eligible patients can choose from, such as EmVenio in Santa Monica and A New You in Miami." - Anonymous Online Contributor
How geographically dispersed is the execution of this medical experiment?
"This trial is administered at various locations across the country, such as EmVenio in Santa Monica and A New You in Miami. Additionally, Advanced Research for Health Improvement (ARHI) based in Naples and three other sites are taking part." - Anonymous Online Contributor
What is the primary intent of this research endeavor?
"The primary assessment of this experiment, which will span the period of 3 months, is to quantify a response rate over 35% in active treatment. Secondary measurements include comparison between baseline and 3-month BMI values from both the control and experimental arms; changes in dietary habits as judged by TFEQ scores; and alterations in quality of life (IWQOL-Lite) scores." - Anonymous Online Contributor
Are there particular criteria for individuals to qualify for participation in this research?
"This clinical trial is seeking 325 adults aged between 18 and 65 with mild obesity. In order to be eligible, patients must have a BMI of 25 to 35 kg/ m2; proficiency in either English or Spanish; access to Wi-Fi internet for the duration of the study; ability to use touch screen handheld smart phones; willingness and capacity to adhere to assigned therapy throughout the study period, diet & exercise recommendations, as well as exclusion criteria from other trials within 30 days before enrollment. For female participants of childbearing potential (FOCBP), they must also present negative urine pregnancy tests upon screening and enrolling visits while agreeing on contraceptive measures" - Anonymous Online Contributor