TENS Active Treatment for Obesity

Phase-Based Progress Estimates
Honor Health, Scottsdale, AZObesityTENS Active Treatment - Device
18 - 65
All Sexes
What conditions do you have?

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Three Months

Three Months
A difference in Percent Total Body Weight Loss (%TBWL)
A responder rate of at least 35% in the active treatment
Changes in BMI
Changes in appetite as measured by Appetite Visual Analogue Scale (VAS)
Changes in eating behaviors as measured by TFEQ scores
Impact of weight on quality of life (IWQOL-Lite) scores

Trial Safety

Trial Design

2 Treatment Groups

TENS Active Treatment
1 of 2
Sham Control Device
1 of 2

Experimental Treatment

Non-Treatment Group

325 Total Participants · 2 Treatment Groups

Primary Treatment: TENS Active Treatment · Has Placebo Group · N/A

TENS Active Treatment
Experimental Group · 1 Intervention: TENS Active Treatment · Intervention Types: Device
Sham Control Device
ShamComparator Group · 1 Intervention: Sham Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: three months

Who is running the clinical trial?

Elira, Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.