Safety & Effectiveness of TENS Weight Management Compared to a Sham

Prior treatment

• Participant has had a prior bariatric surgical procedure, endoscopic bariatric therapy, or surgery on the stomach.
• Participant has an existing implanted electrical stimulator (e.g., pacemaker, AICD, cochlear implant).
• Participant has had a weight change of ± 5% of his/her Total Body Weight in the 3 months prior to screening.
• Participant has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI.
• Participant has taken weight loss medications including but not limited to OTC medications or any other medication known to cause weight loss or weight gain within the 2 months prior to enrollment.
• Participant is taking Topiramate, Adderall, or Ritalin within the 6 months prior to enrollment.
• Participant is on drug therapy which may alter antral motility or appetite, per Investigator discretion within the 2 months prior to enrollment.
• Prior participation in an Elira sponsored study.

Other illness

• Participant has any known gastrointestinal disorder that in the opinion of the Investigator precludes enrollment into the trial.
• Participant has any significant multisystem disease in the opinion of the Investigator.
• Participant has a history of significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
• Participant has an uncontrolled psychiatric disorder.
• Participant has a diagnosed neurological disease.
• Participant has a skin disorder affecting the thoracic dermatomes.
• Participant has known allergic reaction to materials in the TENS electrodes and/or is otherwise unable to tolerate stimulation with the wearable TENS system. This includes known allergies or sensitivity to latex, nickel and/or hydrogels.
• Participant has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion.
• Participant has a history of eating disorders (Bulimia, Binge Eating, Night Eating Syndrome, Compulsive Overeating) and/or screens positive for Binge Eating as measured by the Binge Eating Score (BES) Questionnaire.
• History of treatment for or current abuse of drugs or alcohol.
• History of cirrhosis or pancreatitis.
• History of COPD or other pulmonary disease that restricts exercise tolerance.
• Immunocompromised due to medications or disease or HIV positive.
• History of severe Covid-19 symptoms requiring hospitalization or history of Covid-19 infection with unresolved symptoms.

Age

• Participant has current and/or a history of cancer with the exception of non-melanoma skin cancer or cervical carcinoma in situ \< 3 years before study enrollment.

Other

• Participant is a Type 2 diabetic.
• For female participants: planned pregnancy within 6 months from study start, active pregnancy, or currently breast feeding.
• Participant has active/has ever had shingles in the abdominal area.
• Participant is actively participating or unwilling to discontinue participation in another weight loss program. (Participants may not enroll in paid or unpaid programs that involve inperson or online coaching during the course of the Elira study.)
• Participant is planning any major medical treatments or surgeries that could cause weight loss during the study.
• Participant works night shift or rotating night shifts that impact scheduled daylight mealtimes.
• Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking).
• Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date.
• A score of 10 or higher on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression.
• Any participant that the Investigator considers inappropriate for the study for medical reasons.
• TSH levels \> 10mU/L or \< 0.1 mU/L.
• A current member of the participant's household has been randomized into the Elira 3 study.

• Participant is between 18 - 65 years of age inclusive.
• Participant has a BMI of 25 to \< 35 kg/ m2.
• Participant has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
• Participant is able to use a touch screen handheld smart phone.
• Participant has Wi-Fi internet access for the duration of the study.
• Participant is fluent in English or Spanish and can complete questionnaires.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening and enrollment visit and agree to using birth control to avoid pregnancy during the trial, prior to placement of assigned treatment device.
• Participant agrees to adhere to diet \& exercise recommendations throughout study duration.
• Participant is willing and able to adhere to assigned therapy throughout the study duration.
• Participant has not participated in any clinical trial (except a registry) within the last 30 days.-