Safety & Effectiveness of TENS Weight Management Compared to a Sham

Inclusion Criteria:

1. Participant is between 18 - 65 years of age inclusive.

2. Participant has a BMI of 25 to < 35 kg/ m2.

3. Participant has signed the informed consent form and is able to comply with studyprotocol and adhere to study visit schedule.

4. Participant is able to use a touch screen handheld smart phone.

5. Participant has Wi-Fi internet access for the duration of the study.

6. Participant is fluent in English or Spanish and can complete questionnaires.

7. Females of childbearing potential (FOCBP) must have a negative urine pregnancy testat screening and enrollment visit and agree to using birth control to avoidpregnancy during the trial, prior to placement of assigned treatment device.

8. Participant agrees to adhere to diet & exercise recommendations throughout studyduration.

9. Participant is willing and able to adhere to assigned therapy throughout the studyduration.

10. Participant has not participated in any clinical trial (except a registry) withinthe last 30 days.-

Exclusion Criteria:

1. Participant has any known gastrointestinal disorder that in the opinion of theInvestigator precludes enrollment into the trial.

2. Participant has had a prior bariatric surgical procedure, endoscopic bariatrictherapy, or surgery on the stomach.

3. Participant has any significant multisystem disease in the opinion of theInvestigator.

4. Participant is a Type 2 diabetic.

5. Participant has a history of significant cardiac arrhythmia, ectopy, or significantcardiovascular disease.

6. Participant has an existing implanted electrical stimulator (e.g., pacemaker, AICD,cochlear implant).

7. For female participants: planned pregnancy within 6 months from study start, activepregnancy, or currently breast feeding.

8. Participant has current and/or a history of cancer with the exception ofnon-melanoma skin cancer or cervical carcinoma in situ < 3 years before studyenrollment.

9. Participant has had a weight change of ± 5% of his/her Total Body Weight in the 3months prior to screening.

10. Participant has an uncontrolled psychiatric disorder.

11. Participant has a diagnosed neurological disease.

12. Participant has a skin disorder affecting the thoracic dermatomes.

13. Participant has active/has ever had shingles in the abdominal area.

14. Participant has abdominal surgery or other scars which may interfere with TENSstimulation in the opinion of the PI.

15. Participant has known allergic reaction to materials in the TENS electrodes and/oris otherwise unable to tolerate stimulation with the wearable TENS system. Thisincludes known allergies or sensitivity to latex, nickel and/or hydrogels.

16. Participant has a history of sensitive skin, including eczema wheel-and-flare orother skin irritation, per PI discretion.

17. Participant is actively participating or unwilling to discontinue participation inanother weight loss program. (Participants may not enroll in paid or unpaid programsthat involve inperson or online coaching during the course of the Elira study.)

18. Participant has a history of eating disorders (Bulimia, Binge Eating, Night EatingSyndrome, Compulsive Overeating) and/or screens positive for Binge Eating asmeasured by the Binge Eating Score (BES) Questionnaire.

19. Participant has taken weight loss medications including but not limited to OTCmedications or any other medication known to cause weight loss or weight gain withinthe 2 months prior to enrollment.

20. Participant is planning any major medical treatments or surgeries that could causeweight loss during the study.

21. Participant works night shift or rotating night shifts that impact scheduleddaylight mealtimes.

22. Inability to walk at least 0.8 kilometers per day (10 minutes of continuouswalking).

23. Current smoker or user of nicotine product or smoking cessation within 1 year of thescreening date.

24. History of treatment for or current abuse of drugs or alcohol.

25. A score of 10 or higher on the Patient Health Questionnaire 9 (PHQ-9), demonstratingmoderate depression.

26. Any participant that the Investigator considers inappropriate for the study formedical reasons.

27. Participant is taking Topiramate, Adderall, or Ritalin within the 6 months prior toenrollment.

28. Participant is on drug therapy which may alter antral motility or appetite, perInvestigator discretion within the 2 months prior to enrollment.

29. History of cirrhosis or pancreatitis.

30. History of COPD or other pulmonary disease that restricts exercise tolerance.

31. Immunocompromised due to medications or disease or HIV positive.

32. History of severe Covid-19 symptoms requiring hospitalization or history of Covid-19infection with unresolved symptoms.

33. TSH levels > 10mU/L or < 0.1 mU/L.

34. Prior participation in an Elira sponsored study.

35. A current member of the participant's household has been randomized into the Elira 3study.