ObeEnd Device for Obesity

Overseen By Sylvia Santosa, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Concordia University, Montreal

Must not be taking: Hormone therapy

Disqualifiers: Nicotine use, Chronic disease, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 1 hour

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called ObeEnd, which uses gentle electrical pulses to control appetite by stimulating a specific point on the wrist. Researchers aim to assist weight loss by adjusting appetite hormones and improving stomach function. The trial will compare the effects of the ObeEnd device to a non-functional version to determine its effectiveness. Suitable participants are generally healthy, premenopausal women with obesity who have not recently used nicotine and do not have chronic diseases. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new weight loss solutions.

Will I have to stop taking my current medications?

The trial requires that you do not use any medications that may affect the study outcomes, such as hormone replacement therapy. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that the ObeEnd device is safe for weight control?

Research shows that the ObeEnd device aids weight management by sending gentle electrical pulses to a specific spot on the wrist, known as PC6. This spot might help control appetite by influencing hormones and enzymes related to hunger. Although specific safety information for the ObeEnd device is unavailable, similar devices provide helpful insights.

The ObeEnd device does not use drugs, often resulting in fewer side effects compared to medications. Studies have shown that similar devices can effectively reduce appetite and food intake. Users of these devices have reported positive weight loss results with little discomfort.

The trial is marked as "Not Applicable" in terms of phases, indicating that the device might be in early testing or does not require the usual phased trials. This means detailed safety information might not be available yet, but the device's non-invasive nature generally suggests a lower risk.

In summary, the ObeEnd device aims to assist with weight loss by controlling appetite through wrist stimulation. While specific safety data is limited, its non-drug approach and focus on appetite control suggest it is likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for obesity, like medications or surgery, focus on reducing appetite or altering digestion. But the ObeEnd Device stands out because it uses a novel approach: a functional band that is applied externally to influence body signals related to hunger and satiety. This non-invasive method avoids the need for medication or invasive procedures, reducing potential side effects and recovery time. Researchers are excited because it offers a fresh way to manage obesity, potentially providing a safer, quicker alternative to existing options.

What evidence suggests that the ObeEnd device is effective for obesity?

Research has shown that the ObeEnd device, which trial participants may receive as a functional band, may aid weight loss by reducing hunger and altering stomach function. Studies have found that people using a similar device lost about 11% of their weight over time. ObeEnd operates by sending gentle electrical signals to a spot on the wrist called PC6, which may help control hunger and reduce stomach activity. Clinical studies also indicate that ObeEnd can lead to consuming fewer calories. These findings suggest that the ObeEnd device could be a useful tool for managing obesity. ^{1 2 3 5 6}

Who Is on the Research Team?

Sylvia Santosa, PhD, RD

Principal Investigator

Concordia University, Montreal

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or obese. Participants should be interested in testing a new device designed to control appetite through electrical stimulation of an acupressure point on the wrist. Specific eligibility criteria were not provided.

Inclusion Criteria

Generally healthy

I am a woman who has not gone through menopause.

My BMI is over 30.

Exclusion Criteria

I am not pregnant, less than 6 months postpartum, or breastfeeding.

Past (<1 year) or present use of nicotine products

I do not have liver disease, kidney problems, or untreated thyroid issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo acute electrostimulation of PC6 for a 1 hour period to measure changes in appetite hormones and enzymes

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for changes in appetite and blood hormone levels post-treatment

4 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ObeEnd

Trial Overview

The study tests the ObeEnd device, which aims to reduce appetite and aid weight loss by stimulating an acupuncture point with electrical pulses. The effect on appetite hormones will be compared between a functional band and a placebo band over a one-hour period.

How Is the Trial Designed?

Group I: Functional band Active Control 1 Intervention

Group II: Nonfunctional band Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Concordia University, Montreal

Lead Sponsor

Trials

30

Recruited

5,200+

Published Research Related to This Trial

The SenseWear Pro2 Armband (SWA) with software version 5.1 accurately measures energy expenditure in free-living overweight and obese children, showing no significant difference compared to the doubly labeled water (DLW) method over a 14-day period with 22 participants.

In contrast, using software version 6.1 resulted in a significant underestimation of energy expenditure by 18%, indicating that the choice of software is crucial for accurate assessments in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of armband measuring energy expenditure in overweight and obese children. Catharina Bäcklund, ., Gunnevi Sundelin, ., Christel Larsson, .[2019]

A clinical trial involving 70 overweight or obese primary care patients will compare the effectiveness of a standard diet intervention alone versus one that includes a free smartphone app and wearable device for weight loss over 12 months.

The study aims to assess not only weight loss but also changes in physical activity and cardiometabolic risk factors, potentially demonstrating how technology can enhance traditional weight loss methods in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial. Granado-Font, E., Flores-Mateo, G., Sorlí-Aguilar, M., et al.[2018]

Participants in the SBWL+TECH group, who used a wearable physical activity monitor, increased their moderate-to-vigorous physical activity by 132.9 minutes per week, which was three times greater than the SBWL group, although this difference was not statistically significant.

Both groups experienced modest weight loss, with the SBWL+TECH group losing 10.0% of their body weight compared to 7.8% in the SBWL group, indicating that technology-assisted monitoring may help enhance physical activity levels in severely obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. Unick, JL., O'Leary, KC., Bond, DS., et al.[2022]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

The OBINTER platform is a comprehensive mobile application designed to support long-term weight loss by integrating personalized diet plans, activity tracking, and adherence strategies, addressing multiple factors that contribute to successful weight management.

Usability testing of the OBINTER platform showed positive results, indicating that it effectively engages users in their weight loss journey and helps them manage their obesity more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OBINTER: A Holistic Approach to Catalyse the Self-Management of Chronic Obesity. Álvarez, R., Torres, J., Artola, G., et al.[2021]

A total of 4941 adverse event (AE) reports were identified for antiobesity medicines in Europe from 2007 to 2014, with over 90% classified as serious, including 159 deaths, highlighting significant safety concerns associated with these medications.

The most commonly reported serious AEs were cardiac (19%) and psychiatric disorders (18%), particularly linked to orlistat and rimonabant, indicating a need for ongoing safety monitoring despite the withdrawal of some products from the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Aagaard, L., Hallgreen, CE., Hansen, EH.[2018]

In a study of 8275 obese individuals (BMI ≥35 kg/m²), a remote weight-loss program using a mobile app, wireless scales, and meal replacements led to significant weight loss, with an average of 8.1 kg lost after 42 days and 14 kg after 120 days.

The program was effective for both men and women, with over 73% of participants losing more than 5% of their body weight, indicating that this approach can be a viable intervention for severe obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital health weight-loss intervention in severe obesity. Senecal, C., Collazo-Clavell, M., Larrabee, BR., et al.[2022]

Diet and exercise alone have not proven effective for sustained weight loss in most obese individuals, while surgical interventions can lead to prolonged weight loss but may result in rebound weight gain over time.

The authors propose a new framework for evaluating medical devices aimed at treating obesity, focusing on a benefit-risk assessment to guide the development and approval of these devices, which was discussed at an FDA workshop and advisory panel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. Lerner, H., Whang, J., Nipper, R.[2021]

Wearable technologies beyond just physical activity trackers can provide valuable biofeedback on various health metrics, such as glycemic variability and sleep, which may enhance adherence to obesity treatment protocols in children and adolescents.

The review of 15 studies involving participants aged 6-21 years indicates that these wearable devices are safe and have high adherence rates, suggesting they can be effectively integrated into pediatric obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Devices Beyond Activity Trackers in Youth with Obesity: Summary of Options. Chimatapu, SN., Mittelman, SD., Habib, M., et al.[2023]

Technology-based interventions for weight loss, particularly those incorporating multiple key components like self-monitoring and counselor feedback, can lead to significant weight loss compared to standard care, as shown in 13 out of 27 reviewed trials.

However, there is currently no evidence that these interventions improve quality of life, and more research is needed to determine the best ways to use technology effectively in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based interventions in the treatment of overweight and obesity: A systematic review. Raaijmakers, LC., Pouwels, S., Berghuis, KA., et al.[2022]

A novel non-invasive intra-oral medical device was tested on 6 obese patients, leading to a significant average weight loss of 11% over a follow-up period of 23 months, with no reported complications from the device.

All participants continued to lose weight after the initial 4 to 8 weeks of using the device, and none experienced weight regain, suggesting that this method effectively promotes sustained weight loss in individuals with a history of unsuccessful dieting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent weight loss with a non-invasive novel medical device to change eating behaviour in obese individuals with high-risk cardiovascular risk profile. von Seck, P., Sander, FM., Lanzendorf, L., et al.[2018]

Citations

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ObeEnd

ObeEnd is a smart wristband designed to combat the obesity epidemic. It controls caloric intake by reducing appetite, gastric secretion, and gastric ...

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ObeEnd Device for Obesity

A novel non-invasive intra-oral medical device was tested on 6 obese patients, leading to a significant average weight loss of 11% over a follow-up period of 23 ...

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ObeEnd generates targeted electric stimulation to PC6, which helps reduce hunger and appetite by reducing gastric secretion signals from the brain. ObeEnd's ...

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Study Details | NCT06411483 | Determining the ...

This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the ...

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prnewswire.com/news-releases/obeend---pioneering-drug-free-weight-management-wristband-302143248.html

Pioneering Drug-Free Weight Management Wristband

Clinical studies have demonstrated that ObeEnd results in significant reduction in caloric intake and pepsinogen-1 production. The mechanism ...

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ObeEnd - Weight loss wristband

His weight dropped by 8 pounds, and the effect was remarkable. Based on the differences of each individual, ObeEnd can help weight loss people achieve the ...