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

Trial Summary

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 data supports the effectiveness of the ObeEnd Weight Loss Wristband treatment for obesity?

Research shows that technology-based interventions, like wearable devices, can help with weight loss when they include features like self-monitoring and personalized feedback. Additionally, a study found that using a non-invasive device to change eating behavior led to significant weight loss in obese individuals. ^{1 2 3 4 5}

Is the ObeEnd Device for Obesity safe for humans?

There is no specific safety data available for the ObeEnd Device for Obesity in the provided research articles. ^{6 7 8 9 10}

How is the ObeEnd Weight Loss Wristband treatment different from other obesity treatments?

The ObeEnd Weight Loss Wristband is unique because it is a wearable device designed to aid weight loss, potentially offering a non-invasive and convenient alternative to traditional methods like diet and exercise programs or medication. Unlike other treatments, it may focus on altering behavior through real-time feedback and monitoring, similar to other wearable technology used in weight management. ^{1 2 3 4 11}

What is the purpose of this trial?

n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss. To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.

Research Team

Sylvia Santosa, PhD, RD

Principal Investigator

Concordia University, Montreal

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

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]

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]

References

1. United States 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. [2018]

2. England 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. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

OBINTER: A Holistic Approach to Catalyse the Self-Management of Chronic Obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A digital health weight-loss intervention in severe obesity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Technology-based interventions in the treatment of overweight and obesity: A systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. [2018]

7. Netherlands 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Validity of armband measuring energy expenditure in overweight and obese children. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Wearable Devices Beyond Activity Trackers in Youth with Obesity: Summary of Options. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. [2022]