Healthy Obesity, MetabolicallyNCT06411483
Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite
A study testing ObeEnd Band in people with Healthy Obesity, Metabolically and Obesity, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
In 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Obesity, Metabolically, Obesity
- What is being tested?
- ObeEnd Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >30 kg/m2
- no history of chronic illness or disease
- premenopausal
Who cannot join
- pregnant, breastfeeding
- medications that may affect outcomes
- chronic disease or conditions that may affect outcomes
- smoking or use of nicotine containing products
Trial locations and contacts
1 site in 1 country.
About this study
In 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, electrostimulation of PC6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. The investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.
- Conditions
- Healthy Obesity, Metabolically, Obesity
- Being tested
- ObeEnd Band, Placebo
- Keywords
- acupuncture, obesity, appetite, weight
- Medical subject headings
- Obesity, Metabolically Benign, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeEnd BandDevice
The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
PlaceboOther
The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active Band | Active comparator | Participants in this group will receive an active band which provides electrostimulation at PC6 Receives: Device: ObeEnd Band |
| Placebo | Placebo comparator | Participants in this group will receive an inactive band which does not provide any electrostimulation when turned on. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors involved with appetite regulation
Blood hormones and proteins involved with appetite regulation. Appetite will be assessed via the Adult Eating Behaviour Questionnaire to see changes from baseline. This is a 35-item questionnaire that assesses 8 traits of appetite/hunger on a 1-5 Likert scale with a score of 1 indicating "strongly disagree" and a score of 5 indicating "strongly agree" to the statement.
Measured: after 2 weeks of wearing the band
Dietary assessment
Changes in dietary intake will be measured through 3 day food records combined with photos.
Measured: after 2 weeks of wearing the band
Physical activity
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) to see changes from baseline. The questionnaire measures various dimensions of physical activity over a 7 day retrospective period. The questions are open ended, asking participants to fill out a number for the time period being asked. For example, "___days per week".
Measured: after 2 weeks of wearing the band
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Obesity, MetabolicallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An active device arm will be compared to an inactive device (placebo) arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Santosa, Concordia University, Montreal
- Investigators
- Sylvia Santosa, PhD, RD, Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411483
- Sponsor's protocol ID
- 30015228
- Status last verified
- May 2024
- First submitted
- 26 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request and approval by ethics
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite
- ClinicalTrials.gov ID
- NCT06411483
- Acronym / sponsor ID
- 30015228
- Conditions
- Healthy Obesity, Metabolically, Obesity
- Keywords
- acupuncture, obesity, appetite, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 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, electrostimulation of PC6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. The investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An active device arm will be compared to an inactive device (placebo) arm
| Arm | Type | Receives |
|---|---|---|
| Active Band | Active comparator | Device: ObeEnd BandParticipants in this group will receive an active band which provides electrostimulation at PC6 |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this group will receive an inactive band which does not provide any electrostimulation when turned on. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >30 kg/m2
- no history of chronic illness or disease
- premenopausal
Key exclusion criteria (4 listed)
- pregnant, breastfeeding
- medications that may affect outcomes
- chronic disease or conditions that may affect outcomes
- smoking or use of nicotine containing products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObeEnd BandThe ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes. | Device | Active Band |
| PlaceboThe nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes. | Other | Placebo |
Primary outcome
Factors involved with appetite regulation
Time frame: after 2 weeks of wearing the band
Blood hormones and proteins involved with appetite regulation. Appetite will be assessed via the Adult Eating Behaviour Questionnaire to see changes from baseline. This is a 35-item questionnaire that assesses 8 traits of appetite/hunger on a 1-5 Likert scale with a score of 1 indicating "strongly disagree" and a score of 5 indicating "strongly agree" to the statement.
Dietary assessment
Time frame: after 2 weeks of wearing the band
Changes in dietary intake will be measured through 3 day food records combined with photos.
Physical activity
Time frame: after 2 weeks of wearing the band
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) to see changes from baseline. The questionnaire measures various dimensions of physical activity over a 7 day retrospective period. The questions are open ended, asking participants to fill out a number for the time period being asked. For example, "___days per week".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes. On request and approval by ethics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Santosa, PhD, RD principal investigator
Concordia University, Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ObeEnd Band in people with Healthy Obesity, Metabolically and Obesity, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors involved with appetite regulation (time frame: after 2 weeks of wearing the band). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.