Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4B1R6
- School of Health, Concordia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI >30 kg/m2
- no history of chronic illness or disease
- premenopausal
Exclusion Criteria:
- pregnant, breastfeeding
- medications that may affect outcomes
- chronic disease or conditions that may affect outcomes
- smoking or use of nicotine containing products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Band
Participants in this group will receive an active band which provides electrostimulation at PC6
|
The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
|
|
Placebo Comparator: Placebo
Participants in this group will receive an inactive band which does not provide any electrostimulation when turned on.
|
The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
after 2 weeks of wearing the band
|
|
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.
|
after 2 weeks of wearing the band
|
|
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".
|
after 2 weeks of wearing the band
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sylvia Santosa, PhD, RD, Concordia University, Montreal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30015228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.