Healthy Obesity, Metabolically, Obesity
Conditions
Keywords
acupuncture, obesity, appetite, weight
Brief 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. 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.
Interventions
DEVICEObeEnd Band
The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
OTHERPlacebo
The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.
Sponsors
Concordia University, Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be randomized to receive active or placebo (inactive) bands.
Intervention model description
An active device arm will be compared to an inactive device (placebo) arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 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. |
| Factors involved with appetite regulation | 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 | after 2 weeks of wearing the band | Changes in dietary intake will be measured through 3 day food records combined with photos. |
Countries
Canada
Outcome results
None listed