Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite

Not Applicable

Completed

• Conditions: Healthy Obesity, Metabolically; Obesity
• Interventions: Device: ObeEnd Band; Other: Placebo

• Registration Number: NCT06411483
• Lead Sponsor: Concordia University, Montreal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2024-03-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-13
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Band	ObeEnd Band	Participants in this group will receive an active band which provides electrostimulation at PC6
Placebo	Placebo	Participants in this group will receive an inactive band which does not provide any electrostimulation when turned on.

Primary Outcome Measures

Name	Time	Method
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.
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".

Trial Locations

Locations (1)

School of Health, Concordia University; 🇨🇦 Montréal, Quebec, Canada