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

NCT06411483 | Completed

• 1 other identifier: 30015228
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Obesity, Metabolically; Obesity

Keywords

acupuncture; obesity; appetite; weight

Outcome Measures

Primary Outcomes (3)

• 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.

  after 2 weeks of wearing the band

• Dietary assessment

  Changes in dietary intake will be measured through 3 day food records combined with photos.

  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".

  after 2 weeks of wearing the band

Study Arms (2)

Active Band

ACTIVE COMPARATOR

Participants in this group will receive an active band which provides electrostimulation at PC6

Device: ObeEnd Band

Placebo

PLACEBO COMPARATOR

Participants in this group will receive an inactive band which does not provide any electrostimulation when turned on.

Other: Placebo

Interventions

ObeEnd Band DEVICE

The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Active Band

Placebo OTHER

The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>30 kg/m2
• no history of chronic illness or disease
• premenopausal

You may not qualify if:

• pregnant, breastfeeding
• medications that may affect outcomes
• chronic disease or conditions that may affect outcomes
• smoking or use of nicotine containing products

Sponsors & Collaborators

• Concordia University, Montreal: lead

Study Sites (1)

School of Health, Concordia University

Montreal, Quebec, H4B1R6, Canada

Location

MeSH Terms

Conditions

Obesity, Metabolically Benign; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvia Santosa, PhD, RD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized to receive active or placebo (inactive) bands.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An active device arm will be compared to an inactive device (placebo) arm

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
• Access Criteria: On request with ethics approval.

Locations

CA (1)