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OpenTrials
Completed

NCT Number: NCT06411483

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.

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Key information

Conditions

Healthy Obesity, Metabolically Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Metabolically Benign Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health, Concordia University

Montreal, Quebec, H4B1R6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ObeEnd Band

Device

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

Placebo

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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".

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 13, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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