Auricular Acupressure Integrated With a Smartphone Application for Weight Reduction

April 7, 2025 updated by: Tung Wah College

Self-administered Auricular Acupressure Integrated With a Smartphone Application for Weight Reduction in Patients With Obesity Accompanied With Obesity-related Comorbid Illness: A Randomised Controlled Clinical Trial

The goal of this clinical trial is to learn whether self-administered auricular acupressure integrated with a smartphone application works to reduce weight in patients with obesity accompanied with obesity-related comorbid illness. The main questions it aims to answer are:

  • Is there significant difference in the Body Mass Index (BMI) between the self-administered auricular acupressure integrated with a smartphone app (Version 2) group (experimental group) and the usual care group, in people with obesity accompanied with metabolic syndrome?
  • Are there significant differences in other anthropometric parameters between the two groups? These parameters include waist circumference, body fat percentage, skeletal muscle percentage, and waist-to-hip ratio.
  • Are there any significant differences in obesity-related parameters between the two groups? These parameters include blood lipid profile (triglyceride, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)), blood glucose concentrations (fasting glucose and glycated haemoglobin/ HbA1c), and blood pressure.

Participants in the experimental group will:

  • Be affixed with 6 to 8 hypoallergic Vaccariae Semen ear patches on one ear each time
  • Visit the clinic twice a week to change a new set of ear patches on the opposite ear
  • Will undergo this intervention for 8 weeks
  • Install a smartphone application which will send pop-up notifications to remind them to press on the ear patches regularly every day
  • Keep a record on the number of times pressing on the smartphone application

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity has become a global public health problem, and its prevalence is surging in Asia. According to the Population Health Survey in 2020-22 by the Department of Health in Hong Kong, over 50% of Hong Kong general population was classified as obese (Body Mass Index (BMI) ≥ 25.0 kg/m2) or overweight (BMI ≥ 23.0 kg/m2), and central obesity was accounting for 37.8%. As the population ages, overweight and obesity become more and more serious. The incidence of metabolic syndrome is increasing yearly around the world. According to the health survey mentioned above, the prevalence of various disorders that constitute metabolic syndrome ranged from 8.5% (hyperglycaemia or diabetes) to 51.9% (raised blood cholesterol or hypercholesterolaemia). Metabolic syndrome is a collective disorder comprising abdominal obesity, abnormal blood sugar, dyslipidaemia and hypertension, which seriously affects the health of the body and cannot be ignored.

Western medications currently used for weight reduction include centrally-acting appetite suppressants, blockers inhibiting intestinal fat absorption, and metabolic stimulants. Although these Western medications are effective in treating obesity, the associated adverse effects limit their clinical applications. Long-term use of weight reduction medications can cause many adverse effects in the cardiovascular system, digestive system, and liver. Bariatric surgery, such as gastric bypass or sleeve gastrectomy, may cause serious complications, for instance, bleeding, intestinal obstruction, anorexia, or gastric perforation.

In recent years, mobile health (mHealth) has played an essential role in preventing and managing chronic diseases. In the fields of both medicine and nursing care, smartphone apps are widely used to assist in the intervention of chronic diseases. A smartphone app can remind participants to press the ear patches promptly and correctly to achieve optimum treatment effect. In addition, the smartphone app can also provide relevant health information to encourage people with obesity to change their unhealthy lifestyles.

Through literature review and expert consultation, the research team selected six auricular acupoints that were found to have specific effects on weight reduction, namely Shenmen, Stomach, Endocrine, External nose (also known as "hunger point"), Large intestine, and Forehead. Not only does the smartphone app remind the participants to press on the auricular acupoints, the participants can also learn about the benefits of auricular acupressure, the locations of auricular acupoints, and the correct way of executing auricular acupressure on the smartphone app.

This proposed research project aims to evaluate the efficacy of self-administered auricular acupressure integrated with a smartphone app (Version 2), a composite intervention for people with obesity accompanied with metabolic syndrome. It will be a two-arm randomised clinical trial conducted in a community setting.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lorna Kwai Ping Suen, BN, MPH, PhD
  • Phone Number: (852) 3725 6228
  • Email: lornasuen@twc.edu.hk

Study Contact Backup

  • Name: Chun Kin Mak, Bachelor of Chinese Medicine
  • Phone Number: (852) 37256194
  • Email: dickymak@twc.edu.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Sai Ying Pun Jockey Club General Out-patient Clinic
        • Contact:
        • Contact:
          • Dr. Welchie Wai Kit KO
          • Phone Number: (852) 25892339
          • Email: kowk@ha.org.hk
        • Contact:
          • Dr. Welchie Wai Kit KO
      • Hong Kong, Hong Kong
        • Risk Assessment & Management Clinic, Tsan Yuk Hospital
        • Contact:
        • Contact:
          • Dr. Welchie Wai Kit KO
          • Phone Number: (852) 25892339
          • Email: kowk@ha.org.hk
        • Contact:
          • Dr. Jenny Hua Li WANG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age ≥ 18 years;
  2. Body Mass Index (BMI) ≥ 30 kg/m2 and /or abdominal obesity (i.e., central obesity), that is, male waist circumference ≥ 90cm while female waist circumference ≥ 80cm;
  3. fulfils diagnostic criteria for metabolic syndrome with any two or more of the following: (a) blood pressure ≥ 130/85 mmHg and/ or confirmed diagnosis of hypertension with treatment; (b) fasting blood glucose ≥ 100 mg/dl (5.6 mmol/L) and/ or confirmed diagnosis of diabetes with treatment; (c) fasting triglyceride ≥ 150 mg/dl (1.7 mmol/L) and/ or received specific treatment on dyslipidaemia; (d) fasting high-density lipoprotein (HDL) < 40mg/dl (< 1.03mmol/L) in male; < 50mg/dl (< 1.29 mmol/L) and/ or received specific treatment on dyslipidaemia; These standards are based on the diagnostic criteria for metabolic syndrome from the World Health Organisation (1999), the International Diabetes Federation Criteria (2005), and the Chinese Diabetes Society (2000);
  4. are taking medications and receiving follow-up medical consultation [Note: With the consent of the participants, the researchers (i.e., the RCA and the RA) will verify relevant medical records in the follow-up appointments];
  5. taken no weight control measures in the past 6 months;
  6. has no trauma, inflammation or pathological lesion on ears;
  7. is a smartphone user.

Exclusion Criteria:

  1. has any eating disorder (screened by the 5-item SCOFF questionnaire);
  2. has drug-induced obesity;
  3. is pregnant;
  4. has cognitive impairment (Abbreviated Mental Test (Hong Kong version), AMT score below 6 (less than or equal to 5) will be excluded.);
  5. has cancer; or
  6. has a severe body disability, such as hemiplegia, that may prevent following instructions to use the smartphone.
  7. is planning to have weight-reduction treatment(s) (such as medications targeted for weight reduction, and bariatric surgery) in the coming 6 months.

  8. is taking the following medications that potentially affect the body weight:

    • Corticosteroids (e.g., prednisone and dexamethasone)
    • Second generation antipsychotics (e.g., olanzapine, clozapine, quetiapine and risperidone)
    • Levothyroxine
    • FDA-approved medications for obesity or weight loss (e.g., phentermine, diethylpropion, phendimetrazine, phentermine + topiramate extended release (ER), naltrexone + bupropion ER, orlistat, liraglutide, semaglutide and GLP-1 (liraglutide/ semaglutide) + tirzepatide)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-administered auricular acupressure integrated with a smartphone application
Patients in this group will undergo TCM syndrome differentiation, and then be given 6 to 8 hypoallergic Vaccariae Semen ear patches on one ear. 6 of the auricular acupoints will be compulsory, while the additional 1 to 2 acupoints will be selected according to the TCM syndrome of the patient. These 6 mandatory acupoints were selected according to previous literature and expert opinion. The research staff will use an ear model to demonstrate to the patients how to press on the auricular acupoints and require them to perform a return demonstration to ensure they can perform auricular acupressure correctly by themselves. The patient will then be required to visit the clinic twice a week and will change a new set of ear patches on the same acupoints of the opposite ear. This intervention will last for 8 weeks. Their BMI (and weight) and their satiety level will be monitored once a week while they visit the clinic.
Combination product: Self-administered auricular acupressure integrated with a smartphone application
6 to 8 Vaccariae Semen ear patches will be affixed on one ear of the patient. The patient will be required to press on the ear patches 3 times a day, and 30 minutes before a meal. Every 3 to 4 days, the patient will visit the clinic to change a new set of ear patches on the same auricular acupoints of the opposite ear alternately. The whole course of intervention will be 8 weeks. The smartphone app will send scheduled pop-up notifications to remind patients to press on the ear patches. The patient will be required to enter the number of times pressing and of defaecation every day on the smartphone application. The smartphone application will send more notifications to the patient if he/ she has a low compliance. When the participants record the number of times pressing on the auricular acupoints, positive reinforcement messages will pop-up, such as "Excellent job!" for those with good compliance while "You are almost there! Keep going!" for those with poor compliance.
No Intervention: Usual care
The usual care group will receive no intervention. They will only be assessed on the outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline in the mean Body Mass Index (BMI) at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
BMI is a continuous numerical scale. Zero is equivalent to no change in weight; Positive change is equivalent to weight gain; Negative change is equivalent to weight reduction.
Baseline, one month post-intervention, and four months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean waist circumference at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
Waist circumference is continuous numerical scale. Waist circumference will be measured midway between the edge of the lower ribs and the iliac crest. To ensure accuracy, each measurement will be taken twice and the average will be calculated. Zero is equivalent to no change. Broadly speaking, positive changes refer to unhealthy change and negative changes refer to healthy change.
Baseline, one month post-intervention, and four months post-intervention
Changes from baseline in mean body fat percentage and skeletal muscle percentage at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
They are all continuous numerical scales with reference ranges indicating a healthy state. Any value outside these reference ranges can be regarded as unhealthy. Body fat percentage and skeletal muscle percentage will be measured by Tanita BC-545N. For both of them, zero is equivalent to no change. Broadly speaking, for body fat percentage, positive changes refer to unhealthy change and negative changes refer to healthy change. Alternatively, for skeletal muscle percentage, positive change refers to healthy change and negative change refers to unhealthy change.
Baseline, one month post-intervention, and four months post-intervention
Change from baseline in mean waist-to-hip ratio at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
Waist-to-hip ratio is all continuous numerical scale. Waist and hip circumferences will be measured by hand. Zero is equivalent to no change. Positive change refers to a more apple-shaped body shape and negative change refers to a more pear-shaped body shape.
Baseline, one month post-intervention, and four months post-intervention
Changes from the baseline in the mean blood lipid profile at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
Blood lipid profile include triglyceride , total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL).They are all continuous numerical scales with reference ranges indicating a healthy state. Any value outside these reference ranges can be regarded as unhealthy. Zero is equivalent to no change. These parameters mainly measure the changes in patients with dyslipidaemia. As a result, positive changes in triglyceride, total cholesterol and LDL refer to unhealthy change and negative changes refer to healthy change. Positive change in HDL refers to healthy change and negative change refers to unhealthy change.
Baseline, one month post-intervention, and four months post-intervention
Changes from the baseline in the mean blood glucose concentrations at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
Blood glucose concentrations include fasting glucose and glycated haemoglobin/ HbA1c. They are all continuous numerical scales with reference ranges indicating a healthy state. Any value outside these reference ranges can be regarded as unhealthy. Zero is equivalent to no change. These parameters mainly measure changes in patients with diabetes. As a result, positive changes in fasting glucose and HbA1c refer to unhealthy change and negative changes refer to healthy change.
Baseline, one month post-intervention, and four months post-intervention
Change from the baseline in the mean blood pressure at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
Blood pressure is a continuous numerical scale. It mainly measures changes in patients with hypertension. As a result, positive changes in blood pressure (systolic and diastolic) refer to unhealthy change and negative changes refer to healthy change.
Baseline, one month post-intervention, and four months post-intervention
Differences in the change from baseline in BMI (and other parameters in the secondary outcomes) in patients in the experimental group with different TCM syndromes at one month and four months after the completion of the intervention
Time Frame: Baseline, one month post-intervention, and four months post-intervention
TCM syndrome differentiation will be performed in patients in the experimental group. They will be classified into "Excessive", "Deficient", or "Deficiency-Excess Complex". Possible sub-classification may be performed. The changes in all outcome parameters (including primary and secondary outcomes) mentioned above will be compared across patients with different syndromes. Any significant difference detected among these syndromes may indicate positive or negative effect on a specific TCM syndrome type(s).
Baseline, one month post-intervention, and four months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tung Wah College

Collaborators

Hospital Authority Hong Kong West Cluster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 9, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04-75-CMDF240401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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