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NCT06744933Not yet recruiting

Auricular Acupressure Integrated With a Smartphone Application for Weight Reduction

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
17 Dec 2024
Start date
9 Apr 2025
Primary completion date
31 Dec 2026
Lead sponsor
Tung Wah College
Diseases
Obesity
NCT number
NCT06744933

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 9 Apr 2025 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • has drug-induced obesity;
  • is planning to have weight-reduction treatment(s) (such as medications targeted for weight reduction, and bariatric surgery) in the coming 6 months.
  • 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)

Other illness

  • has any eating disorder (screened by the 5-item SCOFF questionnaire);
  • has cognitive impairment (Abbreviated Mental Test (Hong Kong version), AMT score below 6 (less than or equal to 5) will be excluded.);
  • has cancer; or

Other

  • is pregnant;
  • has a severe body disability, such as hemiplegia, that may prevent following instructions to use the smartphone.

Who the study is looking for

  • age ≥ 18 years;
  • 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;
  • 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);
  • are taking medications and receiving follow-up medical consultation \[Note: With the consent of the participants, the researchers (i.e., the RCA and the RA) will verify relevant medical records in the follow-up appointments\];
  • taken no weight control measures in the past 6 months;
  • has no trauma, inflammation or pathological lesion on ears;
  • is a smartphone user.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Risk Assessment & Management Clinic, Tsan Yuk Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Sai Ying Pun Jockey Club General Out-patient Clinic
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.