Clinical trial

Auricular Acupressure Integrated With a Smartphone Application for Weight Reduction

Opening soon · Not applicable · 1 countries · Registry ID NCT06744933

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity and Metabolic Syndrome

Full registry criteria

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)

Treatments and study arms

Self-administered auricular acupressure integrated with a smartphone application

Combination Product

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.

Primary outcomes

Change from the baseline in the mean Body Mass Index (BMI) at one month and four months after the completion of the interventionBaseline, 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.