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
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];
has any eating disorder (screened by the 5-item SCOFF questionnaire);
has drug-induced obesity;
is pregnant;
has cognitive impairment (Abbreviated Mental Test (Hong Kong version), AMT score below 6 (less than or equal to 5) will be excluded.);
Parallel
Self-administered auricular acupressure integrated with a smartphone application
Combination product6 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.
Change from the baseline in the mean Body Mass Index (BMI) at one month and four months after the completion of the 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.
Change from baseline in mean waist circumference at one month and four months after the completion of the 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.
Changes from baseline in mean body fat percentage and skeletal muscle percentage at one month and four months after the completion of the 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.
Change from baseline in mean waist-to-hip ratio at one month and four months after the completion of the 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.
Changes from the baseline in the mean blood lipid profile at one month and four months after the completion of the 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.
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Tung Wah College
Lead sponsor
Hospital Authority Hong Kong West Cluster
Collaborator
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