Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT06744933
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06744933
Study Brief:
Protocol Section:
NCT06744933