Auricular Acupressure Integrated With a Smartphone Application for Weight Reduction

NCT06744933 | Not Yet Recruiting

• 1 other identifier: 2024-04-75-CMDF240401
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity and Metabolic Syndrome

Keywords

auricular acupressure; auricular therapy; weight reduction; obesity; metabolic syndrome; mobile health; mHealth; smartphone application; traditional Chinese medicine; TCM; ear acupressure; weight loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, one month post-intervention, and four months post-intervention

Secondary Outcomes (7)

• Change from baseline in mean waist circumference at one month and four months after the completion of the intervention

  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

  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

  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

  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

  Baseline, one month post-intervention, and four months post-intervention

Study Arms (2)

Self-administered auricular acupressure integrated with a smartphone application

EXPERIMENTAL

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

Usual care

NO INTERVENTION

The usual care group will receive no intervention. They will only be assessed on the outcomes.

Interventions

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.

Self-administered auricular acupressure integrated with a smartphone application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tung Wah College: lead
• Hospital Authority Hong Kong West Cluster: collaborator

Study Sites (2)

Risk Assessment & Management Clinic, Tsan Yuk Hospital

Hong Kong, Hong Kong

Location

Sai Ying Pun Jockey Club General Out-patient Clinic

Hong Kong, Hong Kong

Location

Related Publications (12)

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  PMID: 36437105 BACKGROUND

• Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.

  PMID: 19445642 BACKGROUND

• Hsieh CH, Su TJ, Fang YW, Chou PH. Efficacy of two different materials used in auricular acupressure on weight reduction and abdominal obesity. Am J Chin Med. 2012;40(4):713-20. doi: 10.1142/S0192415X1250053X.

  PMID: 22809026 BACKGROUND

• Hsieh CH, Su TJ, Fang YW, Chou PH. Effects of auricular acupressure on weight reduction and abdominal obesity in Asian young adults: a randomized controlled trial. Am J Chin Med. 2011;39(3):433-40. doi: 10.1142/S0192415X11008932.

  PMID: 21598412 BACKGROUND

• Suen L, Wang W, Cheng KKY, Chua MCH, Yeung JWF, Koh WK, Yeung SKW, Ho JYS. Self-Administered Auricular Acupressure Integrated With a Smartphone App for Weight Reduction: Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2019 May 29;7(5):e14386. doi: 10.2196/14386.

  PMID: 31144666 BACKGROUND

• Granado-Font E, Flores-Mateo G, Sorli-Aguilar M, Montana-Carreras X, Ferre-Grau C, Barrera-Uriarte ML, Oriol-Colominas E, Rey-Renones C, Caules I, Satue-Gracia EM; OBSBIT Study Group. Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial. BMC Public Health. 2015 Jun 4;15:531. doi: 10.1186/s12889-015-1845-8.

  PMID: 26041131 BACKGROUND

• Eisenhauer CM, Hageman PA, Rowland S, Becker BJ, Barnason SA, Pullen CH. Acceptability of mHealth Technology for Self-Monitoring Eating and Activity among Rural Men. Public Health Nurs. 2017 Mar;34(2):138-146. doi: 10.1111/phn.12297. Epub 2016 Oct 18.

  PMID: 27757986 BACKGROUND

• Semper HM, Povey R, Clark-Carter D. A systematic review of the effectiveness of smartphone applications that encourage dietary self-regulatory strategies for weight loss in overweight and obese adults. Obes Rev. 2016 Sep;17(9):895-906. doi: 10.1111/obr.12428. Epub 2016 May 18.

  PMID: 27192162 BACKGROUND

• Lim R, Beekley A, Johnson DC, Davis KA. Early and late complications of bariatric operation. Trauma Surg Acute Care Open. 2018 Oct 9;3(1):e000219. doi: 10.1136/tsaco-2018-000219. eCollection 2018.

  PMID: 30402562 BACKGROUND

• Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014 Mar;149(3):275-87. doi: 10.1001/jamasurg.2013.3654.

  PMID: 24352617 BACKGROUND

• Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new developments in diet, physical activity, and behavior therapy. Circulation. 2012 Mar 6;125(9):1157-70. doi: 10.1161/CIRCULATIONAHA.111.039453. No abstract available.

  PMID: 22392863 BACKGROUND

• Ko GT. The cost of obesity in Hong Kong. Obes Rev. 2008 Mar;9 Suppl 1:74-7. doi: 10.1111/j.1467-789X.2007.00442.x.

  PMID: 18307703 BACKGROUND

Related Links

• Report of Population Health Survey 2020-22 (Part II) (2023), Non-Communicable Diseases Watch, , Centre for Health Protection, Department of Health, HKSAR
• Consequences of obesity, CDC (Centers for Disease Control and Prevention).

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Central Study Contacts

Lorna Kwai Ping Suen, BN, MPH, PhD

CONTACT

(852) 3725 6228; lornasuen@twc.edu.hk

Chun Kin Mak, Bachelor of Chinese Medicine

CONTACT

(852) 37256194; dickymak@twc.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: April 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)