Auricular Acupressure Integrated With Mobile Device for Weight Reduction

Not Applicable

Completed

• Conditions: Mobile Application; Obesity; Weight Loss; Ear Acupressure
• Interventions: Other: Auricular acupressure plus smartphone App; Other: Auricular acupressure

• Registration Number: NCT03442712
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

Obesity is a common global health problem. A three-arm randomised waitlist-controlled feasibility trial is proposed. A total of 59 subjects (19-21 subjects per arm) will be recruited. The three groups are AA plus smartphone application (experimental group); AA only (comparison group); and Waitlist control group. In the experimental group, seeds will be applied on six specific ear acupoints of the subjects by the researcher. Subjects will be requested to apply pressure on the acupoints thrice per day. They will install a smartphone App which will send out regular reminders for pressing, allow the subjects to input the number of bowel open, compliance rate, and difficulties entered during the process for timely advice. The total treatment period will be 8 weeks. Outcome measures will be conducted at baseline and postintervention at 8 weeks, including obesity and anthropometric index, leptin concentration and adiponectin level. Patient satisfaction towards the therapy, the use of the smartphone application and the implementation of the treatment protocol will be determined.

Detailed Description

Obesity is a common global health problem. It increases the risk of many chronic illnesses, such as hypertension, type 2 diabetes mellitus and cardiovascular diseases. Conventional approaches to alleviate obesity are medications, exercise, dietary control, behaviour modification therapy or bariatric surgeries. However, the safety of anti-obesity agents is a concern, and gastric bypass surgery and other bariatric surgeries also pose potential risks after operation. Auricular acupuncture therapy is frequently used to treat obesity. However, the use of needles for auricular acupuncture may be unacceptable to people. Some researchers attempted to adopt a combined approach by integrating auriculotherapy with diet restriction, and the effect solely attributed to auriculotherapy cannot be determined. On the other hand, auricular acupressure (AA) is a safe, noninvasive, inexpensive and easily self-administered approach that causes very few adverse effects. Previous evidence has demonstrated that AA is an effective intervention to reduce body weight, increase satiety and self-efficacy on weight control through the self-administration of seeds pressing several times per day, after the seeds are applied by the researchers on the ear acupoints. It is associated with the decreased leptin levels and an increase of adiponectin level in which these hormones are associated with weight loss. However, therapists may have difficulties to monitor the compliance of subjects to perform seed pressing which in turn affecting the intervention dosages. This study aims to evaluate the feasibility of self-administered AA integrated with mobile device reminders for weight reduction in individuals with overweightness or obesity. A three-arm randomised waitlist-controlled feasibility trial is proposed. A total of 59 subjects (19-21 subjects per arm) will be recruited. The three groups are AA plus smartphone application (experimental group); AA only (comparison group); and Waitlist control group. In the experimental group, seeds will be applied on six specific ear acupoints of the subjects by the researcher. Subjects will be requested to apply pressure on the acupoints thrice per day. They will install a smartphone App which will send out regular reminders for pressing, allow the subjects to input the number of bowel open, compliance rate, and difficulties entered during the process for timely advice. The total treatment period will be 8 weeks. Outcome measures will be conducted at baseline and postintervention at 8 weeks, including obesity and anthropometric index, leptin concentration and adiponectin level. Patient satisfaction towards the therapy, the use of the smartphone application and the implementation of the treatment protocol will be determined.

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2018-04-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Overweightness, with body mass index (BMI) ≥ 25.0 kg/m2 in accordance with the BMI classification of the World Health Organization (WHO)
• Subjects that have neither received other weight control measures (manoeuvres) nor experienced medical and/or drug history within the last 3 months
• No ear injury, such as inflammation or lesions, and no medical history of ear surgery within the last 6 months
• Smartphone user (IOS and android)

Exclusion criteria:

(1) diabetes, severe hypertension, heart disease or endocrine abnormalities,; (2) pregnancy; (3) eating disorders screened with a 5-item SCOFF questionnaire (Bradford et al. 2010); (4) psychiatric and mental disorders.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm 1	Auricular acupressure plus smartphone App	Auricular acupressure (AA) plus smartphone App: Semen Vaccaria laccaria will be applied on one ear only, and seed plasters will be changed every 3 days to 4 days to the opposite ear. Subjects will be requested to apply pressure on the acupoints thrice per day. The subjects will install the smartphone App specifically designed for this study. The App will send out regular AA reminders to the subjects. The total treatment period will be 8 weeks.
Treatment arm 2	Auricular acupressure	The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.

Primary Outcome Measures

Name	Time	Method
body mass index	up to 8 weeks	body mass index is defined as the body mass divided by the square of the body height, i.e. kg/meter square

Secondary Outcome Measures

Name	Time	Method
Bowel open	up to 8 weeks	bowel open per day
Appetite parameters which include hunger, fullness and satiety level	up to 8 weeks	Participants will be asked to compete the Visual Analogue Scale (VAS) before lunch and dinner meals taking an average for three consecutive days at each timepoints (baseline, and post-intervention at 8 weeks), using VAS scale to measure the appetite in terms of hunger, fullness and satiety level.
Adiponectin level	up to 8 weeks	Adiponectin level will be measured with a commercially available sandwich ELISA kit
Fat percentage	up to 8 weeks	this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
Leptin concentration	up to 8 weeks	leptin concentration will be measured in duplicate by using a commercial sandwich ELISA kit comprising ready-to-use components, which are either concentrated or lyophilised.
Participants' expectation	baseline	A 5-item participants' expectation questionnaire will be collected from the participants.
Patient satisfaction	up to 8 weeks	Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.
waist hip ratio	up to 8 weeks	It is the dimensionless ratio of the circumference of the waist to that of the hips, calculated as waist measurement divided by hip measurement

Trial Locations

Locations (1)

School of Nursing, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong