Auricular Acupressure Integrated With Mobile Device for Weight Reduction

Obesity Clinical Trial

Official title:

Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442712
• Other study ID #: UADZ
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Ear Acupressure
• Mobile Application
• Obesity
• Weight Loss

Intervention

Other:
• Auricular acupressure plus smartphone App
Semen Vaccaria laccaria will be kept in place by a piece of adhesive patch. Seeds will be applied on one ear only, and seed plasters will be changed every 3 days to 4 days to the opposite ear, that is, we will meet the subjects twice per week. Subjects will be requested to apply pressure on the acupoints thrice per day, preferably within 30 min before eating, pressing for 20 times using a constant rhythm to each point. Coaching on how to self-administer AA on the acupoints will be given to the subjects, and a return demonstration from the subjects will be required to ensure the skills are performed properly. The subjects will install the smartphone App specifically designed for this study. The App will send out regular AA reminders to the subjects. In addition, the subjects will be asked to input the number of bowel open and compliance with AA performance per day into the App. The total treatment period will be 8 weeks.
• Auricular acupressure
The participants will receive AA treatment and are required to perform daily self-administered seeds pressing, but no smartphone App will be provided, but a booklet containing relevant information will be provided to the subjects.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index	body mass index is defined as the body mass divided by the square of the body height, i.e. kg/meter square	up to 8 weeks
Secondary	Appetite parameters which include hunger, fullness and satiety level	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.	up to 8 weeks
Secondary	Leptin concentration	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.	up to 8 weeks
Secondary	Adiponectin level	Adiponectin level will be measured with a commercially available sandwich ELISA kit	up to 8 weeks
Secondary	Participants' expectation	A 5-item participants' expectation questionnaire will be collected from the participants.	baseline
Secondary	Patient satisfaction	Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.	up to 8 weeks
Secondary	Bowel open	bowel open per day	up to 8 weeks
Secondary	Fat percentage	this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage	up to 8 weeks
Secondary	waist hip ratio	It is the dimensionless ratio of the circumference of the waist to that of the hips, calculated as waist measurement divided by hip measurement	up to 8 weeks