Auricular Acupressure Integrated With Mobile Device for Weight Reduction

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Weight Loss
Mobile Application
Obesity
Ear Acupressure

Treatments

Other: Auricular acupressure plus smartphone App
Other: Auricular acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT03442712
UADZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 3 patient groups

Treatment arm 1
Active Comparator group
Description:
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:
Other: Auricular acupressure plus smartphone App
Treatment arm 2
Active Comparator group
Description:
The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.
Treatment:
Other: Auricular acupressure
Treatment arm 3
No Intervention group
Description:
The participants in the waitlist control group will maintain their usual dietary and exercising patterns.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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