Auricular Acupressure Integrated With Mobile Device for Weight Reduction

NCT03442712 | Completed

• 1 other identifier: UADZ
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss; Mobile Application; Ear Acupressure

Keywords

obesity; weight loss; ear acupressure; smartphone application

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Appetite parameters which include hunger, fullness and satiety level

  up to 8 weeks

• Leptin concentration

  up to 8 weeks

• Adiponectin level

  up to 8 weeks

• Participants' expectation

  baseline

• Patient satisfaction

  up to 8 weeks

Study Arms (3)

Treatment arm 1

ACTIVE COMPARATOR

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.

Other: Auricular acupressure plus smartphone App

Treatment arm 2

ACTIVE COMPARATOR

The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.

Other: Auricular acupressure

Treatment arm 3

NO INTERVENTION

The participants in the waitlist control group will maintain their usual dietary and exercising patterns.

Interventions

Auricular acupressure plus smartphone App OTHER

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.

Treatment arm 1

Auricular acupressure OTHER

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.

Treatment arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Lorna Suen, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The effects of the treatment will be evaluated by another researcher (second RA) who is blinded to the type of treatment modality received by the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a three-arm randomised waitlist-controlled feasibility trial.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 22, 2018
• Study Start: April 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)