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Auricular Acupressure Integrated With Mobile Device for Weight Reduction

Primary Purpose

Obesity, Weight Loss, Mobile Application

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Auricular acupressure plus smartphone App
Auricular acupressure
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, ear acupressure, smartphone application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Treatment arm 1

Treatment arm 2

Treatment arm 3

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Adiponectin level
Adiponectin level will be measured with a commercially available sandwich ELISA kit
Participants' expectation
A 5-item participants' expectation questionnaire will be collected from the participants.
Patient satisfaction
Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.
Bowel open
bowel open per day
Fat percentage
this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
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

Full Information

First Posted
February 12, 2018
Last Updated
February 20, 2019
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03442712
Brief Title
Auricular Acupressure Integrated With Mobile Device for Weight Reduction
Official Title
Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Mobile Application, Ear Acupressure
Keywords
obesity, weight loss, ear acupressure, smartphone application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a three-arm randomised waitlist-controlled feasibility trial.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm 1
Arm Type
Active Comparator
Arm 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.
Arm Title
Treatment arm 2
Arm Type
Active Comparator
Arm Description
The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.
Arm Title
Treatment arm 3
Arm Type
No Intervention
Arm Description
The participants in the waitlist control group will maintain their usual dietary and exercising patterns.
Intervention Type
Other
Intervention Name(s)
Auricular acupressure plus smartphone App
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Auricular acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
body mass index
Description
body mass index is defined as the body mass divided by the square of the body height, i.e. kg/meter square
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Appetite parameters which include hunger, fullness and satiety level
Description
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.
Time Frame
up to 8 weeks
Title
Leptin concentration
Description
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.
Time Frame
up to 8 weeks
Title
Adiponectin level
Description
Adiponectin level will be measured with a commercially available sandwich ELISA kit
Time Frame
up to 8 weeks
Title
Participants' expectation
Description
A 5-item participants' expectation questionnaire will be collected from the participants.
Time Frame
baseline
Title
Patient satisfaction
Description
Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.
Time Frame
up to 8 weeks
Title
Bowel open
Description
bowel open per day
Time Frame
up to 8 weeks
Title
Fat percentage
Description
this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
Time Frame
up to 8 weeks
Title
waist hip ratio
Description
It is the dimensionless ratio of the circumference of the waist to that of the hips, calculated as waist measurement divided by hip measurement
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna Suen, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31144666
Citation
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.
Results Reference
derived

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Auricular Acupressure Integrated With Mobile Device for Weight Reduction

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