ClinicalTrials.gg
CompletedNCT03442712Updated Feb 22, 2019

Auricular Acupressure Integrated With Mobile Device for Weight Reduction

An interventional study of Auricular acupressure plus smartphone App and Auricular acupressure in Obesity, Weight Loss and Mobile Application, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Obesity with a site in Hong Kong — 19 open to participants now, 24 under way, 4 of them phase 3. Obesity · Hong Kong.

Enrollment
35th of 46
59 · median 234
Started
2018
with 3 others
No phase
32 of 48
14 open now
Registered
11th of 48
by date
Lead sponsor
5 of 48
The Hong Kong Polytechnic University

Among the 48 studies in Obesity with a site in Hong Kong, this one is the 35th largest by enrollment of the 46 interventional ones that give a count, is one of 4 that started in 2018, is one of 32 with no phase, and was the 11th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

19 of the 48 studies in Obesity with a site in Hong Kong are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in Hong Kong have not opened yet or have stopped. Only those recruiting at a site in Hong Kong →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Obesity
  • Weight Loss
  • Mobile Application
  • Ear Acupressure

Keywords

  • obesity
  • weight loss
  • ear acupressure
  • smartphone application
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Overweightness, with (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

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    Treatment arm 1

    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

  • Active comparator
    Treatment arm 2

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

    Other: Auricular acupressure

  • No intervention
    Treatment arm 3

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

Interventions

  • OtherAuricular 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.

  • OtherAuricular 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.

06

What researchers measure

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

    Time frame: up to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 8 weeks

  2. 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.

    Time frame: up to 8 weeks

  3. Adiponectin level

    Adiponectin level will be measured with a commercially available sandwich ELISA kit

    Time frame: up to 8 weeks

  4. Participants' expectation

    A 5-item participants' expectation questionnaire will be collected from the participants.

    Time frame: baseline

  5. Patient satisfaction

    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

  6. Bowel open

    bowel open per day

    Time frame: up to 8 weeks

  7. Fat percentage

    this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage

    Time frame: up to 8 weeks

  8. 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

    Time frame: up to 8 weeks

07

Study locations

1 site
  • School of Nursing, The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

Publications

  • 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. PubMed 31144666 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Nov 2018, 7 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 7 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2018
First posted
Feb 22, 2018
StartActual
Apr 1, 2018
Primary completionActual
Nov 30, 2018
CompletionActual
Nov 30, 2018
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03442712
Responsible party
Lorna Suen (Associate Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Feb 22, 2018
Start date
Apr 1, 2018
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Feb 22, 2019

Study contacts

Lorna Suen, PhD
principal investigator · School of Nursing, The Hong Kong Polytechnic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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