ObesityNCT03442712
Auricular Acupressure Integrated With Mobile Device for Weight Reduction
A study testing Auricular acupressure plus smartphone App and Auricular acupressure in people with Obesity and Weight Loss, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Mobile Application
- What is being tested?
- Auricular acupressure plus smartphone App and Auricular acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.
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.
- Conditions
- Obesity, Weight Loss, Mobile Application, Ear Acupressure
- Being tested
- Auricular acupressure plus smartphone App, Auricular acupressure
- Keywords
- obesity, weight loss, ear acupressure, smartphone application
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressure plus smartphone AppOther
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 acupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Auricular acupressure |
| Treatment arm 3 | No intervention | The participants in the waitlist control group will maintain their usual dietary and exercising patterns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
Secondary outcomes (8)
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
Adiponectin level
Adiponectin level will be measured with a commercially available sandwich ELISA kit
Measured: up to 8 weeks
Participants' expectation
A 5-item participants' expectation questionnaire will be collected from the participants.
Measured: baseline
Patient satisfaction
Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.
Measured: up to 8 weeks
Bowel open
bowel open per day
Measured: up to 8 weeks
Fat percentage
this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
Measured: up to 8 weeks
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
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Apr 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three-arm randomised waitlist-controlled feasibility trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorna Suen, The Hong Kong Polytechnic University
- Investigators
- Lorna Suen, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442712
- Sponsor's protocol ID
- UADZ
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.
- ClinicalTrials.gov ID
- NCT03442712
- Acronym / sponsor ID
- UADZ
- Conditions
- Obesity, Weight Loss, Mobile Application, Ear Acupressure
- Keywords
- obesity, weight loss, ear acupressure, smartphone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three-arm randomised waitlist-controlled feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Active comparator | Other: Auricular acupressure plus smartphone AppAuricular 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 arm 2 | Active comparator | Other: Auricular acupressureThe participants will only receive AA treatment and are required to perform daily self-administered seeds pressing. |
| Treatment arm 3 | No intervention | –The participants in the waitlist control group will maintain their usual dietary and exercising patterns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupressure plus smartphone AppSemen 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. | Other | Treatment arm 1 |
| Auricular acupressureThe 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. | Other | Treatment arm 2 |
Primary outcome
body mass index
Time frame: up to 8 weeks
body mass index is defined as the body mass divided by the square of the body height, i.e. kg/meter square
8 secondary outcomes
Appetite parameters which include hunger, fullness and satiety level
Time frame: up to 8 weeks
Leptin concentration
Time frame: up to 8 weeks
Adiponectin level
Time frame: up to 8 weeks
Participants' expectation
Time frame: baseline
Patient satisfaction
Time frame: up to 8 weeks
Bowel open
Time frame: up to 8 weeks
Fat percentage
Time frame: up to 8 weeks
waist hip ratio
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 31144666Suen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Suen, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure plus smartphone App and Auricular acupressure in people with Obesity and Weight Loss, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.