- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442712
Auricular Acupressure Integrated With Mobile Device for Weight Reduction
Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- School of Nursing, the Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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.
|
Active Comparator: Treatment arm 2
The participants will only receive AA treatment and are required to perform daily self-administered seeds pressing.
|
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.
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No Intervention: Treatment arm 3
The participants in the waitlist control group will maintain their usual dietary and exercising patterns.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite parameters which include hunger, fullness and satiety level
Time Frame: up to 8 weeks
|
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.
|
up to 8 weeks
|
Leptin concentration
Time Frame: up to 8 weeks
|
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.
|
up to 8 weeks
|
Adiponectin level
Time Frame: up to 8 weeks
|
Adiponectin level will be measured with a commercially available sandwich ELISA kit
|
up to 8 weeks
|
Participants' expectation
Time Frame: baseline
|
A 5-item participants' expectation questionnaire will be collected from the participants.
|
baseline
|
Patient satisfaction
Time Frame: up to 8 weeks
|
Patient satisfaction towards the therapy, the use of the smartphone app and the implementation of the treatment protocol will be determined.
|
up to 8 weeks
|
Bowel open
Time Frame: up to 8 weeks
|
bowel open per day
|
up to 8 weeks
|
Fat percentage
Time Frame: up to 8 weeks
|
this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
|
up to 8 weeks
|
waist hip ratio
Time Frame: up to 8 weeks
|
It is the dimensionless ratio of the circumference of the waist to that of the hips, calculated as waist measurement divided by hip measurement
|
up to 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lorna Suen, PhD, School of Nursing, the Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UADZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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