Auricular Acupressure Integrated With Mobile Device for Weight Reduction
|ClinicalTrials.gov Identifier: NCT03442712|
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Weight Loss Mobile Application Ear Acupressure||Other: Auricular acupressure plus smartphone App Other: Auricular acupressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a three-arm randomised waitlist-controlled feasibility trial.|
|Masking:||Single (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.|
|Official Title:||Feasibility of Self-administered Auricular Acupressure Integrated With Mobile Device Reminders for Weight Reduction.|
|Actual Study Start Date :||April 1, 2018|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
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
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.
Other: Auricular 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.
No Intervention: Treatment arm 3
The participants in the waitlist control group will maintain their usual dietary and exercising patterns.
- 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
- 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.
- 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.
- Adiponectin level [ Time Frame: up to 8 weeks ]Adiponectin level will be measured with a commercially available sandwich ELISA kit
- Participants' expectation [ Time Frame: baseline ]A 5-item participants' expectation questionnaire will be collected from the participants.
- 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.
- Bowel open [ Time Frame: up to 8 weeks ]bowel open per day
- Fat percentage [ Time Frame: up to 8 weeks ]this include body fat percentage, visceral fat level, and segmental subcutaneous fat percentage
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442712
|School of Nursing, The Hong Kong Polytechnic University|
|Hong Kong, Hong Kong|
|Principal Investigator:||Lorna Suen, PhD||School of Nursing, The Hong Kong Polytechnic University|