ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000964213

Ethics application status

Approved

Date submitted

18/05/2018

Date registered

7/06/2018

Date last updated

7/07/2020

Date data sharing statement initially provided

4/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The clinical evaluation of electroacupuncture combined with mindfulness meditation in the weight management

Scientific title

The effectiveness and safety of electroacupuncture combined with mindfulness meditation in the management of obesity

Secondary ID [1]

NONE

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight

Obesity

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All randomised participants will have one treatment session per week for a period of 12 weeks and a 8 week follow up period.
Electroacupuncture (EA)
The intervention consists of 12 weekly sessions, each session includes EA treatment with 30 mins needles retention EA point selection includes Zusanli (ST36), Sanyinjiao (SP6), Tianshu (ST25), Zhongwan (CV12), Fenglong (ST40), Guanyuan (CV4), Qihai (CV6), Yinlingquan (SP9). The location of the acupuncture points will follow the standard point location in western Pacific region published by WHO (World Health Organization, 2008).
Stainless steel single-use disposable needles (Seirin, Seirin Coporation, Japan) will be used and the needles are sterilised, individually packed with a length of 40 mm. Skin sterilisation will be performed by applying 70% isopropyl alcohol swab to the area. All acupuncture points will be needled perpendicularly with guide tube. Insertion depth will be approximately 25 mm, depending on the location of individual points. Each point will be connected to an electro-stimulator continuous wave at a frequency of 30 Hz. All needles will be removed after 30 minutes of electro-stimulation.
A registered acupuncturist will be responsible for administering the EA treatments; they will also be responsible for recording each treatment into the participant’s treatment logbook. The details of the logbook include date, time, the duration of the treatment, practice of mindfulness meditation, adverse event and signed by the acupuncturist.
Mindfulness Meditation
The mindfulness meditation (MM) intervention involved practising a 10-minutes pre-recorded mindfulness meditation after each acupuncture treatment. They will also be instructed to self-practise mindfulness meditation daily at their own time, and be given a logbook to record the frequency and duration of their self-practised mindfulness meditation.
This MM is adapted from the MB-EAT program which developed by Jean Kristeller (Kristeller & Hallett, 1999). It is a sitting meditation to be practised in individual settings, which requires participants to focus on their awareness through breathing, and the audio will be recorded by a registered psychologist. A copy of the mindfulness meditation information and instruction booklet will be given to the participants in the first treatment session. The booklet will explain what mindfulness meditation is, and provides clear instruction for practising mindfulness meditation.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Sham Electroacupuncture (SEA)
The SEA also consist of 12 weekly sessions, this is penetrating sham acupuncture on non-acupuncture points (1 cm away from acupuncture point and meridian). The same type of acupuncture needles will be used for SEA with the exact skin sterilisation method. All acupuncture points will be needled perpendicularly with guide tube. Insertion depth will be approximately 25mm, depending on the location of individual points. Each point will be connected to a sham electro-stimulator (showing a continuous wave at frequency of 30 Hz but without actual stimulation). All needles will be removed after 30 minutes of electro-stimulation.

Control group

Active

Outcomes

Primary outcome [1]

Change in BMI, BMI is calculated by Body weight (in Kg) divided by the square of body height in metre. The measurements will be taken at RMIT University Chinese Medicine Research Laboratory, Body height will be measured using a body height measuring tape while a balance scale will be used for measuring the body weight.

Timepoint [1]