Trial Review

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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] 294910 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 307872 0
Obesity 307915 0
Condition category
Condition code
Alternative and Complementary Medicine 306913 306913 0 0
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] 301221 0
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] 305921 0
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] 305921 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.
Primary outcome [2] 305954 0
Change in Body weight will be assessed. Where it will be measured by a balance scale located at RMIT University Chinese Medicine Research Laboratory.
Timepoint [2] 305954 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.
Primary outcome [3] 305958 0
Change in waist and hip ratio. Where the measurements will take place at RMIT University Chinese Medicine Research Laboratory. Waist circumference will be measured at the midpoint between the lower margin of the rib and the superior border of the iliac crest. Hip circumference will be measured from the widest point of the buttocks, and the measuring tape is to be kept parallel to the floor.
Timepoint [3] 305958 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.
Secondary outcome [1] 347037 0
Quality of life related to weight: Weight-related symptom measure (WRSM)
Timepoint [1] 347037 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.
Secondary outcome [2] 347105 0
Quality of life by using obesity and weight loss quality of life (OWL-QOL)
Timepoint [2] 347105 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.
Secondary outcome [3] 347106 0
Psychological influence on food intake by using Power of food Scale
Timepoint [3] 347106 0
3, 6, 9. 12(primary endpoint).14.16,20 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Being overweight (BMI greater or equal to 25)
Adult, with age between 18 and 60.
Be available during the period of this clinical trial
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Serious chronic medical conditions, such as cardiovascular diseases, cancer, HIV, epilepsy
- Pregnancy or lactation.
- Drug induced secondary obesity
- Medical conditions which are known to link with obesity, such as uncontrolled high blood pressure, polycystic ovary syndrome, hypothyroidism, Cushing syndrome, Hashimoto’s Disease
- Mental conditions such as clinical depression, anxiety, PTSD, psychosis
- Participants who are not willing to be treated by acupuncture or to practice meditation.
- Difficulties with understanding and reading English
- Taking blood thinning medications
- Auditory impairment who cannot listen to audio records
- Participants who received treatment for obesity in the past 3 months, including medical treatment or participated in weight loss programs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised into three groups. The code will be placed in individually sealed opaque envelopes, which contains the information about the allocated treatment group. All participants will be selecting their envelope from the available envelopes and hand over to the researcher. The researcher will ensure that the envelope will not be opened until the name of the allocated participants is written on the envelope. Group assignments will not be changed after the allocation has made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will be responsible for generating simple randomisation code by using a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using Statistical Package for Social Science (SPSS) at the Discipline of Chinese Medicine, School of Health and Biomedical Science, RMIT University. Intention to Treat (ITT) analysis will also be performed for participants who are randomised and participated in at least 1 treatment session. Continuous variables will be summarised by using the mean, standard deviation, and 95% confidence intervals (CIs), while quantitative variables will be presented by using the maximum and minimum values. Baseline data and clinical characteristics will be used for comparing the baseline data between intervention groups. Analysis of covariance (ANCOVA) will be performed on BMI and WHR to determine the mean difference between groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2019
Actual
6/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22686 0
3083 - Bundoora
Recruitment postcode(s) [2] 22687 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 299490 0
University
Name [1] 299490 0
RMIT University
Country [1] 299490 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
RMIT, Plenty Road Bundoora, VIC, 3083
Country
Australia
Secondary sponsor category [1] 298811 0
None
Name [1] 298811 0
Address [1] 298811 0
Country [1] 298811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300396 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 300396 0
124 La Trobe Street, Melbourne Victoria 3000
Ethics committee country [1] 300396 0
Australia
Date submitted for ethics approval [1] 300396 0
30/04/2018
Approval date [1] 300396 0
05/09/2018
Ethics approval number [1] 300396 0

Summary
Brief summary
Study design: This is a pilot single-blinded randomised sham-controlled clinical trial with three-armed group design. Participants: Eligible participants must fulfil the inclusion criteria a) Being overweight (BMI greater or equal to 25) or obese with BMI between 30 and less 40; b) Adult with age over 18 years old; c) Be available during the period of this clinical trial; d) Agree to provide written consent for participating this clinical trial. The exclusion criteria: a) Serious chronic medical conditions, such as cardiovascular diseases, cancer, HIV; b) Pregnancy or lactation; c) Drug induced secondary obesity; d) Medical conditions which are known to link with obesity, such as polycystic ovary syndrome, hypothyroidism, Cushing syndrome, Hashimoto’s Disease; e) Mental conditions such as clinical depression and anxiety; f) Participants who are not willing to be treated by acupuncture or to practise meditation; g) Difficulties in understanding and reading English; h) Taking blood thinning medications; i) Auditory disorders who cannot listen to audio records; j) Participants who received treatment for overweight in the past 3 months, including medical treatment or participation in weight loss programs. Sample size was calculated based on the study by Gugel et al. (2012) comparing the acupuncture group with the sham acupuncture on BMI after treatment, the effect size estimate was 0.56. The sample size pilot trial will be 10 participants per group. The recruited participants will be randomised in to 3 groups: Electroacupuncture plus Mindfulness Meditation (EAM), Sham Electroacupuncture plus Mindfulness Meditation (SAM) and Electroacupuncture only (EAO). Treatment protocol: After two-week run-in period, all randomised participants will receive 1 session per week for 12 weeks and 8 weeks follow-up. During each session, the EAM group will receive 30-minute real EA using 8 weight-loss specific points and 10-minute MM practice with instructions for daily practice. SAM group will receive 30 minute SAM with 8 sham acupuncture points (1cm away from real acupuncture points and meridian) and10-minute MM practice. The EAO group will receive only real EA without MM. Data collections: The data will be collected at week 0, 3, 6, 9, 12, 14, 16, 20 weeks using validated and licensed instruments (obtained). Outcome measures include weight, BMI, waist and hips ratio, weight-related symptom measure (WRSM) and obesity and weight loss quality of life (OWL-QOL), Food intake and Power of food scale. The ethics application has been submitted to RMIT-HREC for approval. Statistical analysis: All collected data will be analysed comparing between groups and within group using SPSS. Intention-to-treat analysis will be applied to all clinical data collected.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2730 2730 0 0
/AnzctrAttachments/375116-Protocol.docx (Protocol)
Attachments [2] 2731 2731 0 0
/AnzctrAttachments/375116-V5 human ethics approval form.pdf (Ethics approval)
Attachments [3] 2732 2732 0 0
/AnzctrAttachments/375116-Participant Information Sheet and Consent Form.docx (Participant information/consent)

Contacts
Principal investigator
Name 83522 0
Dr George Lenon
Address 83522 0
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Country 83522 0
Australia
Phone 83522 0
+61,03,99256587
Fax 83522 0
Email 83522 0
[email protected]
Contact person for public queries
Name 83523 0
Ms Ching Yee Chung
Address 83523 0
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Country 83523 0
Australia
Phone 83523 0
+61 0490454044
Fax 83523 0
Email 83523 0
[email protected]
Contact person for scientific queries
Name 83524 0
Dr George Lenon
Address 83524 0
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Country 83524 0
Australia
Phone 83524 0
+61,03,99256587
Fax 83524 0
Email 83524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participant data will not be available due to the compliance of the human research ethics approval that these data involve sensitive information, sharing of these data to the public will invade the privacy of the participants.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe clinical evaluation of electroacupuncture combined with mindfulness meditation for overweight and obesity: study protocol for a randomized sham-controlled clinical trial.2022https://dx.doi.org/10.1186/s13063-022-06725-8
N.B. These documents automatically identified may not have been verified by the study sponsor.