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

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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.