Acupuncture for Body Weight Control

Study Overview
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Brief Summary
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In this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in Hong Kong.

Detailed Description
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This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.

Official Title
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Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 65 years old; body mass index (BMI)≥25 kg/m2; having not received any other weight control measures or any medical and/or drug history within the last 3 months. Exclusion Criteria: endocrine diseases; heart diseases; patients with pacemaker; allergy and immunology diseases; having bleeding tendency; pregnant or lactating women; having impaired hepatic or renal function; stroke or otherwise unable to exercise.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes. Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated. | Procedure: Acupuncture<br>* Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes. Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.<br>|
| Sham Comparator: Control group<br>For subjects assigned to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2 / 0.30 x 30 mm) will be applied to serve as sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of insertion. The Semen Vaccariae embedded tape used in treatment group will be applied on 4 non-acupoints at the helix unilaterally, retained until the next visit and then the alternate ear will be used. | Procedure: Acupuncture<br>* Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes. Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight during treatment and follow up | measured by Omron KARADA Scan Body Composition & Scale | The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (BMI) during treatment and follow up | The change in Body Mass Index (BMI) will be measured by Omron KARADA Scan Body Composition & Scale | The change in BMI will be assessed every two weeks during 8-week treatment and 8-week follow up | 
| Change in waist circumference during treatment and follow up |  | The change in waist circumference will be assessed every two weeks during 8-week treatment and 8-week follow up | 
| Change in hip circumference |  | The change in hip circumference will be assessed every two weeks during 8-week treatment and 8-week follow up | 
| Change in body fat percentage during treatment and follow up | The change in body fat percentage will be measured by Omron KARADA Scan Body Composition & Scale | The change in body fat percentage will be assessed every two weeks during 8-week treatment and 8-week follow up | 
| Number of patients with adverse events after treatment |  | Number of patients with adverse events after treatment will be recorded and compared among the two groups during 8-week treatment and 8-week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, Chinese Medicine, obesity