Acupuncture for Body Weight Control

Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; 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; 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.
Sham Comparator: Control group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Investigators: Study Director: Zhaoxiang Bian, MD., Ph.D, Hong Kong Baptist University

Publications and helpful links

General Publications

• Zhong LL, Kun W, Lam TF, Zhang SP, Yang JJ, Ziea TC, Ng B, Bian ZX. The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):346. doi: 10.1186/s13063-016-1458-2.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: obesity; acupuncture; Chinese Medicine
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: AcupBWC001