Acupuncture for Body Weight Control

Obesity Clinical Trial

Official title:

Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516878
• Other study ID #: AcupBWC001
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: March 14, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in hip circumference		The change in hip circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
Secondary	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
Secondary	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