Overview

This trial is active, not recruiting.

Condition obesity
Treatment acupuncture
Sponsor Hong Kong Baptist University
Start date August 2015
End date October 2016
Trial size 72 participants
Trial identifier NCT02516878, AcupBWC001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.
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.

Primary Outcomes

Measure
Change in body weight during treatment and follow up
time frame: The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up

Secondary Outcomes

Measure
Change in Body Mass Index (BMI) during treatment and follow up
time frame: 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
time frame: The change in waist circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
Change in hip circumference
time frame: 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
time frame: 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
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hong Kong Baptist University.