Acupuncture for Body Weight Control
1 other identifier
interventional
72
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 15, 2017
March 1, 2017
1.2 years
July 30, 2015
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in Body Mass Index (BMI) during treatment and follow up
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 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
Study Arms (2)
Acupuncture group
EXPERIMENTALEight 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.
Control group
SHAM COMPARATORFor 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27457720DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhaoxiang Bian, MD., Ph.D
Hong Kong Baptist University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 6, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
March 15, 2017
Record last verified: 2017-03