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Acupuncture for Body Weight Control

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring acupuncture, Chinese Medicine, obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Acupuncture group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in body weight during treatment and follow up
    measured by Omron KARADA Scan Body Composition & Scale

    Secondary Outcome Measures

    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
    Change in waist circumference during treatment and follow up
    Change in hip circumference
    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
    Number of patients with adverse events after treatment

    Full Information

    First Posted
    July 30, 2015
    Last Updated
    March 14, 2017
    Sponsor
    Hong Kong Baptist University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02516878
    Brief Title
    Acupuncture for Body Weight Control
    Official Title
    Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hong Kong Baptist University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    acupuncture, Chinese Medicine, obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in body weight during treatment and follow up
    Description
    measured by Omron KARADA Scan Body Composition & Scale
    Time Frame
    The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up
    Secondary Outcome Measure Information:
    Title
    Change in Body Mass Index (BMI) during treatment and follow up
    Description
    The change in Body Mass Index (BMI) will be measured by Omron KARADA Scan Body Composition & Scale
    Time Frame
    The change in BMI will be assessed every two weeks during 8-week treatment and 8-week follow up
    Title
    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
    Title
    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
    Title
    Change in body fat percentage during treatment and follow up
    Description
    The change in body fat percentage will be measured by Omron KARADA Scan Body Composition & Scale
    Time Frame
    The change in body fat percentage will be assessed every two weeks during 8-week treatment and 8-week follow up
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhaoxiang Bian, MD., Ph.D
    Organizational Affiliation
    Hong Kong Baptist University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27457720
    Citation
    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.
    Results Reference
    derived

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    Acupuncture for Body Weight Control

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