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Central ObesityNCT03815253

Electro-acupuncture for Central Obesity

A study testing acupuncture in people with Central Obesity, run by Hong Kong Baptist University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Central Obesity
What is being tested?
acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
1 siteHong Kong
Study dates
1 Feb 2019to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Who cannot join

  • Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Linda Zhong

    Kowloon Tong, Kowloon

Other trials in Hong Kong

About this study

Official title: Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Read the detailed description

This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Conditions
Central Obesity
Being tested
acupuncture
Medical subject headings
Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acupunctureOther

    Body electro-acupuncture will choose eight acupoints 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).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.

    We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.

Study groups in NCT03815253
Study groupRoleWhat they receive
Acupuncture groupExperimentalBody electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks. Body electro-acupuncture will choose eight acupoints 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).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
Receives: Other: acupuncture
sham-acupuncture groupPlacebo comparatorAs to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.
Receives: Other: acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in waist circumference

    Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).

    Measured: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks

Secondary outcomes (6)

  1. Changes in hip circumference

    hip circumference measured at the level of maximum posterior extension of the buttocks

    Measured: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks

  2. Adverse events after treatment and follow up

    Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.

    Measured: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

  3. Changes in waist-to-hip circumference ratio

    waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).

    Measured: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

  4. Changes in Body Mass Index

    Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

    Measured: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

  5. Changes in body fat percentage

    The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.

    Measured: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks

  6. Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)

    Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.

    Measured: 0, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion31 Jan 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
single-blinded, randomized, sham-controlled clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815253
Sponsor's protocol ID
HKBU-HMRF
Status last verified
Mar 2021
First submitted
12 Jan 2019
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lam TF, Lyu Z, Wu X, Wong YP, Cao P, Wong EY, Hung HB, Zhang S, Bian Z, Zhong LLD. Electro-acupuncture for central obesity: a patient-assessor blinded, randomized sham-controlled clinical trial. BMC Complement Med Ther. 2024 Jan 29;24(1):62. doi: 10.1186/s12906-024-04340-5.

    PubMed 38287303

  • Zhong LLD, Wu X, Lam TF, Wong YP, Cao P, Wong EY, Zhang S, Bian Z. Electro-acupuncture for central obesity: randomized, patient-assessor blinded, sham-controlled clinical trial protocol. BMC Complement Med Ther. 2021 Jul 3;21(1):190. doi: 10.1186/s12906-021-03367-2.

    PubMed 34217283

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture in people with Central Obesity, run by Hong Kong Baptist University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in waist circumference (time frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815253, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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