Electro-acupuncture for Central Obesity

NCT03815253 | Completed DMC

• 1 other identifier: HKBU-HMRF
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in waist circumference

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

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

Secondary Outcomes (6)

• Changes in hip circumference

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

• Adverse events after treatment and follow up

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

• Changes in waist-to-hip circumference ratio

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

• Changes in Body Mass Index

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

• Changes in body fat percentage

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

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Body 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.

Other: acupuncture

sham-acupuncture group

PLACEBO COMPARATOR

As 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.

Other: acupuncture

Interventions

acupuncture OTHER

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.

Acupuncture group; sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Princess Margaret Hospital, Hong Kong: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 38287303 DERIVED

• 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.

  PMID: 34217283 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhaoxiang Bian, MD., Ph.D

  Hong Kong Chinese Medicine Clinical Study Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: single-blinded, randomized, sham-controlled clinical trial

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 24, 2019
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 28, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

HK (1)