Electro-acupuncture for Central Obesity

Not Applicable

Completed

• Conditions: Central Obesity

• Registration Number: NCT03815253
• Lead Sponsor: Hong Kong Baptist University

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.

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.

Study Timeline

• Study First Submitted: 2019-01-12
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-24
• Study Start: 2019-02-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in waist circumference	0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks	Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).

Secondary Outcome Measures

Name	Time	Method
Changes in hip circumference	0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks	hip circumference measured at the level of maximum posterior extension of the buttocks
Adverse events after treatment and follow up	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks	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.
Changes in waist-to-hip circumference ratio	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks	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 ).
Changes in Body Mass Index	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks	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.
Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)	0, 8 weeks	Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.
Changes in body fat percentage	0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks	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.

Trial Locations

Locations (1)

Linda Zhong; 🇭🇰 Kowloon Tong, Kowloon, Hong Kong