Back to resultsEfficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
Primary Purpose
Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electro-acupuncture
Sham electro-acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Abdominal focused on measuring Abdominal obesity, Electro-acupuncture, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
Patients recruited for this study should meet the following inclusion criteria:
1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.
Exclusion Criteria:
Patients with any of the following criteria will be excluded from the study:
- Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
- Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
- Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
- History of bulimia, anorexia, or any other eating disorders.
- Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
- History of surgical weight loss, postoperative adhesions.
- History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
- Unable to cooperate with the research caused by other diseases or reasons.
Sites / Locations
- Hubei Provincial Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Electro-acupuncture
Sham electro-acupuncture
Arm Description
Participants will receive electro-acupuncture combined with lifestyle intervention. Participants will receive the treatment of electroacupuncture 3 times a week to fulfill a 8-session treatment course.
Participants will receive the treatment of sham electro-acupuncture 3 times a week to fulfill a 8-session treatment course, A superficial skin penetration (2-3 mm in depth) at nonacupoints will be performed in the sham acupuncture group, without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument is interrupted.
Outcomes
Primary Outcome Measures
Change from baseline waistline at 8 weeks.
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
Secondary Outcome Measures
Change from baseline body weight at 8 weeks.
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Change from baseline body mass index at 8 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.
Change from baseline the body fat percentage at 8 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 a body composition analyzer (OMRON V.BODY).
Change from baseline hip circumference at 8 weeks.
Hip circumference will be measured at the level of maximum posterior extension of the buttocks.
Change from baseline waist-to-hip ratio at 8 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 from baseline insulin resistance index at 8 weeks.
Examined with the blood sample.
Changes from baseline blood fat at 8 weeks.
Examined with the blood sample.
Changes from baseline blood pressure at 8 weeks
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
Changes from baseline the IWQOL - Lite scale score at 8 weeks
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) questionnaire, which has a score range from 0(worst) to 100(best).
Changes from baseline the Kessler 10 scale at 8weeks.
10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.
Full Information
NCT ID
NCT04957134
First Posted
June 24, 2021
Last Updated
June 9, 2023
Sponsor
Hubei Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04957134
Brief Title
Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
Official Title
The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.
Detailed Description
The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
Keywords
Abdominal obesity, Electro-acupuncture, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electro-acupuncture
Arm Type
Experimental
Arm Description
Participants will receive electro-acupuncture combined with lifestyle intervention. Participants will receive the treatment of electroacupuncture 3 times a week to fulfill a 8-session treatment course.
Arm Title
Sham electro-acupuncture
Arm Type
Placebo Comparator
Arm Description
Participants will receive the treatment of sham electro-acupuncture 3 times a week to fulfill a 8-session treatment course, A superficial skin penetration (2-3 mm in depth) at nonacupoints will be performed in the sham acupuncture group, without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument is interrupted.
Intervention Type
Device
Intervention Name(s)
Electro-acupuncture
Intervention Description
The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Sham electro-acupuncture
Intervention Description
The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
Primary Outcome Measure Information:
Title
Change from baseline waistline at 8 weeks.
Description
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
Time Frame
week 0,week 4,week 8,week 20,week 32
Secondary Outcome Measure Information:
Title
Change from baseline body weight at 8 weeks.
Description
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Time Frame
week 0,week 4,week 8,week 20,week 32
Title
Change from baseline body mass index at 8 weeks.
Description
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.
Time Frame
week 0,week 4,week 8,week 20,week 32
Title
Change from baseline the body fat percentage at 8 weeks.
Description
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 a body composition analyzer (OMRON V.BODY).
Time Frame
week 0,week 8,week 32
Title
Change from baseline hip circumference at 8 weeks.
Description
Hip circumference will be measured at the level of maximum posterior extension of the buttocks.
Time Frame
week 0,week 4,week 8,week 20,week 32
Title
Change from baseline waist-to-hip ratio at 8 weeks.
Description
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 ).
Time Frame
week 0,week 4,week 8,week 20,week 32
Title
Changes from baseline insulin resistance index at 8 weeks.
Description
Examined with the blood sample.
Time Frame
week 0, week 8
Title
Changes from baseline blood fat at 8 weeks.
Description
Examined with the blood sample.
Time Frame
week 0, week 8
Title
Changes from baseline blood pressure at 8 weeks
Description
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
Time Frame
week 0,week 4,week 8,week 32
Title
Changes from baseline the IWQOL - Lite scale score at 8 weeks
Description
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) questionnaire, which has a score range from 0(worst) to 100(best).
Time Frame
week 0,week 8,week 32
Title
Changes from baseline the Kessler 10 scale at 8weeks.
Description
10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.
Time Frame
week 0,week 8,week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients recruited for this study should meet the following inclusion criteria:
1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.
Exclusion Criteria:
Patients with any of the following criteria will be excluded from the study:
Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
History of bulimia, anorexia, or any other eating disorders.
Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
History of surgical weight loss, postoperative adhesions.
History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
Unable to cooperate with the research caused by other diseases or reasons.
Received acupuncture within 6 months before enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongyu Zhou, Professor
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Provincial Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The overall data outcome will be published in the form of public paper before december 2024.
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Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
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