Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial
- Conditions
- Obesity, Abdominal
- Interventions
- Device: Sham electro-acupunctureDevice: Electro-acupuncture
- Registration Number
- NCT04957134
- Lead Sponsor
- Hubei Hospital of Traditional Chinese Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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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.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham electro-acupuncture Sham electro-acupuncture 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. Electro-acupuncture Electro-acupuncture 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.
- Primary Outcome Measures
Name Time Method Change from baseline waistline at 8 weeks. week 0,week 4,week 8,week 20,week 32 Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
- Secondary Outcome Measures
Name Time Method Change from baseline body weight at 8 weeks. week 0,week 4,week 8,week 20,week 32 Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Change from baseline body mass index at 8 weeks. week 0,week 4,week 8,week 20,week 32 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 hip circumference at 8 weeks. week 0,week 4,week 8,week 20,week 32 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. week 0,week 4,week 8,week 20,week 32 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. week 0, week 8 Examined with the blood sample.
Changes from baseline blood fat at 8 weeks. week 0, week 8 Examined with the blood sample.
Changes from baseline the Kessler 10 scale at 8weeks. week 0,week 8,week 32 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.
Changes from baseline blood pressure at 8 weeks week 0,week 4,week 8,week 32 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 week 0,week 8,week 32 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).
Change from baseline the body fat percentage at 8 weeks. week 0,week 8,week 32 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).
Trial Locations
- Locations (1)
Hubei Provincial Hospital of Traditional Chinese Medicine
🇨🇳Wuhan, Hubei, China