This study will investigate whether the combination of moxibustion and characteristic lifestyle intervention of TCM can alleviate the clinical symptoms and improve quality of life and mental health in patients with abdominal obesity. The results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of TCM in patients with abdominal obesity.
This study will be a randomized controlled trial conducted from January, 2020 to January, 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio.The intervention group will receive moxibustion combined with characteristic lifestyle intervention of TCM;the other group will receive moxibustion combined with lifestyle intervention;the control group will receive lifestyle intervention only.Each treatment will last 12 weeks including 8 weeks of intervention period and 4 weeks of follow-up period. The primary outcome is the waist circumference(WC),the secondary outcomes include obesity-related indicators,serum biochemical indexs,blood pressure, conversion score of constitution characteristics, and measurement of the scale.Adverse events will be recorded during the intervention and follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
1. The moxibustion acupoints will be selected as①zhongwan, guanyuan, shenque, and zusanli;②pishu,shenshu. Acupoints group①will be selected on Monday, Wednesday, and Friday, Acupoints group②will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks. 2. Xiusheng decoction, traditional exercises, and modern lifestyle intervention will be combined as the characteristic lifestyle intervention method of TCM to help participants establish healthy living habits. The Xiusheng Decoction should be taken twice a day. Traditional exercises will be taken for 35\~40 minutes everyday, 7 times a week. The intervention of Xiusheng Decoction and traditional exercises will be conducted for 8 weeks. All patients will be instructed to follow a good living habits which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.
1. The moxibustion acupoints will be selected as①zhongwan, guanyuan, shenque, and zusanli;②pishu,shenshu. Acupoints group①will be selected on Monday, Wednesday, and Friday, Acupoints group②will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks. 2. All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.
All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.
Changes in waistline
Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
Changes in weight
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
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.
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
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 a body composition analyzer (OMRON V.BODY).
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
Changes in basal metabolic value
Basal metabolic value will be measured by a body composition analyzer (OMRON V.BODY).
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
Changes in hip circumference
hip circumference will be measured at the level of maximum posterior extension of the buttocks.
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
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 ).
Time frame: week 0,week 2,week 4,week 6,week 8,week 12
Changes in fasting blood-glucose
examined with the blood sample
Time frame: week 0, week 8
Changes in fasting insulin
examined with the blood sample
Time frame: week 0, week 8
Changes in insulin resistance index insulin resistance index insulin resistance index
examined with the blood sample
Time frame: week 0, week 8
Changes in total cholesterol
examined with the blood sample
Time frame: week 0, week 8
Changes in triglyceride
examined with the blood sample
Time frame: week 0, week 8
Changes in low density lipoprotein
examined with the blood sample
Time frame: week 0, week 8
Changes in high-density lipoprotein
examined with the blood sample
Time frame: week 0, week 8
Changes in uric acid
examined with the blood sample
Time frame: week 0, week 8
Changes in blood pressure
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
Time frame: week 0, week 8
Changes in Conversion score of constitution characteristics
The scale classification of the patient's constitution according to Traditional Chinese Medicine theory into nine constitutions. The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine body constitution types: balanced (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). A higher score in the CCMQ scale indicates a higher likelihood of the specific body constitution. The original score is sum up each item's score. The conversion score of constitution characteristics is \[(original scores- items)/(items\*40\]\*100. The balanced constitution is the converted score \>60 and the rest constitutions' converted scores all \< 30. The unbalanced constitution is the converted score ≥40.
Time frame: week 0, week 8, week 12
Changes in the IWQOL - Lite scale score
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best).
Time frame: week 0, week 8, week 12
Changes in the Emotional and Psychological Assessment scale
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 12
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