Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Device: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
* Device: Moxibustion combined with lifestyle intervention.
* Device: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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. Presence of local skin rupture, allergy and scar constitution. Unable to cooperate with the research caused by other diseases or reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion with characteristic lifestyle intervention of TCM<br>Participants will receive moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine.In this study, 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. Participants will receive the treatment of moxibustion 6 times a week to fulfill a 8-session treatment course, and the intervention of Xiusheng Decoction and Traditional exercises will last for 8 weeks.While the intervention of modern lifestyle intervention will be conducted for 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks. | Device: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine<br>* 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. 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.<br>|
| Experimental: moxibustion with lifestyle intervention<br>Participants will receive moxibustion combined with lifestyle intervention. Participants will receive the treatment of moxibustion 6 times a week to fulfill a 8-session treatment course,while the intervention of modern lifestyle intervention will be conducted for 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks. | Device: Moxibustion combined with lifestyle intervention.<br>* 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. 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.<br>|
| Other: lifestyle intervention<br>Participants will receive lifestyle intervention which includes modern dietary exercise modifications. Participants will receive this treatment for a 8-session treatment course and 4-session follow-up course. | Device: lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waistline | Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button). | week 0,week 2,week 4,week 6,week 8,week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight | Body weight will be measured by a body composition analyzer (OMRON V.BODY). | 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. | 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). | 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). | 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. | 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 ). | week 0,week 2,week 4,week 6,week 8,week 12 | 
| Changes in fasting blood-glucose | examined with the blood sample | week 0, week 8 | 
| Changes in fasting insulin | examined with the blood sample | week 0, week 8 | 
| Changes in insulin resistance index insulin resistance index insulin resistance index | examined with the blood sample | week 0, week 8 | 
| Changes in total cholesterol | examined with the blood sample | week 0, week 8 | 
| Changes in triglyceride | examined with the blood sample | week 0, week 8 | 
| Changes in low density lipoprotein | examined with the blood sample | week 0, week 8 | 
| Changes in high-density lipoprotein | examined with the blood sample | week 0, week 8 | 
| Changes in uric acid | examined with the blood sample | week 0, week 8 | 
| Changes in blood pressure | Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg). | 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. | 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). | 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. | week 0, week 8, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal obesity, moxibustion, characteristic lifestyle intervention