<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501198</url>
  </required_header>
  <id_info>
    <org_study_id>202006009</org_study_id>
    <nct_id>NCT04501198</nct_id>
  </id_info>
  <brief_title>Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial</brief_title>
  <official_title>Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hubei Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanxi Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Bao'an Traditional Chinese Medicine Hospital Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangyang Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hubei Hospital of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate whether the combination of moxibustion and characteristic&#xD;
      lifestyle intervention of TCM can alleviate the clinical symptoms and improve quality of life&#xD;
      and mental health in patients with abdominal obesity. The results are expected to provide&#xD;
      clinical evidence for the application of the combination of moxibustion and characteristic&#xD;
      lifestyle intervention of TCM in patients with abdominal obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized controlled trial conducted from January, 2020 to January,&#xD;
      2022 that includes 150 participants who have abdominal obesity and meet the eligibility&#xD;
      criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation&#xD;
      ratio.The intervention group will receive moxibustion combined with characteristic lifestyle&#xD;
      intervention of TCM;the other group will receive moxibustion combined with lifestyle&#xD;
      intervention;the control group will receive lifestyle intervention only.Each treatment will&#xD;
      last 12 weeks including 8 weeks of intervention period and 4 weeks of follow-up period. The&#xD;
      primary outcome is the waist circumference(WC),the secondary outcomes include obesity-related&#xD;
      indicators,serum biochemical indexs,blood pressure, conversion score of constitution&#xD;
      characteristics, and measurement of the scale.Adverse events will be recorded during the&#xD;
      intervention and follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in waistline</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <description>Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <description>Body weight will be measured by a body composition analyzer (OMRON V.BODY).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body fat percentage</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in basal metabolic value</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <description>Basal metabolic value will be measured by a body composition analyzer (OMRON V.BODY).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hip circumference</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <description>hip circumference will be measured at the level of maximum posterior extension of the buttocks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist-to-hip circumference ratio</measure>
    <time_frame>week 0,week 2,week 4,week 6,week 8,week 12</time_frame>
    <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 ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting blood-glucose</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting insulin</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin resistance index insulin resistance index insulin resistance index</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total cholesterol</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglyceride</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in low density lipoprotein</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in high-density lipoprotein</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in uric acid</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>examined with the blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>week 0, week 8</time_frame>
    <description>Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Conversion score of constitution characteristics</measure>
    <time_frame>week 0, week 8, week 12</time_frame>
    <description>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 &gt;60 and the rest constitutions' converted scores all &lt; 30. The unbalanced constitution is the converted score ≥40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the IWQOL - Lite scale score</measure>
    <time_frame>week 0, week 8, week 12</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Emotional and Psychological Assessment scale</measure>
    <time_frame>week 0, week 8, week 12</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Moxibustion with characteristic lifestyle intervention of TCM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moxibustion with lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lifestyle intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Moxibustion with characteristic lifestyle intervention of TCM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Moxibustion combined with lifestyle intervention.</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>moxibustion with lifestyle intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lifestyle intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>lifestyle intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients recruited for this study should meet the following inclusion criteria:&#xD;
&#xD;
        1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55&#xD;
        years old; 3.Being able to fully understand and voluntarily sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's&#xD;
             syndrome; uncorrected thyroid disease.&#xD;
&#xD;
          2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney&#xD;
             functions, or mental diseases.&#xD;
&#xD;
          3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.&#xD;
&#xD;
          4. History of bulimia, anorexia, or any other eating disorders.&#xD;
&#xD;
          5. Use of medications in the past 3 months, such as diet drugs, corticosteroids,&#xD;
             antidepressants, which may affect weight or appetite.&#xD;
&#xD;
          6. History of surgical weight loss, postoperative adhesions.&#xD;
&#xD;
          7. History of participating in a clinical study of weight loss or any other therapies to&#xD;
             lose weight in the past 3 months.&#xD;
&#xD;
          8. Presence of local skin rupture, allergy and scar constitution.&#xD;
&#xD;
          9. Unable to cooperate with the research caused by other diseases or reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongyu Zhou, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hubei Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhongyu Zhou, Professor</last_name>
    <phone>+86 18672308659</phone>
    <email>2209447940@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Huang, Professor</last_name>
    <phone>+86 13986083982</phone>
    <email>13986083982@qq.com</email>
  </overall_contact_backup>
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    <PMID>28441380</PMID>
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    <citation>Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24.</citation>
    <PMID>27219496</PMID>
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    <citation>Dalle Grave R, Calugi S, El Ghoch M. Lifestyle modification in the management of obesity: achievements and challenges. Eat Weight Disord. 2013 Dec;18(4):339-49. doi: 10.1007/s40519-013-0049-4. Epub 2013 Jul 27.</citation>
    <PMID>23893662</PMID>
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    <citation>Khera R, Murad MH, Chandar AK, Dulai PS, Wang Z, Prokop LJ, Loomba R, Camilleri M, Singh S. Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. JAMA. 2016 Jun 14;315(22):2424-34. doi: 10.1001/jama.2016.7602. Erratum In: JAMA. 2016 Sep 6;316(9):995.</citation>
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    <citation>Reis LO, Favaro WJ, Barreiro GC, de Oliveira LC, Chaim EA, Fregonesi A, Ferreira U. Erectile dysfunction and hormonal imbalance in morbidly obese male is reversed after gastric bypass surgery: a prospective randomized controlled trial. Int J Androl. 2010 Oct 1;33(5):736-44. doi: 10.1111/j.1365-2605.2009.01017.x. Epub 2009 Dec 16.</citation>
    <PMID>20039972</PMID>
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    <citation>Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.</citation>
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    <citation>Yeh TL, Chen HH, Pai TP, Liu SJ, Wu SL, Sun FJ, Hwang LC. The Effect of Auricular Acupoint Stimulation in Overweight and Obese Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2017;2017:3080547. doi: 10.1155/2017/3080547. Epub 2017 Dec 5.</citation>
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    <citation>Tronieri JS, Wadden TA, Walsh OA, Berkowitz RI, Alamuddin N, Gruber K, Leonard S, Chao AM. Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial. Metabolism. 2019 Jul;96:83-91. doi: 10.1016/j.metabol.2019.03.005. Epub 2019 Mar 20.</citation>
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  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hubei Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Wang Jian</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>abdominal obesity</keyword>
  <keyword>moxibustion</keyword>
  <keyword>characteristic lifestyle intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>the data will be published in the form of public papers before January 2022 for public inquiries</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501198
org study id: 202006009
nct id: NCT04501198
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Changes in waistline
time frame: week 0,week 2,week 4,week 6,week 8,week 12
description: Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).
measure: Changes in weight
time frame: week 0,week 2,week 4,week 6,week 8,week 12
description: Body weight will be measured by a body composition analyzer (OMRON V.BODY).
measure: Changes in body mass index
time frame: week 0,week 2,week 4,week 6,week 8,week 12
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.
measure: Changes in body fat percentage
time frame: week 0,week 2,week 4,week 6,week 8,week 12
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).
measure: Changes in basal metabolic value
time frame: week 0,week 2,week 4,week 6,week 8,week 12
description: Basal metabolic value will be measured by a body composition analyzer (OMRON V.BODY).
measure: Changes in hip circumference
time frame: week 0,week 2,week 4,week 6,week 8,week 12
description: hip circumference will be measured at the level of maximum posterior extension of the buttocks.
measure: Changes in waist-to-hip circumference ratio
time frame: week 0,week 2,week 4,week 6,week 8,week 12
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 ).
measure: Changes in fasting blood-glucose
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in fasting insulin
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in insulin resistance index insulin resistance index insulin resistance index
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in total cholesterol
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in triglyceride
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in low density lipoprotein
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in high-density lipoprotein
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in uric acid
time frame: week 0, week 8
description: examined with the blood sample
measure: Changes in blood pressure
time frame: week 0, week 8
description: Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
measure: Changes in Conversion score of constitution characteristics
time frame: week 0, week 8, week 12
description: 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.
measure: Changes in the IWQOL - Lite scale score
time frame: week 0, week 8, week 12
description: 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).
measure: Changes in the Emotional and Psychological Assessment scale
time frame: week 0, week 8, week 12
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.
arm group label: Moxibustion with characteristic lifestyle intervention of TCM
arm group type: Experimental
description: 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.
arm group label: moxibustion with lifestyle intervention
arm group type: Experimental
description: 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.
arm group label: lifestyle intervention
arm group type: Other
description: 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.
intervention type: Device
intervention name: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
description: 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.
arm group label: Moxibustion with characteristic lifestyle intervention of TCM
intervention type: Device
intervention name: Moxibustion combined with lifestyle intervention.
description: 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.
arm group label: moxibustion with lifestyle intervention
intervention type: Device
intervention name: lifestyle intervention
description: 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.
arm group label: lifestyle intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Zhongyu Zhou, Professor
role: Principal Investigator
affiliation: Hubei Hospital of Traditional Chinese Medicine
last name: Zhongyu Zhou, Professor
phone: +86 18672308659
email: 2209447940@qq.com
last name: Wei Huang, Professor
phone: +86 13986083982
email: 13986083982@qq.com
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responsible party type: Principal Investigator
investigator affiliation: Hubei Hospital of Traditional Chinese Medicine
investigator full name: Wang Jian
investigator title: professor
mesh term: Obesity
mesh term: Obesity, Abdominal
sharing ipd: Undecided
ipd description: the data will be published in the form of public papers before January 2022 for public inquiries