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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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
Moxibustion combined with lifestyle intervention.
lifestyle intervention
Sponsored by
Hubei Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring abdominal obesity, moxibustion, characteristic lifestyle intervention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
  2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
  3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
  4. History of bulimia, anorexia, or any other eating disorders.
  5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
  6. History of surgical weight loss, postoperative adhesions.
  7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
  8. Presence of local skin rupture, allergy and scar constitution.
  9. Unable to cooperate with the research caused by other diseases or reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Moxibustion with characteristic lifestyle intervention of TCM

    moxibustion with lifestyle intervention

    lifestyle intervention

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in waistline
    Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).

    Secondary Outcome Measures

    Changes in weight
    Body weight will be measured by a body composition analyzer (OMRON V.BODY).
    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.
    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).
    Changes in basal metabolic value
    Basal metabolic value will be measured by a body composition analyzer (OMRON V.BODY).
    Changes in hip circumference
    hip circumference will be measured at the level of maximum posterior extension of the buttocks.
    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 ).
    Changes in fasting blood-glucose
    examined with the blood sample
    Changes in fasting insulin
    examined with the blood sample
    Changes in insulin resistance index insulin resistance index insulin resistance index
    examined with the blood sample
    Changes in total cholesterol
    examined with the blood sample
    Changes in triglyceride
    examined with the blood sample
    Changes in low density lipoprotein
    examined with the blood sample
    Changes in high-density lipoprotein
    examined with the blood sample
    Changes in uric acid
    examined with the blood sample
    Changes in blood pressure
    Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
    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.
    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).
    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.

    Full Information

    First Posted
    July 23, 2020
    Last Updated
    September 14, 2020
    Sponsor
    Hubei Hospital of Traditional Chinese Medicine
    Collaborators
    Shanxi Provincial Hospital of Traditional Chinese Medicine, Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Wuhan Hospital of Traditional Chinese Medicine, Xiangyang Hospital of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04501198
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hubei Hospital of Traditional Chinese Medicine
    Collaborators
    Shanxi Provincial Hospital of Traditional Chinese Medicine, Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Wuhan Hospital of Traditional Chinese Medicine, Xiangyang 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
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    abdominal obesity, moxibustion, characteristic lifestyle intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Moxibustion with characteristic lifestyle intervention of TCM
    Arm Type
    Experimental
    Arm 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 Title
    moxibustion with lifestyle intervention
    Arm Type
    Experimental
    Arm 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 Title
    lifestyle intervention
    Arm Type
    Other
    Arm 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(s)
    moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
    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. 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.
    Intervention Type
    Device
    Intervention Name(s)
    Moxibustion combined with lifestyle intervention.
    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.
    Intervention Type
    Device
    Intervention Name(s)
    lifestyle intervention
    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.
    Primary Outcome Measure Information:
    Title
    Changes in waistline
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Changes in weight
    Description
    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
    Title
    Changes in body mass index
    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 2,week 4,week 6,week 8,week 12
    Title
    Changes in body fat percentage
    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 2,week 4,week 6,week 8,week 12
    Title
    Changes in basal metabolic value
    Description
    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
    Title
    Changes in hip circumference
    Description
    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
    Title
    Changes in waist-to-hip circumference ratio
    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 2,week 4,week 6,week 8,week 12
    Title
    Changes in fasting blood-glucose
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in fasting insulin
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in insulin resistance index insulin resistance index insulin resistance index
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in total cholesterol
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in triglyceride
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in low density lipoprotein
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in high-density lipoprotein
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in uric acid
    Description
    examined with the blood sample
    Time Frame
    week 0, week 8
    Title
    Changes in blood pressure
    Description
    Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
    Time Frame
    week 0, week 8
    Title
    Changes in Conversion score of constitution characteristics
    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.
    Time Frame
    week 0, week 8, week 12
    Title
    Changes in the IWQOL - Lite scale score
    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).
    Time Frame
    week 0, week 8, week 12
    Title
    Changes in the Emotional and Psychological Assessment scale
    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 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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. Presence of local skin rupture, allergy and scar constitution. Unable to cooperate with the research caused by other diseases or reasons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhongyu Zhou, Professor
    Phone
    +86 18672308659
    Email
    2209447940@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Huang, Professor
    Phone
    +86 13986083982
    Email
    13986083982@qq.com
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    the data will be published in the form of public papers before January 2022 for public inquiries
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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

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