Back to resultsMoxibustion 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
About this trial
This is an interventional prevention trial for Obesity focused on measuring abdominal obesity, moxibustion, characteristic lifestyle intervention
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.
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
NCT ID
NCT04501198
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
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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