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

September 14, 2020 updated by: Wang Jian, Hubei Hospital of Traditional Chinese Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhongyu Zhou, Professor
  • Phone Number: +86 18672308659
  • Email: 2209447940@qq.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Moxibustion with characteristic lifestyle intervention of TCM
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
  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.
EXPERIMENTAL: moxibustion with lifestyle intervention
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.
  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.
OTHER: lifestyle intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in waistline
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0,week 2,week 4,week 6,week 8,week 12
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
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in fasting insulin
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in insulin resistance index insulin resistance index insulin resistance index
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in total cholesterol
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in triglyceride
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in low density lipoprotein
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in high-density lipoprotein
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in uric acid
Time Frame: week 0, week 8
examined with the blood sample
week 0, week 8
Changes in blood pressure
Time Frame: week 0, week 8
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
Time Frame: week 0, week 8, week 12
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
Time Frame: week 0, week 8, week 12
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
Time Frame: week 0, week 8, week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Hospital of Traditional Chinese Medicine

Collaborators

Shanxi Provincial Hospital of Traditional Chinese Medicine
Wuhan Hospital of Traditional Chinese Medicine
Shenzhen Bao'an Traditional Chinese Medicine Hospital Group
Xiangyang Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202006009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the data will be published in the form of public papers before January 2022 for public inquiries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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