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

Not Applicable

• Conditions: Obesity
• Interventions: Device: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine; Device: Moxibustion combined with lifestyle intervention.; Device: lifestyle intervention

• Registration Number: NCT04501198
• Lead Sponsor: Hubei Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-08-01
• Study First Posted: 2020-08-06
• Status Verified: 2020-09
• Study Start: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion with characteristic lifestyle intervention of TCM	moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine	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.
moxibustion with lifestyle intervention	Moxibustion combined 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.
lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Changes in waistline	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).

Secondary Outcome Measures

Name	Time	Method
Changes in weight	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).
Changes in body mass index	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.
Changes in body fat percentage	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).
Changes in basal metabolic value	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).
Changes in hip circumference	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.
Changes in waist-to-hip circumference ratio	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 ).
Changes in fasting blood-glucose	week 0, week 8	examined with the blood sample
Changes in fasting insulin	week 0, week 8	examined with the blood sample
Changes in low density lipoprotein	week 0, week 8	examined with the blood sample
Changes in high-density lipoprotein	week 0, week 8	examined with the blood sample
Changes in insulin resistance index insulin resistance index insulin resistance index	week 0, week 8	examined with the blood sample
Changes in uric acid	week 0, week 8	examined with the blood sample
Changes in total cholesterol	week 0, week 8	examined with the blood sample
Changes in triglyceride	week 0, week 8	examined with the blood sample
Changes in Conversion score of constitution characteristics	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.
Changes in the IWQOL - Lite scale score	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).
Changes in the Emotional and Psychological Assessment scale	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.
Changes in blood pressure	week 0, week 8	Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).