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

Obesity Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04501198
• Other study ID #: 202006009
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: January 2022

Study information

• Verified date: September 2020
• Source: Hubei Hospital of Traditional Chinese Medicine
• Contact: Zhongyu Zhou, Professor
• Phone: +86 18672308659
• Email: 2209447940[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal

Intervention

Device:
• moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
The moxibustion acupoints will be selected as?zhongwan, guanyuan, shenque, and zusanli;?pishu,shenshu. Acupoints group?will be selected on Monday, Wednesday, and Friday, Acupoints group?will 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.
• Moxibustion combined with lifestyle intervention.
The moxibustion acupoints will be selected as?zhongwan, guanyuan, shenque, and zusanli;?pishu,shenshu. Acupoints group?will be selected on Monday, Wednesday, and Friday, Acupoints group?will 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Hubei Hospital of Traditional Chinese Medicine	Shanxi Provincial Hospital of Traditional Chinese Medicine, Shenzhen Bao'an Traditional Chinese Medicine Hospital Group, Wuhan Hospital of Traditional Chinese and Western Medicine, Xiangyang Hospital of Traditional Chinese Medicine

References & Publications (12)

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Freisling H, Arnold M, Soerjomataram I, O'Doherty MG, Ordóñez-Mena JM, Bamia C, Kampman E, Leitzmann M, Romieu I, Kee F, Tsilidis K, Tjønneland A, Trichopoulou A, Boffetta P, Benetou V, Bueno-de-Mesquita HBA, Huerta JM, Brenner H, Wilsgaard T, Jenab M. Comparison of general obesity and measures of body fat distribution in older adults in relation to cancer risk: meta-analysis of individual participant data of seven prospective cohorts in Europe. Br J Cancer. 2017 May 23;116(11):1486-1497. doi: 10.1038/bjc.2017.106. Epub 2017 Apr 25. — View 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. — View 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. Review. — View Citation

Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ, Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang LM, Bessler M, Sarr MG, Swain JM, Laqua P, Jensen MD, Bantle JP. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA. 2013 Jun 5;309(21):2240-9. doi: 10.1001/jama.2013.5835. — View 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. Review. Erratum in: JAMA. 2016 Sep 6;316(9):995. — View Citation

Park BY, Lee MJ, Kim M, Kim SH, Park H. Structural and Functional Brain Connectivity Changes Between People With Abdominal and Non-abdominal Obesity and Their Association With Behaviors of Eating Disorders. Front Neurosci. 2018 Oct 11;12:741. doi: 10.3389/fnins.2018.00741. eCollection 2018. — View 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. — View Citation

Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869. — View 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. — View 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. Review. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in waistline	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	Changes in weight	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
Secondary	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.	week 0,week 2,week 4,week 6,week 8,week 12
Secondary	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).	week 0,week 2,week 4,week 6,week 8,week 12
Secondary	Changes in basal metabolic value	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
Secondary	Changes in hip circumference	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
Secondary	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 ).	week 0,week 2,week 4,week 6,week 8,week 12
Secondary	Changes in fasting blood-glucose	examined with the blood sample	week 0, week 8
Secondary	Changes in fasting insulin	examined with the blood sample	week 0, week 8
Secondary	Changes in insulin resistance index insulin resistance index insulin resistance index	examined with the blood sample	week 0, week 8
Secondary	Changes in total cholesterol	examined with the blood sample	week 0, week 8
Secondary	Changes in triglyceride	examined with the blood sample	week 0, week 8
Secondary	Changes in low density lipoprotein	examined with the blood sample	week 0, week 8
Secondary	Changes in high-density lipoprotein	examined with the blood sample	week 0, week 8
Secondary	Changes in uric acid	examined with the blood sample	week 0, week 8
Secondary	Changes in blood pressure	Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).	week 0, week 8
Secondary	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.	week 0, week 8, week 12
Secondary	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).	week 0, week 8, week 12
Secondary	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.	week 0, week 8, week 12

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