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ObesityNCT04501198

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

A study testing moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine, Moxibustion combined with lifestyle intervention. and lifestyle intervention in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity
What is being tested?
moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine, Moxibustion combined with lifestyle intervention. and lifestyle intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Sep 2020to Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Zhongyu Zhou, Professor contact

+86 18672308659

2209447940@qq.com

Wei Huang, Professor contact

+86 13986083982

13986083982@qq.com

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine, Moxibustion combined with lifestyle intervention., lifestyle intervention
Keywords
abdominal obesity, moxibustion, characteristic lifestyle intervention
Medical subject headings
Obesity, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moxibustion combined with characteristic lifestyle intervention of traditional chinese medicineDevice

    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.

  • Moxibustion combined with lifestyle intervention.Device

    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.

  • lifestyle interventionDevice

    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.

Study groups in NCT04501198
Study groupRoleWhat they receive
Moxibustion with characteristic lifestyle intervention of TCMExperimentalParticipants 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.
Receives: Device: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine
moxibustion with lifestyle interventionExperimentalParticipants 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.
Receives: Device: Moxibustion combined with lifestyle intervention.
lifestyle interventionOtherParticipants 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.
Receives: Device: lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in waistline

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

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

Secondary outcomes (18)

  1. Changes in weight

    Body weight will be measured by a body composition analyzer (OMRON V.BODY).

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  2. 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.

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  3. 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).

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  4. Changes in basal metabolic value

    Basal metabolic value will be measured by a body composition analyzer (OMRON V.BODY).

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  5. Changes in hip circumference

    hip circumference will be measured at the level of maximum posterior extension of the buttocks.

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  6. 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 ).

    Measured: week 0,week 2,week 4,week 6,week 8,week 12

  7. Changes in fasting blood-glucose

    examined with the blood sample

    Measured: week 0, week 8

  8. Changes in fasting insulin

    examined with the blood sample

    Measured: week 0, week 8

  9. Changes in insulin resistance index insulin resistance index insulin resistance index

    examined with the blood sample

    Measured: week 0, week 8

  10. Changes in total cholesterol

    examined with the blood sample

    Measured: week 0, week 8

  11. Changes in triglyceride

    examined with the blood sample

    Measured: week 0, week 8

  12. Changes in low density lipoprotein

    examined with the blood sample

    Measured: week 0, week 8

  13. Changes in high-density lipoprotein

    examined with the blood sample

    Measured: week 0, week 8

  14. Changes in uric acid

    examined with the blood sample

    Measured: week 0, week 8

  15. Changes in blood pressure

    Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).

    Measured: week 0, week 8

  16. 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.

    Measured: week 0, week 8, week 12

  17. 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).

    Measured: week 0, week 8, week 12

  18. 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.

    Measured: week 0, week 8, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501198
Sponsor's protocol ID
202006009
Status last verified
Sep 2020
First submitted
23 Jul 2020
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: the data will be published in the form of public papers before January 2022 for public inquiries

Publications

  • 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.

    PubMed 30364290

  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PubMed 15364185

  • Freisling H, Arnold M, Soerjomataram I, O'Doherty MG, Ordonez-Mena JM, Bamia C, Kampman E, Leitzmann M, Romieu I, Kee F, Tsilidis K, Tjonneland 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.

    PubMed 28441380

  • 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.

    PubMed 27219496

  • Dalle Grave R, Calugi S, El Ghoch M. Lifestyle modification in the management of obesity: achievements and challenges. Eat Weight Disord. 2013 Dec;18(4):339-49. doi: 10.1007/s40519-013-0049-4. Epub 2013 Jul 27.

    PubMed 23893662

  • 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.

    PubMed 27299618

  • 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.

    PubMed 28199805

  • 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.

    PubMed 23736733

  • 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.

    PubMed 20039972

  • 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.

    PubMed 24149519

  • 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.

    PubMed 29358964

  • 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.

    PubMed 30902750

  • Wang LH, Huang W, Zhou W, Zhou L, Zhou XL, Zhou P, Yan Y, Zhou ZY, Wang H. Moxibustion combined with characteristic lifestyle intervention of Traditional Chinese Medicine in the treatment of abdominal obesity: A study protocol for a randomized controlled trial. Medicine (Baltimore). 2020 Oct 23;99(43):e22855. doi: 10.1097/MD.0000000000022855.

    PubMed 33120822

Questions about this trial

What is this clinical trial studying?

A study testing moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine, Moxibustion combined with lifestyle intervention. and lifestyle intervention in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhongyu Zhou, Professor (+86 18672308659, 2209447940@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in waistline (time frame: week 0,week 2,week 4,week 6,week 8,week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501198, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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