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

NCT04501198 | Unknown DMC

• 1 other identifier: 202006009
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

abdominal obesity; moxibustion; characteristic lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Changes in weight

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

• Changes in body mass index

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

• Changes in body fat percentage

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

• Changes in basal metabolic value

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

• Changes in hip circumference

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

Study Arms (3)

Moxibustion with characteristic lifestyle intervention of TCM

EXPERIMENTAL

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

moxibustion with lifestyle intervention

EXPERIMENTAL

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.

lifestyle intervention

OTHER

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

Interventions

moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine 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. 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 with characteristic lifestyle intervention of TCM

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.

moxibustion with lifestyle intervention

lifestyle intervention DEVICE

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead
• Shanxi Provincial Hospital of Traditional Chinese Medicine: collaborator
• Shenzhen Bao'an Traditional Chinese Medicine Hospital Group: collaborator
• Wuhan Hospital of Traditional Chinese Medicine: collaborator
• Xiangyang Hospital of Traditional Chinese Medicine: collaborator

Related Publications (13)

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  PMID: 30902750 BACKGROUND

• 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.

  PMID: 33120822 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhongyu Zhou, Professor

  Hubei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongyu Zhou, Professor

CONTACT

+86 18672308659; 2209447940@qq.com

Wei Huang, Professor

CONTACT

+86 13986083982; 13986083982@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 6, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09