Clinical trial NCT04501198: Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: abdominal obesity
moxibustion
characteristic lifestyle intervention
Lead sponsor: Hubei Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial Hospital of Traditional Chinese Medicine
name: Shenzhen Bao'an Traditional Chinese Medicine Hospital Group
name: Wuhan Hospital of Traditional Chinese Medicine
name: Xiangyang Hospital of Traditional Chinese Medicine
First posted: 2020-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in waistline
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
Secondary outcomes:
measure: Changes in weight
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in body mass index
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in body fat percentage
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in basal metabolic value
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in hip circumference
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in waist-to-hip circumference ratio
timeFrame: week 0,week 2,week 4,week 6,week 8,week 12
measure: Changes in fasting blood-glucose
timeFrame: week 0, week 8
measure: Changes in fasting insulin
timeFrame: week 0, week 8
measure: Changes in insulin resistance index insulin resistance index insulin resistance index
timeFrame: week 0, week 8
measure: Changes in total cholesterol
timeFrame: week 0, week 8
measure: Changes in triglyceride
timeFrame: week 0, week 8
measure: Changes in low density lipoprotein
timeFrame: week 0, week 8
measure: Changes in high-density lipoprotein
timeFrame: week 0, week 8
measure: Changes in uric acid
timeFrame: week 0, week 8
measure: Changes in blood pressure
timeFrame: week 0, week 8
measure: Changes in Conversion score of constitution characteristics
timeFrame: week 0, week 8, week 12
measure: Changes in the IWQOL - Lite scale score
timeFrame: week 0, week 8, week 12
measure: Changes in the Emotional and Psychological Assessment scale
timeFrame: week 0, week 8, week 12
Other outcomes:
Locations:
Study officials:
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Zhongyu Zhou, Professor
role: PRINCIPAL_INVESTIGATOR
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