Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Changes in waistline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in waistline
时间窗: 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).
次要结局
- Changes in uric acid(week 0, week 8)
- 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)
- Changes in waist-to-hip circumference ratio(week 0,week 2,week 4,week 6,week 8,week 12)
- Changes in fasting blood-glucose(week 0, week 8)
- Changes in fasting insulin(week 0, week 8)
- Changes in low density lipoprotein(week 0, week 8)
- Changes in high-density lipoprotein(week 0, week 8)
- Changes in insulin resistance index insulin resistance index insulin resistance index(week 0, week 8)
- Changes in total cholesterol(week 0, week 8)
- Changes in triglyceride(week 0, week 8)
- Changes in Conversion score of constitution characteristics(week 0, week 8, week 12)
- Changes in the IWQOL - Lite scale score(week 0, week 8, week 12)
- Changes in the Emotional and Psychological Assessment scale(week 0, week 8, week 12)
- Changes in blood pressure(week 0, week 8)
研究者
Wang Jian
professor
Hubei Hospital of Traditional Chinese Medicine