Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes in body weight
研究概览
简要总结
This is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus Intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.
详细描述
Obesity in childhood is associated with multiple cardiometabolic risk factors including hyperglycemia, dyslipidemia and hypertension, which predicts increased risk for developing obesity-driven complications in adulthood. Auricular acupuncture therapy is an intervention with purported success for the treatment of obesity. However, traditional intervention rarely has long-term success in children and adolescents. Low-carbohydrate diets have also been shown to reduce body weight and improve insulin sensitivity in children.
This is a three-month randomized controlled trial in children with gastric damp-heat obstruction, in order to explore the effects of traditional Chinese medicine auricular acupressure and intermittent carbohydrate restriction on cardiovascular metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least one of the following cardiometabolic risk factors: overweight or obesity, prediabetes, dyslipidemia or elevated blood pressure.
- •Traditional Chinese medical syndrome type is gastric heat and dampness obstruction syndrome.
排除标准
- •Diagnosis of obesity associated with genetic or endocrine diseases, including hypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamic obesity.
- •Participating in other clinical trials or have participated in other clinical trials in recent 3 months.
- •Diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.
结局指标
主要结局
Changes in body weight
时间窗: From baseline to one month after intervention
The body weight will be measured by fixed research staff at baseline and one month after intervention.
次要结局
- Changes in blood lipid ,liver and kidney function level(From baseline to three month after intervention)
- changes in the cumulative score of traditional Chinese medicine syndromes(From baseline to three month after intervention)
- Changes in body fat content(From baseline to three month after intervention)
- Changes in dietary and exercise data(From baseline to three month after intervention)
- Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure(From baseline to three month after intervention)
- Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc(From baseline to three month after intervention)
- Changes in Gut microbiota(From baseline to one month after intervention)