Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.
Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided into laser acupuncture and control group. A single-blind clinical trial will be conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After about 3 weeks of treatment, the differences of the subjects' body weight, body mass index, and waist circumference will be analyzed with ANOVA between laser acupuncture and control group.
详细描述
Objective
Gestational weight gain and weight retention at 1 year after delivery are associated with long-term obesity. The investigators aimed to investigate the effect of laser acupuncture therapy (LAT) on postpartum weight control.
Methods: The investigators randomly assigned 66 subjects with postpartum weight retention to a laser acupuncture group and control group. The subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25 (Tianshu), ST28 (Shuidao), ST40 (Fenglong), SP15 (Daheng), CV9 (Shuifen), and SP6 (Sanyinjiao) by using verum or sham laser acupuncture over 5 sessions per week. After 12 treatment sessions, the differences in the body mass index (BMI), body fat percentage (BFP), and waist-to-buttocks ratio (WBR) of the patients were analyzed, and compared between the laser acupuncture and control groups via analysis of variance, chi-square tests, and stepwise regression tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postpartum duration of <1 month;
- •body mass index (BMI) > 25;
- •age > 20 years;
- •did not use any other medications for weight loss during the study period; and
- •provided informed consent.
排除标准
- •presence of a pacemaker;
- •history of seizure or epilepsy;
- •taking immunosuppressant medication;
- •infectious disease of the skin;
- •taking medications for weight loss, including Chinese herbal preparations, during the study period;
- •receiving other treatment, including supplements, herbs, and medications for weight gain prior to entering the study;
- •comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would affect the findings;
- •unable to undergo LAT due to other medical conditions; and
- •lack of informed consent.
结局指标
主要结局
Body Mass Index (BMI)
时间窗: up to 3 weeks, 3 months after study completion
The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.
次要结局
- Body Fat Percentage (BFP)(up to 3 weeks)
- Waist-to-buttock Ratio (WBR)(up to 3 weeks)
研究者
Wen-Long Hu
Deputy director, Department of Chinese Medicine
Chang Gung Memorial Hospital