Effect of transcutaneous electrical nerve stimulation of T6 dermatome by a portable, simple and cost-effective novel device on appetite reduction and weight loss in obese individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- III. Body mass index in Kg/m2.
研究概览
简要总结
This will be a single arm experimental trial aimed to find the effect of a portable, simple and cost-effective novel device on appetite reduction and weight loss in obese patients. Compared to other devices which is cumbersome and patients usually visit hospital for the interventions, we will be using a new device which is feasible to use at home and workplace after proper guidance from the investigators.The interventions will be carried out for 1 month and all subjects will be followed up 4 weeks after final intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI > 30 kg/m2
- •Appetite level on VAS ≥ 3 (VAS is found to be a reliable and valid tool to measure appetite level and the whole method is described in procedure section, Livingstone et al., 2000)
- •Dietary treatment failure.
排除标准
- •Any known endocrine disease resulting in obesity
- •Evidence of metabolic, neurological, psychiatric, gynecological and cardiovascular disorder
- •Any evidence of infective or malignant conditions
- •Previous abdominal surgeries
- •Withdrawal of consent.
结局指标
主要结局
III. Body mass index in Kg/m2.
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
b.Fullness before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
I. Appetite :
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
a.Desire to eat before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
c.Hunger before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
II. Weight loss from pre-post intervention and follow-up
时间窗: 1. Before intervention | 2. Each week during intervention and till after 4 weeks of completion of treatment | 3. 4 weeks after completion of intervention
次要结局
- 1. Daily Caloric intake: Having patients their daily calories on ‘My fitness app’ on their smartphone.(1. Everyday before starting intevention to 4 weeks after final intervention.)