Smart Technology for Weight Loss and Metabolic Health- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in body weight in kg
研究概览
简要总结
The study will evaluate whether a technology-based lifestyle intervention program using primarily a smartphone platform is an acceptable and effective way for treating obesity. The goal of the program is to achieve weight loss and enhance the health of overweight or obese subjects by improving their diet and activity via smartphone applications as compared with conventional in-person weight management programs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese BMI 25-42 kg/m2
- •Employed in sedentary occupations
- •Own a personal smartphone with unlimited data plan or >4 GigaByte data
- •Proficient with use of smartphone applications and technology with current daily usage
- •Ability to engage in moderate intensity exercise
- •Weight stability for the last 2 months
- •Participants must be willing to comply with all study-related procedures
排除标准
- •Current or planned pregnancy
- •Cardiovascular, pulmonary, renal disease, joint disease
- •Uncontrolled thyroid disease
- •History of eating disorders, psychiatric disease
- •History of substance abuse or dependence in the last 1 year
- •Shift work
- •Previous weight loss surgery
- •Use of weight loss drugs/diet/program in the last 6 weeks
- •Inability to increase walking as a form of exercise and to engage in moderate intensity exercise
- •Other conditions or medications that affect body weight/appetite/metabolism
- •Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation
- •Incapable of adhering with an intensive lifestyle intervention using technology and smartphone applications
研究组 & 干预措施
Smart Technology Group
The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.
干预措施: Standard Weight Management Visits (Behavioral)
Smart Technology Group
The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.
干预措施: Wearable technology, smartscale (Device)
Smart Technology Group
The Smart Technology Group will receive a technology-based lifestyle intervention program which uses wearable technology, smartscales and smartphone applications to track and deliver feedback on caloric expenditure, physical activity, caloric intake and body weight. Participants will receive information through smartphone applications on strategies to make changes to their diet, physical activity, and weight-related behaviors along with standard 3 monthly in-person weight management visits.
干预措施: Smartphone applications (Behavioral)
Standard Weight Management Group
The Standard Weight Management Group will receive 3 monthly in-person weight management visits during which they will receive standard of care lifestyle recommendations in accordance with the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guideline.
干预措施: Standard Weight Management Visits (Behavioral)
结局指标
主要结局
Change in body weight in kg
时间窗: 6 months
次要结局
- Change from baseline blood pressure(12 months)
- Change from baseline waist circumference(12 months)
- Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR)(6 months)
- Change from baseline hemoglobin A1c(6 months)
- Change from baseline plasma triglycerides(6 months)
- Change from baseline body weight in kg(12 months)
- Change in Quality of Life(6 months after receiving the intervention)
- Change in insulin resistance by homeostasis model assessment (HOMA-IR)(12 months compared to baseline and 6 months after receiving the intervention)
- Change in hemoglobin A1c(12 months compared to baseline and 6 months after receiving the intervention and from baseline)
- Change in plasma triglycerides(12 months compared to baseline and 6 months after receiving the intervention)