SKTA iWell21 Clinical Trial Protocol. This is a Randomized Control Trial of 500 Adult Participants Randomized to Two Arms: Control Arm: Self Directed Program (SDP), Intervention Arm: Dynamic On-line Interactive Technology (DOIT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Weight loss from baseline
研究概览
简要总结
This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.
The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.
详细描述
Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years old
- •overweight or obese men and women with BMI between 24 and 38, inclusive
- •concerned about weight/health (and motivated in losing weight)
- •stable medications for past 3 months
- •willing/able to use Web-based services
- •willingness not to use weight loss medications for the duration of the trial
- •able and willing to give informed consent and participate in the interventions
- •willing to come to three sessions and visits
- •willingness to be randomized to intervention or control group
排除标准
- •contraindication to weight loss (e.g., malignancy or other serious illness)
- •Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
- •Recent (within 6 months) cardiovascular event (MI or stroke)
- •current symptoms of angina
- •heart, renal, or liver disease (excluding kidney stone)
- •cancer or active neoplasm (excluding skin cancers)
- •hyperthyroidism
- •mental conditions that would preclude full participation
- •prior weight-loss (bariatric) surgery or plan for these procedures
- •liposuction surgery in past 12 months or plan for these procedures
- •recent weight loss in the past 3 months (>20 lbs)
- •use of prescription weight loss medication in 3 months prior to screening
- •current use of medications for treatment of psychosis or manic-depressive illness
结局指标
主要结局
Weight loss from baseline
时间窗: at 6 months
次要结局
- Blood pressure change from baseline(at 6 months)
- Triglyceride level change from baseline(at 6 months)
- High density lipoprotein level change from baseline(at 6 months)
- Physical activity adjustment from baseline(at 6months)