NCT04408586已完成4 期
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Body Weight Change
研究概览
简要总结
Researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phentermine - Topiramate Extended Release group
Active Comparator
干预措施: Phentermine-Topiramate Extended Release (Drug)
Phentermine - Topiramate Extended Release group
Active Comparator
干预措施: Online support system (Other)
Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
Placebo Group
Placebo Comparator
干预措施: Online support system (Other)
结局指标
主要结局
Body Weight Change
时间窗: baseline, 3 months
Change in weight calculated in kilograms.
次要结局
- Change in Calories(baseline, 12 months)
- Exercise Sessions(12 months)
- Tracker Usage(12 months)
- Change in SF-12 Physical Score (Health-related Quality Quality of Life)(baseline, 12 months)
- Change in Step Count(baseline,12 months)
- Change in SF-12 Mental Score (Health-related Quality Quality of Life)(baseline, 12 months)
- Body Weight Change(baseline, 12 months)
研究者
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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