Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Urine volume (intervention)
研究概览
简要总结
The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.
详细描述
The study is a six-month ecological momentary assessment study of patients using the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors that disrupt routines during the 3-month intervention period, and monthly assessments of motivation and life events or stressors that disrupt routines in the three months following the end of intervention (months 4-6). The mini-sipIT intervention includes automated and manual tracking of fluid intake and lapse-contingent reminders to drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of symptomatic kidney stone in the past 5 years,
- •Age 18 or older,
- •Own an iOS or Android smart phone,
- •Proficient in English,
- •Capable of providing informed consent,
- •Willing to use the water bottle and companion app & receive text message reminders for 3 months,
- •Live in continental US.
排除标准
- •Pregnant or planning to become pregnant during the next 6 months,
- •Concurrently participating in other study involving fluid intake or diet,
- •Plan to have surgery in the next 6 months,
- •Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or
- •Active medical treatments that would impair protocol compliance.
研究组 & 干预措施
sipIT
Participants will receive an educational handout about physical activity, a connected water bottle with its companion mobile application. For months 1-3, participants will receive lapse-contingent reminders to drink delivered by text message.
干预措施: sipIT (Behavioral)
结局指标
主要结局
Urine volume (intervention)
时间窗: from baseline to the end of the intervention period (3 months)
Change in urine volume
次要结局
- Urine volume (maintenance)(from the end of the intervention period (3 months) to the maintenance change at 6 months)
研究者
David Conroy
Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology
University of Michigan