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临床试验/NCT03094858
NCT03094858撤回不适用

Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

University of Oklahoma0 个研究点开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Accelerometer-measured sedentary time

研究概览

简要总结

Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •A score of ≥ 4 on the REALM-SF85 indicating > 6th grade English literacy level, must be at least 18 years of age
  • •A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
  • •Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
  • •Able to attend all study visits, and possess a valid home address and a functioning telephone number.

排除标准

  • •Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.

研究组 & 干预措施

Comparison group

Active Comparator

Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior

干预措施: Wristband (Device)

Comparison group

Active Comparator

Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior

干预措施: Smartphone (Device)

Intervention group

Experimental

Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband

干预措施: Smartphone with prompts (Device)

Intervention group

Experimental

Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband

干预措施: Wristband (Device)

结局指标

主要结局

Accelerometer-measured sedentary time

时间窗: One week

Total accelerometer-measured time spent in sedentary activity

次要结局

  • Accelerometer-measured time spent in light, moderate, and vigorous activity(26 weeks)
  • Accelerometer-measured sedentary breaks(26 weeks)
  • Accelerometer-measured total active time(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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