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临床试验/NCT04445168
NCT04445168进行中(未招募)不适用

Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2020年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
451
试验地点
1
主要终点
Moderate to vigorous physical activity (MVPA)

研究概览

简要总结

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,

排除标准

  • Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,

研究组 & 干预措施

Usual Care

No Intervention

Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.

Intervention

Experimental

Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.

干预措施: Telephone-based motivational interviews (Behavioral)

结局指标

主要结局

Moderate to vigorous physical activity (MVPA)

时间窗: 24 months

Accelerometer-derived 7-day MVPA

Moderate to vigorous physical activity (MVPA)

时间窗: 12 months

Accelerometer-derived 7-day MVPA

次要结局

  • Weight(24 months)
  • HbA1c(24 months)
  • Systolic blood pressure(24 months)
  • Health-related quality of life(24 months)
  • Diastolic blood pressure(24 months)
  • Weight(12 months)
  • Systolic blood pressure(12 months)
  • Diastolic blood pressure(12 months)
  • HbA1c(12 months)
  • Health-related quality of life(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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