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临床试验/NCT03695016
NCT03695016已完成不适用

Advancement of Physical Activity Prescription in Clinical Practice

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2018年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
2
主要终点
Change in Aerobic activity

研究概览

简要总结

Most adults do not achieve the US aerobic physical activity (PA) guidelines (≥150 minutes/week of at least moderate intensity PA). Inadequate PA is considered a major risk factor for cardio-metabolic diseases and other poor health outcomes. Recommendations now endorse PA in reducing risk for certain diseases. Unfortunately, low PA levels are seldom identified and treated within clinical practice. This study will build on previous prevention efforts by focusing on the identifying and treating low PA levels in adults clinical care patients and referring them to an intervention that is feasible for delivery through clinical care.

详细描述

This study involves designing/ implementing a patient-centered, individually-focused physical activity (PA) intervention designed for integration into clinical care. We will recruit adult patients (aged 21-70; n=80) from the general internal medicine practice of a local health system who are not meeting the US aerobic activity goal of 150 minutes/ week of at least moderate intensity PA and who can safely increase PA without supervision. As low PA levels have been associated with numerous poor health outcomes, the primary intervention goal will be achievement of the US PA goal. A secondary goal will be to reduce sedentary behavior (SED), which is related to poor health outcomes (independent of PA achievement). Intervention materials will be developed using a patient/provider centered approach and delivered weekly over 3 months via an existing online platform with participants self-tracking behavior outcomes will be examined using a three month wait-listed control design in which all participants will eventually receive the intervention.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Participants and their referring physician will be aware of participant randomization. Only the intervention coach, who will also notify the participants of their assignment will be aware of the assignments; other study staff and the investigator will be masked.

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • not meeting the recommended levels of aerobic PA and have been identified by their primary care provider (PCP) as able to increase their PA without supervision.

排除标准

  • Participated in a goal setting intervention for physical activity or a translation of the Diabetes Prevention Program within the last 2 years.
  • Non-ambulatory or planning a procedure that will cause them to be non-ambulatory in the next 6 months
  • Pregnant or planning a pregnancy in the next 6 months
  • Need a way to access to the internet-based platform, at least a 6th grade reading level.

结局指标

主要结局

Change in Aerobic activity

时间窗: 10 days of recording at 0 and 3 months

Objectively measured change in moderate-vigorous activity between 0 and 3 months using ActiGraph accelerometer

Change in sedentary behavior

时间窗: 10 days of recording at 0 and 3 months

Objectively measured change in sedentary behavior between 0 and 3 months using ActiGraph accelerometer

Change in Step counts

时间窗: 10 days of recording at 0 and 3 months

Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer

次要结局

  • Change in Sedentary behavior(10 days of recording pre and post-intervention (3 and 6 months post))
  • Referring physician- usability of physicians report(3 months post-intervention)
  • Change in Step counts(10 days of recording pre and post-intervention (3 and 6 months post))
  • self-efficacy(pre-intervention and 3 and 6 months post-intervention)
  • Health-related Quality of Life- PROMIS-29 score(pre-intervention and 3 and 6 months post-intervention)
  • Participant cost(pre-intervention and 3 and 6 months post-intervention)
  • Change in Aerobic Activity(10 days of recording pre and post-intervention (3 and 6 months post))
  • Perceived Health Score(pre-intervention and 3 and 6 months post-intervention)
  • Patient experience(3 and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonny Rockette-Wagner

Assistant Professor

University of Pittsburgh

研究点 (2)

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