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Activity Prescription in Clinical Practice

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合作者:
信息的提供 (责任方):
Bonny Rockette-Wagner,University of Pittsburgh
September 28, 2018
October 3, 2018
October 3, 2018
October 2018
July 31, 2019   (主要结果测量的最终数据收集日期)
Change in Aerobic activity[ Time Frame: 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 Step counts[ Time Frame: 10 days of recording at 0 and 3 months ]
Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer

Change in sedentary behavior[ Time Frame: 10 days of recording at 0 and 3 months ]
Objectively measured change in sedentary behavior between 0 and 3 months using ActiGraph accelerometer

与当前相同
  • self-efficacy[ Time Frame: pre-intervention and 3 and 6 months post-intervention ]
    questionnaire developed for this study, uses a 10 point scale.
  • Referring physician- usability of physicians report[ Time Frame: 3 months post-intervention ]
    Physician satisfaction with study reports using questionnaire developed for this study. Several likert scale-based questions to determine satisfaction with different aspects of the report (design, readability, and aspects of usability).
  • Change in Aerobic Activity[ Time Frame: 10 days of recording pre and post-intervention (3 and 6 months post) ]
    Change in objectively measured moderate-vigorous activity from ActiGraph accelerometer
  • Change in Step counts[ Time Frame: 10 days of recording pre and post-intervention (3 and 6 months post) ]
    Change in objectively measured step counts from ActiGraph accelerometer
  • Change in Sedentary behavior[ Time Frame: 10 days of recording pre and post-intervention (3 and 6 months post) ]
    Change in objectively measured sedentary behavior from ActiGraph accelerometer
  • Patient experience[ Time Frame: 3 and 6 months post-intervention ]
    patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions.
  • Quality of Life[ Time Frame: pre-intervention and 3 and 6 months post-intervention ]
    Promis 29- Likert scale based questionnaire that determines quality of life in 7 areas of health with 4 questions in each area.
  • Participant cost[ Time Frame: pre-intervention and 3 and 6 months post-intervention ]
    Cost survey questionnaire developed specifically for this study to determine health and personal monetary costs associated with participation in this study.
  • Quality of Life[ Time Frame: pre-intervention and 3 and 6 months post-intervention ]
    EQ-VAX- Determines current perception of health on a 0-100 scale.
 
Activity Prescription in Clinical Practice
Advancement of Physical Activity Prescription in Clinical Practice

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.

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.
Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
盲法: Interventional
盲法描述: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.
主要目的: Prevention
  • Behavioral: ActiveGOALs
    13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.
  • Experimental: Immediate Intervention
    Participants will receive the ActiveGOALS 13 week, online self-directed intervention for increasing aerobic physical activity and decreasing time spent sitting. The intervention is based on social-cognitive theory models of behavior changes and utilizes barrier recognition, problem solving, and monitoring of behavior to initiate behavior change. They will also receive weekly feedback from a coach and be provided with online, paper, and wearable tracking devices. They will also be provided with links to tools that support physical activity.
  • Other: Wait-listed Control
    This group will receive a monthly newsletter with general health advice during the wait period (3 months). After the three month follow-up visit/ collection of outcomes they will be offered the ActiveGOALS intervention in its entirety.
 
Not yet recruiting
80
与当前相同
October 31, 2019
July 31, 2019   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
参与研究的性别: All
最小年龄:21 Years ,最大年龄:70 Years  
没有
 
Yes
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: Undecided
Bonny Rockette-Wagner,University of Pittsburgh
University of Pittsburgh
Principal Investigator: Bonny Rockette-Wagner, PhD University of Pittsburgh
University of Pittsburgh
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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