Activity Prescription in Clinical Practice
Sponsor:
University of Pittsburgh
Collaborators:
Information provided by (Responsible Party):
Bonny Rockette-Wagner，University of Pittsburgh
| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | October 2018 | ||
| Estimated Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Activity Prescription in Clinical Practice |
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| Official Title ICMJE | Advancement of Physical Activity Prescription in Clinical Practice |
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| Brief Summary | 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. |
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| Detailed Description | 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months. Masking: Interventional Masking Description: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. Primary Purpose: Prevention |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
80 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | October 31, 2019 | ||
| Estimated Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
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| Ages | 21 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Bonny Rockette-Wagner，University of Pittsburgh | ||
| Study Sponsor ICMJE | University of Pittsburgh | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Pittsburgh | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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