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Clinical Trials/NCT03695016
NCT03695016
Completed
Not Applicable

Advancement of Physical Activity Prescription in Clinical Practice

University of Pittsburgh1 site in 1 country79 target enrollmentNovember 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Pittsburgh
Enrollment
79
Locations
1
Primary Endpoint
Change in Aerobic activity
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2018
End Date
March 30, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bonny Rockette-Wagner

Assistant Professor

University of Pittsburgh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 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

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

Secondary Outcomes

  • 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)

Study Sites (1)

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