Clinical trial NCT03695016: Activity Prescription in Clinical Practice
Official title: Advancement of Physical Activity Prescription in Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Sedentary Lifestyle
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Aerobic activity
timeFrame: 10 days of recording at 0 and 3 months
measure: Change in Step counts
timeFrame: 10 days of recording at 0 and 3 months
measure: Change in sedentary behavior
timeFrame: 10 days of recording at 0 and 3 months
Secondary outcomes:
measure: self-efficacy
timeFrame: pre-intervention and 3 and 6 months post-intervention
measure: Referring physician- usability of physicians report
timeFrame: 3 months post-intervention
measure: Change in Aerobic Activity
timeFrame: 10 days of recording pre and post-intervention (3 and 6 months post)
measure: Change in Step counts
timeFrame: 10 days of recording pre and post-intervention (3 and 6 months post)
measure: Change in Sedentary behavior
timeFrame: 10 days of recording pre and post-intervention (3 and 6 months post)
measure: Patient experience
timeFrame: 3 and 6 months post-intervention
measure: Health-related Quality of Life- PROMIS-29 score
timeFrame: pre-intervention and 3 and 6 months post-intervention
measure: Participant cost
timeFrame: pre-intervention and 3 and 6 months post-intervention
measure: Perceived Health Score
timeFrame: pre-intervention and 3 and 6 months post-intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Bonny Rockette-Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockette-Wagner B, Fischer GS, Kriska AM, Conroy MB, Dunstan D, Roumpz C, McTigue KM. Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 3;9(11):e18891. doi: 10.2196/18891.