Activity Prescription in Clinical Practice

Physical Activity Clinical Trial

Official title:

Advancement of Physical Activity Prescription in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695016
• Other study ID #: PRO17120265
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: October 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aerobic activity	Objectively measured change in moderate-vigorous activity between 0 and 3 months using ActiGraph accelerometer	10 days of recording at 0 and 3 months
Primary	Change in Step counts	Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer	10 days of recording at 0 and 3 months
Primary	Change in sedentary behavior	Objectively measured change in sedentary behavior between 0 and 3 months using ActiGraph accelerometer	10 days of recording at 0 and 3 months
Secondary	self-efficacy	questionnaire developed for this study, uses a 10 point scale.	pre-intervention and 3 and 6 months post-intervention
Secondary	Referring physician- usability of physicians report	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).	3 months post-intervention
Secondary	Change in Aerobic Activity	Change in objectively measured moderate-vigorous activity from ActiGraph accelerometer	10 days of recording pre and post-intervention (3 and 6 months post)
Secondary	Change in Step counts	Change in objectively measured step counts from ActiGraph accelerometer	10 days of recording pre and post-intervention (3 and 6 months post)
Secondary	Change in Sedentary behavior	Change in objectively measured sedentary behavior from ActiGraph accelerometer	10 days of recording pre and post-intervention (3 and 6 months post)
Secondary	Patient experience	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.	3 and 6 months post-intervention
Secondary	Quality of Life	Promis 29- Likert scale based questionnaire that determines quality of life in 7 areas of health with 4 questions in each area.	pre-intervention and 3 and 6 months post-intervention
Secondary	Participant cost	Cost survey questionnaire developed specifically for this study to determine health and personal monetary costs associated with participation in this study.	pre-intervention and 3 and 6 months post-intervention
Secondary	Perceived Health Score	EQ-VAX- Determines current perception of health on a 0-100 scale.	pre-intervention and 3 and 6 months post-intervention