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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Sedentary Lifestyle
• Intervention / Treatment: Behavioral: ActiveGOALs

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: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-efficacy	questionnaire developed for this study, uses a 10 point scale.	pre-intervention and 3 and 6 months post-intervention
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
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)
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)
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)
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
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
Perceived Health Score	EQ-VAX- Determines current perception of health on a 0-100 scale.	pre-intervention and 3 and 6 months post-intervention
Health-related Quality of Life- PROMIS-29 score	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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Bonny Rockette-Wagner, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PRO17120265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No