Activity Prescription in Clinical Practice

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advancement of Physical Activity Prescription in Clinical Practice

Conditions
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Physical Activity, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: ActiveGOALs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>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<br>* 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.<br>|
| Other: Wait-listed Control<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 |