Activity Prescription in Clinical Practice
- Conditions
- Sedentary LifestylePhysical Activity
- Interventions
- Behavioral: ActiveGOALs
- Registration Number
- NCT03695016
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Intervention ActiveGOALs 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. Wait-listed Control ActiveGOALs 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.
- Primary Outcome Measures
Name Time Method Change in Aerobic activity 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 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 10 days of recording at 0 and 3 months Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer
- Secondary Outcome Measures
Name Time Method Change in Sedentary behavior 10 days of recording pre and post-intervention (3 and 6 months post) Change in objectively measured sedentary behavior from ActiGraph accelerometer
Referring physician- usability of physicians report 3 months post-intervention 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).
Change in Step counts 10 days of recording pre and post-intervention (3 and 6 months post) Change in objectively measured step counts from ActiGraph accelerometer
self-efficacy pre-intervention and 3 and 6 months post-intervention questionnaire developed for this study, uses a 10 point scale.
Health-related Quality of Life- PROMIS-29 score pre-intervention and 3 and 6 months post-intervention Promis 29- Likert scale based questionnaire that determines quality of life in 7 areas of health with 4 questions in each area.
Participant cost pre-intervention and 3 and 6 months post-intervention Cost survey questionnaire developed specifically for this study to determine health and personal monetary costs associated with participation in this study.
Change in Aerobic Activity 10 days of recording pre and post-intervention (3 and 6 months post) Change in objectively measured moderate-vigorous activity from ActiGraph accelerometer
Perceived Health Score pre-intervention and 3 and 6 months post-intervention EQ-VAX- Determines current perception of health on a 0-100 scale.
Patient experience 3 and 6 months post-intervention 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.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States