Physical Activity, Sedentary Lifestyle
Conditions
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.
Interventions
BEHAVIORALActiveGOALs
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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants and their referring physician will be aware of participant randomization. Only the intervention coach, who will also notify the participants of their assignment will be aware of the assignments; other study staff and the investigator will be masked.
Intervention model description
3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| self-efficacy | pre-intervention and 3 and 6 months post-intervention | questionnaire developed for this study, uses a 10 point scale. |
| 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. |
| Perceived Health Score | pre-intervention and 3 and 6 months post-intervention | EQ-VAX- Determines current perception of health on a 0-100 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. |
| 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 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 |
Countries
United States
Outcome results
None listed