- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05319821
PA Moves Trial - PCP Participants
Increasing Physical Activity in Rural Pennsylvanians: PCP Participants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People living in rural areas are diagnosed and die from cancer at higher rates than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.
Compared to people living in cities, people living in rural areas tend to be less physically active. They're also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.
PCPs and their staff can identify a patient's need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.
The purpose of this study is to determine if an ECHO intervention will impact the likelihood that PCPs will refer patients to the MoveLine for physical activity coaching.
Approximately 32-48 providers will take part in this research study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary care providers or adjunct faculty from Primary Health Network (PHN) or UPMC clinics serving rural populations
- Must be able to provide and understand informed consent
Exclusion Criteria:
1. Primary care providers or adjunct faculty NOT from PHN or UPMC clinics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Intervention
PCP participants in the practice cohort or the intervention group will receive the ECHO46 intervention via real-time, interactive videoconferencing through Zoom sessions held once weekly for 4 weeks (4 sessions total) at regularly scheduled times convenient to providers.
Session topics will focus on training PCP participants to assess, advise, and refer patients to be more physically active, as well as provide evidence-based strategies they can use to supplement and sustain their communication efforts.
|
Active Intervention
|
|
Active Comparator: Delayed Intervention
PCP participants will be offered the intervention in year 5.
|
Delayed Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Likelihood of patient referral
Time Frame: Through study completion, an average of 5 years
|
Percentage of participating primary care providers referring their patients to a community-level, telephone-based physical activity counseling service assessed through the EMR of their participating patients
|
Through study completion, an average of 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PAQ-M
Time Frame: Baseline intervention group vs. Baseline delayed intervention group
|
The 11-question Morgenstern Physical Activity Questionnaire (PAQ-M) is a self-report of physical activity resulting from recreational activities, exercises, home or work activities, and chores.
|
Baseline intervention group vs. Baseline delayed intervention group
|
|
Estimated average metabolic equivalents expended daily
Time Frame: 1 week at baseline
|
Daily metabolic equivalents collected using an accelerometer from Actigraph
|
1 week at baseline
|
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Estimated metabolic equivalents expended weekly
Time Frame: 1 week at baseline
|
Weekly metabolic equivalents collected using an accelerometer from Actigraph, expressed in hours/week
|
1 week at baseline
|
|
Time in Sleep
Time Frame: 1 week at baseline
|
Weekly time in sleep collected using an accelerometer from Actigraph
|
1 week at baseline
|
|
Sedentary Time
Time Frame: 1 week at baseline
|
Weekly sedentary time collected using an accelerometer from Actigraph
|
1 week at baseline
|
|
Low physical activity
Time Frame: 1 week at baseline
|
Weekly low physical activity collected using an accelerometer from Actigraph
|
1 week at baseline
|
|
Moderate physical activity
Time Frame: 1 week at baseline
|
Weekly moderate physical activity collected using an accelerometer from Actigraph
|
1 week at baseline
|
|
Vigorous physical activity
Time Frame: 1 week at baseline
|
Weekly vigorous physical activity collected using an accelerometer from Actigraph
|
1 week at baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn Schmitz, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22110036
- R01CA268017 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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