PA Moves Trial - Patient Participants

Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Overweight or Obesity; Physical Inactivity
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Delayed intervention

Detailed Description

People living in rural areas are diagnosed and die from cancer at higher rate 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.

Primary care providers 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 referring inactive patients to the MoveLine will help them to be more physically active over time. Approximately 880 people will take part in this research in rural areas of Pennsylvania.

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 - 75 at the time of enrollment
• Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)
• Physically inactive (defined as < 90 min/week of self-reported structured physical activity)
• Able to speak, read, and understand the English language
• Resides in a rural area of Pennsylvania with a Rural Urban Continuum Code (RUCC) 4 - 9 or Rural-Urban Commuting Area (RUCA) code 4 - 10
• Must be able to provide and understand informed consent
• Primary care patient of one of the participating providers
• Self-report ability to walk ¼ mile
• Access to a telephone

Exclusion Criteria:

• Cardiac exclusion criteria: Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, acute pericarditis, acute endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, or acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
• Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions
• Evidence in the electronic medical record of an absolute contraindication for physical activity
• Severe or advanced orthopedic conditions
• Use of assistive devices for ambulation
• Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Activity intervention; Five physical activity coaching calls with MoveLine and weekly physical activity. Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.	Behavioral: Physical Activity; Physical activity will be encouraged up to an amount of 150 minutes per week.
Placebo Comparator: Delayed intervention; Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.	Behavioral: Delayed intervention; Physical activity will be encouraged at the end of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Questionnaire	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.	12 months vs. baseline
Objective accelerometry	An accelerometer will be worn for one week to track physical activity.	12 months vs. baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Questionnaire	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.	24 months vs. baseline; 24 months vs. 12 months
Objective accelerometry	An accelerometer will be worn for one week to track physical activity.	24 months vs. baseline; 24 months vs. 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathryn Schmitz, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: STUDY22110037; R01CA268017 (U.S. NIH Grant/Contract)

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