PA Moves Trial - Patient Participants

NCT ID: NCT05227105

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2027-12-31

Brief Summary

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

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.

Conditions

Overweight or Obesity; Diabetes Mellitus, Type 2; Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

Physical activity will be encouraged up to an amount of 150 minutes per week.

Delayed intervention

Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Group Type: PLACEBO_COMPARATOR

Delayed intervention

Intervention Type: BEHAVIORAL

Physical activity will be encouraged at the end of the trial.

Interventions

Physical Activity

Physical activity will be encouraged up to an amount of 150 minutes per week.

Intervention Type: BEHAVIORAL

Delayed intervention

Physical activity will be encouraged at the end of the trial.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Schmitz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R01CA268017

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY22110037

Identifier Type: -

Identifier Source: org_study_id