PA Moves Trial - Patient Participants

University of Pittsburgh

Status: Invitation-only

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

Treatments: Behavioral: Delayed intervention; Behavioral: Physical Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05227105

STUDY22110037

R01CA268017 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

880 participants in 2 patient groups, including a placebo group

Physical Activity intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity

Delayed intervention

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Delayed intervention