PA Moves Trial - Patient Participants

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05227105
• Other study ID #: STUDY22110037
• Secondary ID: R01CA268017
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 880
• Est. completion date: December 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 and over 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
• Scheduled for a clinic appointment with their provider during the study recruitment period
• Negative responses for each of the Physical Activity Readiness Questionnaire (PAR-Q) questions
• Self-report ability to walk ¼ mile

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Physical Activity
Physical activity will be encouraged up to an amount of 150 minutes per week.
• Delayed intervention
Physical activity will be encouraged at the end of the trial.

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Objective accelerometry	An accelerometer will be worn for one week to track physical activity.	12 months vs. baseline
Secondary	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
Secondary	Objective accelerometry	An accelerometer will be worn for one week to track physical activity.	24 months vs. baseline; 24 months vs. 12 months