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PA Moves Trial - Patient Participants

Primary Purpose

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

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Activity

Delayed intervention

About this trial

This is an interventional prevention trial for Overweight or Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 county 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 county of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)

Sites / Locations

UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Physical Activity intervention

Delayed intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Objective accelerometry

An accelerometer will be worn for one week to track physical activity.

Secondary Outcome Measures

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.

Objective accelerometry

An accelerometer will be worn for one week to track physical activity.

Full Information

NCT ID

NCT05227105

First Posted

January 27, 2022

Last Updated

June 4, 2023

Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05227105

Brief Title

PA Moves Trial - Patient Participants

Official Title

Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 23, 2023 (Actual)

Primary Completion Date

August 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity intervention

Arm Type

Active Comparator

Arm 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.

Arm Title

Delayed intervention

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Delayed intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Physical Activity Questionnaire

Description

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.

Time Frame

12 months vs. baseline

Title

Objective accelerometry

Description

An accelerometer will be worn for one week to track physical activity.

Time Frame

12 months vs. baseline

Secondary Outcome Measure Information:

Title

Physical Activity Questionnaire

Description

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.

Time Frame

24 months vs. baseline; 24 months vs. 12 months

Title

Objective accelerometry

Description

An accelerometer will be worn for one week to track physical activity.

Time Frame

24 months vs. baseline; 24 months vs. 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn Schmitz, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15219

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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PA Moves Trial - Patient Participants

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