Overweight or ObesityNCT05227105
PA Moves Trial - Patient Participants
A study testing Physical Activity and Delayed intervention in people with Overweight or Obesity and Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to address physical inactivity in rural populations in Pennsylvania. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight or Obesity, Diabetes Mellitus, Type 2, Physical Inactivity
- What is being tested?
- Physical Activity and Delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Primary care patient of one of the participating providers
- Self-report ability to walk ¼ mile
- Access to a telephone
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Physical Activity, Delayed intervention
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Physical activity will be encouraged up to an amount of 150 minutes per week.
Delayed interventionBehavioural
Physical activity will be encouraged at the end of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity intervention | Active comparator | 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. Receives: Behavioral: Physical Activity |
| Delayed intervention | Placebo comparator | Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months. Receives: Behavioral: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months vs. baseline
Objective accelerometry
An accelerometer will be worn for one week to track physical activity.
Measured: 12 months vs. baseline
Secondary outcomes (2)
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.
Measured: 24 months vs. baseline; 24 months vs. 12 months
Objective accelerometry
An accelerometer will be worn for one week to track physical activity.
Measured: 24 months vs. baseline; 24 months vs. 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start23 May 2023
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathryn Schmitz, University of Pittsburgh
- Investigators
- Kathryn Schmitz, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227105
- Sponsor's protocol ID
- STUDY22110037
- Other IDs
- R01CA268017
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West SM, Meyer MRU, Patterson C, Ruffin MT, Calo W, Pagoto S, Conroy D, Doerksen S, Sciamanna CN, Gordon B, Garrow G, Werts-Pelter SJ, Schmitz KH. Increasing physical activity in rural Pennsylvanians: The PA moves trial study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2026 Jul;166:108348. doi: 10.1016/j.cct.2026.108348. Epub 2026 May 13.
PubMed 42134685
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial
- ClinicalTrials.gov ID
- NCT05227105
- Acronym / sponsor ID
- STUDY22110037
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 May 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity intervention | Active comparator | Behavioral: Physical ActivityFive 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. |
| Delayed intervention | Placebo comparator | Behavioral: Delayed interventionObjective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical activity will be encouraged up to an amount of 150 minutes per week. | Behavioural | Physical Activity intervention |
| Delayed interventionPhysical activity will be encouraged at the end of the trial. | Behavioural | Delayed intervention |
Primary outcome
Physical Activity Questionnaire
Time frame: 12 months vs. baseline
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
Time frame: 12 months vs. baseline
An accelerometer will be worn for one week to track physical activity.
2 secondary outcomes
Physical Activity Questionnaire
Time frame: 24 months vs. baseline; 24 months vs. 12 months
Objective accelerometry
Time frame: 24 months vs. baseline; 24 months vs. 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 42134685West SM, Meyer MRU, Patterson C, Ruffin MT, Calo W, Pagoto S, Conroy D, Doerksen S, Sciamanna CN, Gordon B, Garrow G, Werts-Pelter SJ, Schmitz KH. Increasing physical activity in rural Pennsylvanians: The PA moves trial study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2026 Jul;166:108348. doi: 10.1016/j.cct.2026.108348. Epub 2026 May 13.
- Individual participant dataSharing planned: No
Related trials for Overweight or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Schmitz, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Delayed intervention in people with Overweight or Obesity and Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Questionnaire (time frame: 12 months vs. baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.