Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05227105
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-07
First Post:
2022-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PA Moves Trial - Patient Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 880}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Questionnaire', 'timeFrame': '12 months vs. baseline', '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.'}, {'measure': 'Objective accelerometry', 'timeFrame': '12 months vs. baseline', 'description': 'An accelerometer will be worn for one week to track physical activity.'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Questionnaire', 'timeFrame': '24 months vs. baseline; 24 months vs. 12 months', '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.'}, {'measure': 'Objective accelerometry', 'timeFrame': '24 months vs. baseline; 24 months vs. 12 months', 'description': 'An accelerometer will be worn for one week to track physical activity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity', 'Diabetes Mellitus, Type 2', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.', 'detailedDescription': "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.\n\nCompared 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.\n\nPrimary 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 - 75 at the time of enrollment\n* Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)\n* Physically inactive (defined as \\< 90 min/week of self-reported structured physical activity)\n* Able to speak, read, and understand the English language\n* 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\n* Must be able to provide and understand informed consent\n* Primary care patient of one of the participating providers\n* Self-report ability to walk ¼ mile\n* Access to a telephone\n\nExclusion Criteria:\n\n* 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\n* Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions\n* Evidence in the electronic medical record of an absolute contraindication for physical activity\n* Severe or advanced orthopedic conditions\n* Use of assistive devices for ambulation\n* Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT05227105', 'briefTitle': 'PA Moves Trial - Patient Participants', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Increasing Physical Activity in Rural Pennsylvanians: The PA Moves Trial', 'orgStudyIdInfo': {'id': 'STUDY22110037'}, 'secondaryIdInfos': [{'id': 'R01CA268017', 'link': 'https://reporter.nih.gov/quickSearch/R01CA268017', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Activity intervention', '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.', 'interventionNames': ['Behavioral: Physical Activity']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed intervention', 'description': 'Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.', 'interventionNames': ['Behavioral: Delayed intervention']}], 'interventions': [{'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'description': 'Physical activity will be encouraged up to an amount of 150 minutes per week.', 'armGroupLabels': ['Physical Activity intervention']}, {'name': 'Delayed intervention', 'type': 'BEHAVIORAL', 'description': 'Physical activity will be encouraged at the end of the trial.', 'armGroupLabels': ['Delayed intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Kathryn Schmitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kathryn Schmitz', 'investigatorAffiliation': 'University of Pittsburgh'}}}}