Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-27 @ 10:55 AM
Study NCT ID:
NCT04445168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Exercise Promotion in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate to vigorous physical activity (MVPA)', 'timeFrame': '12 months', 'description': 'Accelerometer-derived 7-day MVPA'}, {'measure': 'Moderate to vigorous physical activity (MVPA)', 'timeFrame': '24 months', 'description': 'Accelerometer-derived 7-day MVPA'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '12 months', 'description': 'Weight assessed from electronic medical records'}, {'measure': 'Weight', 'timeFrame': '24 months', 'description': 'Weight assessed from electronic medical records'}, {'measure': 'Systolic blood pressure', 'timeFrame': '12 months', 'description': 'Systolic blood pressure assessed from electronic medical records'}, {'measure': 'Systolic blood pressure', 'timeFrame': '24 months', 'description': 'Systolic blood pressure assessed from electronic medical records'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '12 months', 'description': 'Diastolic blood pressure assessed from electronic medical records'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '24 months', 'description': 'Diastolic blood pressure assessed from electronic medical records'}, {'measure': 'HbA1c', 'timeFrame': '12 months', 'description': 'HbA1c assessed from electronic medical records'}, {'measure': 'HbA1c', 'timeFrame': '24 months', 'description': 'HbA1c assessed from electronic medical records'}, {'measure': 'Health-related quality of life', 'timeFrame': '12 months', 'description': 'Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life'}, {'measure': 'Health-related quality of life', 'timeFrame': '24 months', 'description': 'Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Randomized trial', 'Primary care'], 'conditions': ['PreDiabetes', 'Diabetes', 'Sedentary Behavior']}, 'descriptionModule': {'briefSummary': 'Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAble to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,\n\nExclusion Criteria:\n\nCurrent use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,'}, 'identificationModule': {'nctId': 'NCT04445168', 'acronym': 'EPPC', 'briefTitle': 'Randomized Trial of Exercise Promotion in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes', 'orgStudyIdInfo': {'id': 'KPSC IRB#10106M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.', 'interventionNames': ['Behavioral: Telephone-based motivational interviews']}], 'interventions': [{'name': 'Telephone-based motivational interviews', 'type': 'BEHAVIORAL', 'description': '2-year telephone-based motivational interviews to increase physical activity.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '911010', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}