Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-04-25 @ 12:38 AM
Study NCT ID:
NCT03028935
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Baseline up to post intervention, up to 7 months', 'description': 'Mean and standard deviation will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Change in fitness level as assessed by the 6 minute walk test', 'timeFrame': 'Baseline up to post intervention, up to 7 months', 'description': 'The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated.'}]}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.\n\nII. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.\n\nOUTLINE:\n\nPhase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.\n\nPhase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).\n\nINTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phase I:\n* Bilingual Latina\n* Live in the community\n* Phase II:\n* Latina\n* Currently non-active (exercise two days or less per week)\n* Overweight or obese (body mass index \\[BMI\\] of 24 or greater)\n\nExclusion Criteria:\n\n* A medical condition that precludes moderate-vigorous physical activity as determined by health care provider\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03028935', 'briefTitle': 'Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas', 'orgStudyIdInfo': {'id': 'IRB00011637'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01321', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'IRB00011637', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}, {'id': 'P30CA069533', 'link': 'https://reporter.nih.gov/quickSearch/P30CA069533', 'type': 'NIH'}, {'id': 'R03CA197657', 'link': 'https://reporter.nih.gov/quickSearch/R03CA197657', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (exercise, nutrition education program)', 'description': 'Exercise Intervention \\& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Behavioral: Nutritional Intervention']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Undergo instructor-led exercise program', 'armGroupLabels': ['Prevention (exercise, nutrition education program)']}, {'name': 'Nutritional Intervention', 'type': 'BEHAVIORAL', 'description': 'Undergo instructor-led nutritional education program', 'armGroupLabels': ['Prevention (exercise, nutrition education program)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Cynthia Perry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cynthia Perry', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}