Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT02044705
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2014-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Active and Healthy Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in parent weight', 'timeFrame': 'Baseline and week 10'}], 'primaryOutcomes': [{'measure': 'Changes from baseline in body mass index (BMI)', 'timeFrame': 'Baseline and at week 10', 'description': 'Change from baseline are assessed from measured height and weight'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in blood glucose', 'timeFrame': 'Baseline and week 10'}, {'measure': 'Changes from baseline in fasting lipids', 'timeFrame': 'Baseline and week 10'}, {'measure': 'Change from baseline in insulin resistance', 'timeFrame': 'Baseline and week 10'}, {'measure': 'Change from baseline in blood pressure', 'timeFrame': 'Baseline and week 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Health Care', 'Pediatrics', 'Obesity', 'Overweight', 'Clinical trial', 'Hispanic Americans', 'Family', 'Body mass index'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 5-12 years\n* Body mass index greater than or equal to the 85th percentile for age and sex\n* Patients seen at Contra Costa County clinics participating in Active and Healthy Families\n* Spanish speaking\n* Parent of participant\n\nExclusion Criteria:\n\n* Previous participation in Active and Healthy Families'}, 'identificationModule': {'nctId': 'NCT02044705', 'acronym': 'AHF', 'briefTitle': 'Impact of Active and Healthy Families', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers', 'orgStudyIdInfo': {'id': '2012-07-4508 A'}, 'secondaryIdInfos': [{'id': '033728', 'type': 'OTHER_GRANT', 'domain': 'Safeway Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family group sessions', 'description': 'Active and Healthy Families', 'interventionNames': ['Behavioral: Active and Healthy Families']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Controls may participate in Active and Healthy Families after the study'}], 'interventions': [{'name': 'Active and Healthy Families', 'type': 'BEHAVIORAL', 'description': 'Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).', 'armGroupLabels': ['Family group sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94565', 'city': 'Pittsburg', 'state': 'California', 'country': 'United States', 'facility': 'Pittsburg Health Center', 'geoPoint': {'lat': 38.02798, 'lon': -121.88468}}, {'zip': '94806', 'city': 'San Pablo', 'state': 'California', 'country': 'United States', 'facility': 'West County Health Center', 'geoPoint': {'lat': 37.96215, 'lon': -122.34553}}], 'overallOfficials': [{'name': 'Kristine A Madsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}