Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT01912859
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next Steps: a Community-led Solution to Address Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintain or lower body mass index', 'timeFrame': 'up to 4 months', 'description': 'Body mass index.'}, {'measure': 'Frequency and intensity of physical activity', 'timeFrame': 'up to 4 months', 'description': 'Frequency and intensity of physical activity'}, {'measure': 'Frequency of intake of healthful foods and reduction of unhealthful foods;', 'timeFrame': 'up to 4 months', 'description': 'Frequency of intake of healthful foods and reduction of unhealthful foods;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of Next Steps pilot intervention is to develop and test a new program designed to help low-income multiethnic families with overweight or obese children achieve long-term maintenance of healthful behaviors following completion of Hennepin County Medical Center's (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).", 'detailedDescription': "Next Steps is a community based pilot intervention study conducted in collaboration between community leaders, the University of Minnesota, Hennepin County Medical Center (HCMC) and The Family Partnership. The study collaborators will develop and test a new program designed to help low-income multiethnic families with overweight or obese children achieve long-term maintenance of healthful behaviors following completion of HCMC's 16-week intensive obesity management course (Taking Steps Together (TST)). Next Steps, the focus of this study, will comprise a network of parent-led, community-based health maintenance programs that will be offered to TST graduate families.\n\nProject Aims:\n\nAim 1: Establish a core parent leadership group and health maintenance program network that is self-sustaining and can serve the community for years to come.\n\nAim 2: Test the feasibility, acceptability and sustainability of the Next Steps programs.\n\nAim 3: Assess the impact of the Next Steps programs on helping participant families sustain or improve healthful behaviors and achieve or maintain healthy body mass index (BMI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Families that are graduates of the Taking Step Together program.\n* Families with at least one overweight or obese child between the ages of 7-17.\n* Family members of all ages who have graduated from the Taking Steps Together program will be included in the study.\n\nExclusion Criteria:\n\n* Families who are not graduates of the Taking Steps Together program.\n* Families who do not have one child that is between the ages of 7-17 and who is overweight or obese'}, 'identificationModule': {'nctId': 'NCT01912859', 'briefTitle': 'Next Steps: a Community-led Solution to Address Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Next Steps: a Community-led Solution to Sustaining Healthy Behaviors in Families Addressing Childhood Obesity', 'orgStudyIdInfo': {'id': '1303S29343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition/physical activity intervention', 'description': 'The intervention, Next Steps, comprises a network of community-led health maintenance programs offered to graduates of an initial intensive obesity course. These health maintenance programs will aim to help participants maintain and improve healthful behaviors and body mass indices.', 'interventionNames': ['Behavioral: Nutrition/physical activity intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants in the "No Intervention" arm will not have access to the Next Steps programs and will receive only usual care through their health care clinic.'}], 'interventions': [{'name': 'Nutrition/physical activity intervention', 'type': 'BEHAVIORAL', 'description': 'Nutrition/physical activity intervention', 'armGroupLabels': ['Nutrition/physical activity intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chrisa Arcan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'John D Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}, {'name': 'Maria Galvan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Leader'}, {'name': 'Natividad Contreras', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Leader'}, {'name': 'Aurolivia Reyes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Leader'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hennepin County Medical Center, Minneapolis', 'class': 'OTHER'}, {'name': 'The Family Partnership, Minneapolis', 'class': 'UNKNOWN'}, {'name': 'Community Leaders, Minneapolis, Richfield', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}