Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-28 @ 6:03 AM
Study NCT ID:
NCT00993434
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2009-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Educational Materials on Family Behavior
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Child'], 'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.', 'detailedDescription': 'Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet \\& Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with a BMI greater than or equal to 85% along with a parent.\n* All subjects must speak English.\n\nExclusion Criteria:\n\n* Genetic conditions associated with overweight.\n* Endocrine conditions associated with overweight.\n* Chronic steroid therapy.\n* Current enrollment in a professional weight management program.'}, 'identificationModule': {'nctId': 'NCT00993434', 'briefTitle': 'The Impact of Educational Materials on Family Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Impact of Educational Materials on Family Behavior', 'orgStudyIdInfo': {'id': 'M-2009-1162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kid STRIDE Booklet', 'interventionNames': ['Behavioral: Booklet on nutrition and physical activity.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Safety Booklet', 'interventionNames': ['Behavioral: Safety Booklet']}], 'interventions': [{'name': 'Booklet on nutrition and physical activity.', 'type': 'BEHAVIORAL', 'description': 'Parents will be asked to read the booklet and complete a pre- and post-questionnaire.', 'armGroupLabels': ['Kid STRIDE Booklet']}, {'name': 'Safety Booklet', 'type': 'BEHAVIORAL', 'description': 'Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.', 'armGroupLabels': ['Safety Booklet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53703', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'GHC Capitol Pediatric Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health East Towne Pediatrics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53717', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health West Towne Pediatrics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health Park Street Pediatrics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ellen R Wald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Madison Dept of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}