Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT02257203
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2014-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Beverage Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003731', 'term': 'Dental Caries'}], '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'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2014-09-24', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)", 'timeFrame': 'Baseline', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)", 'timeFrame': '2 weeks', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)", 'timeFrame': '2 months', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)", 'timeFrame': '3 months', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines", 'timeFrame': 'Baseline', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines", 'timeFrame': '2 weeks', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines", 'timeFrame': '2 months', 'description': '24-hour recall'}, {'measure': "Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines", 'timeFrame': '3 months', 'description': '24-hour recall'}], 'secondaryOutcomes': [{'measure': 'Servings of SSB and 100% fruit juice in the past 7 days', 'timeFrame': 'Baseline', 'description': 'From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point'}, {'measure': 'Servings of SSB and 100% fruit juice in the past 7 days', 'timeFrame': '2 weeks', 'description': 'From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point'}, {'measure': 'Servings of SSB and 100% fruit juice in the past 7 days', 'timeFrame': '2 months', 'description': 'From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point'}, {'measure': 'Servings of SSB and 100% fruit juice in the past 7 days', 'timeFrame': '3 months', 'description': 'From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dietary sucrose'], 'conditions': ['Obesity', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized clinical trial of a brief educational intervention offered in primary care for Latino parents that promotes healthy beverage consumption by infants and toddlers. The control group will receive an educational intervention that promotes parents reading to children.', 'detailedDescription': 'To use a randomized controlled trial (RCT) design to test the efficacy of a primary care-based intervention to promote Bright Futures recommendations for consumption of sugar-sweetened beverages and 100% fruit juice among Latino children ages 6 months to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents self-identify as Latino\n* Parents speak English or Spanish\n* Parents have a child between the ages of 6 months and 5 years\n\nExclusion Criteria:\n\n* Parents who have participated in group educational sessions on nutrition offered through our obesity clinic or who have been newly referred to obesity clinic\n* Parents whose child has a chronic condition which affects feeding (such as requiring tube feeds or being on a specialized diet for poor weight gain)'}, 'identificationModule': {'nctId': 'NCT02257203', 'briefTitle': 'Primary Care Beverage Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children', 'orgStudyIdInfo': {'id': 'PC-Based Beverage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugar Sweetened Beverage Education', 'description': "Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic", 'interventionNames': ['Behavioral: Sugar Sweetened Beverage Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reading Education', 'description': "Parents will receive an educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age", 'interventionNames': ['Behavioral: Reading Education']}], 'interventions': [{'name': 'Sugar Sweetened Beverage Education', 'type': 'BEHAVIORAL', 'description': "Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic", 'armGroupLabels': ['Sugar Sweetened Beverage Education']}, {'name': 'Reading Education', 'type': 'BEHAVIORAL', 'description': "Parents randomized to control will receive a 25-minute educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age", 'armGroupLabels': ['Reading Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "Children's Health Center at San Francisco General Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Amy L Beck, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academic Pediatric Association', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}