Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT04754269
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 7-day child consumption of sugar-sweetened beverages and 100% fruit juice', 'timeFrame': 'Change from baseline to 3-month follow-up', 'description': 'Parents will report child consumption of sugar-sweetened beverages and 100% fruit juice over previous 7 days in fluid ounces via a verbal questionnaire. The outcome measure will be the summed 7-day total of sugar-sweetened beverages and 100% fruit juice in fluid ounces'}], 'secondaryOutcomes': [{'measure': 'Change in 7 day total parent intake of sugar-sweetened beverages', 'timeFrame': 'Change from baseline to 3-month follow-up', 'description': 'Parents will report their own consumption of sugar-sweetened beverages in the previous 7 days in 8 ounce servings via a verbal questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Obesity', 'Child Development']}, 'descriptionModule': {'briefSummary': "Sugar-sweetened beverage consumption is a major contributor to childhood obesity, caries, fatty liver disease, and Type 2 diabetes. Latino children are more likely to consume sugar-sweetened beverages (SSBs) and to suffer from all of the aforementioned conditions. Reading out loud to children from birth through age 5 is critical for the promotion of language and early literacy skills. Children whose parents read aloud to them are more likely to start school with the skills required for early reading success. This is important as reading proficiency in third grade is the best predictor of high school graduation and career success. Latino children are less likely to be read to than non-Hispanic white children and at higher risk of entering kindergarten without critical early literacy skills. Thus, there is a pressing need for interventions to reduce SSB consumption among Latino children as well as interventions that promote reading out loud. Primary care is an optimal setting for such interventions. However, multiple demands on providers' time make it difficult to rely on in-person interventions. For this reason, it is critical to test intervention designs that do not rely directly on health care providers and that can be delivered remotely if needed. The investigators have developed two m-health interventions for Latino parents, one that promotes optimal beverage consumption patterns and one that promotes reading out loud to children. The purpose of this study is to test the impact of these interventions on child beverage intake patterns and the frequency with which parents read to children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent identifies child as Latino/a/x\n* Child age 1 to 5 (12 to 59 months)\n* Parent has a cell phone that can receive text messages\n* Parent speak English or Spanish\n\nExclusion Criteria:\n\n• Child does not feed by mouth'}, 'identificationModule': {'nctId': 'NCT04754269', 'briefTitle': 'A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Randomized Controlled Trial of an M-health Intervention to Reduce Sweet Beverage Consumption Among Low-income Latino Children', 'orgStudyIdInfo': {'id': '20-30664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beverage Intervention', 'description': 'Parents will watch a video that promotes optimal beverage practices for young children. Parents will receive that reinforce and expand on the messages in the video.', 'interventionNames': ['Behavioral: Beverage Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Reading Intervention', 'description': 'Parents will watch a video that promotes reading to children. Parents will receive text messages that reinforce and expand on the messages in the video.', 'interventionNames': ['Behavioral: Reading Intervention']}], 'interventions': [{'name': 'Beverage Intervention', 'type': 'BEHAVIORAL', 'description': 'Parents will watch a video that promotes optimal beverage practices for young children including discouraging consumption of sugar-sweetened beverages and fruit juice and encouraging consumption of water and unsweetened milk. Parents will receive 24 text messages over a 12 week period that reinforce and expand on the messages in the video.', 'armGroupLabels': ['Beverage Intervention']}, {'name': 'Reading Intervention', 'type': 'BEHAVIORAL', 'description': 'Parents will watch a video that promotes reading to children and includes specific ideas and techniques for how to make reading interactive and engaging. Parents will receive 24 text messages over a 12 week period that reinforce and expand on the messages in the video.', 'armGroupLabels': ['Reading Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy L Beck, MD MPH', 'role': 'CONTACT', 'email': 'amy.beck@ucsf.edu', 'phone': '415-476-3368'}], 'facility': "San Francisco General Hospital Children's Health Center", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Amy Beck, MD, MPH', 'role': 'CONTACT', 'email': 'amy.beck@ucsf.edu', 'phone': '(415) 476-3368'}], 'overallOfficials': [{'name': 'Amy L Beck, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}