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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04754269
Other study ID # 20-30664
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 5, 2021
Est. completion date July 1, 2025

Study information

Verified date April 2024
Source University of California, San Francisco
Contact Amy Beck, MD, MPH
Phone (415) 476-3368
Email amy.beck@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Months to 59 Months
Eligibility Inclusion Criteria: - Parent identifies child as Latino/a/x - Child age 1 to 5 (12 to 59 months) - Parent has a cell phone that can receive text messages - Parent speak English or Spanish Exclusion Criteria: • Child does not feed by mouth

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Beverage Intervention
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.
Reading Intervention
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.

Locations

Country Name City State
United States San Francisco General Hospital Children's Health Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 7-day child consumption of sugar-sweetened beverages and 100% fruit juice 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 Change from baseline to 3-month follow-up
Secondary Change in 7 day total parent intake of sugar-sweetened beverages Parents will report their own consumption of sugar-sweetened beverages in the previous 7 days in 8 ounce servings via a verbal questionnaire Change from baseline to 3-month follow-up
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