NCT04754269

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

February 10, 2021

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in 7 day total parent intake of sugar-sweetened beverages

    Change from baseline to 3-month follow-up

Study Arms (2)

Beverage Intervention

EXPERIMENTAL

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.

Behavioral: Beverage Intervention

Reading Intervention

EXPERIMENTAL

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.

Behavioral: Reading Intervention

Interventions

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.

Beverage 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.

Reading Intervention

Eligibility Criteria

Age12 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Child does not feed by mouth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital Children's Health Center

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy L Beck, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

March 5, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations