A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
Primary Purpose
Child Obesity, Child Development
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beverage Intervention
Reading Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Child Obesity
Eligibility Criteria
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
Sites / Locations
- San Francisco General Hospital Children's Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Beverage Intervention
Reading Intervention
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04754269
First Posted
February 10, 2021
Last Updated
November 15, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04754269
Brief Title
A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
Official Title
Randomized Controlled Trial of an M-health Intervention to Reduce Sweet Beverage Consumption Among Low-income Latino Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Obesity, Child Development
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beverage Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Reading Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Beverage Intervention
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Reading Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Change in 7-day child consumption of sugar-sweetened beverages and 100% fruit juice
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
Time Frame
Change from baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in 7 day total parent intake of sugar-sweetened beverages
Description
Parents will report their own consumption of sugar-sweetened beverages in the previous 7 days in 8 ounce servings via a verbal questionnaire
Time Frame
Change from baseline to 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Beck, MD, MPH
Phone
(415) 476-3368
Email
amy.beck@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Beck, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital Children's Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy L Beck, MD MPH
Phone
415-476-3368
Email
amy.beck@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
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