- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754269
A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
November 15, 2021 updated by: University of California, San Francisco
Randomized Controlled Trial of an M-health Intervention to Reduce Sweet Beverage Consumption Among Low-income Latino Children
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy Beck, MD, MPH
- Phone Number: (415) 476-3368
- Email: amy.beck@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Recruiting
- San Francisco General Hospital Children's Health Center
-
Contact:
- Amy L Beck, MD MPH
- Phone Number: 415-476-3368
- Email: amy.beck@ucsf.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beverage Intervention
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 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.
|
Experimental: Reading Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 7-day child consumption of sugar-sweetened beverages and 100% fruit juice
Time Frame: Change from baseline to 3-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 7 day total parent intake of sugar-sweetened beverages
Time Frame: Change from baseline to 3-month follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amy L Beck, MD, MPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2021
Primary Completion (Anticipated)
December 15, 2022
Study Completion (Anticipated)
December 15, 2022
Study Registration Dates
First Submitted
February 10, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 15, 2021
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-30664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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