- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05112185
Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity
September 15, 2025 updated by: Anisha I Patel, Stanford University
Healthy Drinks, Healthy Futures: The Impact of a Childcare-based Healthy Beverages Intervention on Young Children's Food and Beverage Intake and Obesity
Interventions that promote water consumption in place of sugar-sweetened beverages have shown promise for preventing childhood obesity in schoolchildren.
Yet to date, no studies have examined whether applying this approach in childcare centers could help to prevent childhood obesity at an even earlier stage of development.
This cluster-randomized controlled trial will fill gaps by examining how a multilevel childcare-based healthy beverage intervention affects young children's consumption of beverages and obesity.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
There is little debate that sugar-sweetened beverages (SSBs; drinks with added sugar) lack nutrition, are a major source of added sugar and calories, and promote obesity and poor cardiometabolic health, especially when consumed during early childhood.
Nearly half of children aged 2-5 drink SSBs on a daily basis, with heavier consumption in low-income Latino children.
After decades of research, it is clear that there is no single "magic bullet" for solving obesity.
What we need are bundled interventions that combine incremental changes that transform food environments with targeted behavior changes that steer people towards those healthy options.
Childcare centers, which serve 12.5 million children per year, provide an efficient way to intervene early by engaging childcare providers and parents to make resonant, mutually reinforcing changes in both the home and childcare environment.
Interventions that promote water consumption in place of SSBs have shown promise for preventing childhood obesity in schoolchildren.
Yet, no studies have examined whether interventions to promote intake of water instead of SSBs in childcare could prevent childhood obesity at an even earlier stage of development.
The proposed cluster-randomized controlled trial will test the efficacy of an intervention called Healthy Drinks, Healthy Futures (Bebidas Saludables, Futuros Saludables) that is culturally adapted for Latino children and families.
Following the Social-Ecological Model and Social Learning Theory, the intervention supports complementary changes in the childcare and home food environments that promote water consumption while reducing SSB availability.
This is combined with education for childcare providers and children, and a one-on-one brief motivational counseling intervention with parents to reduce SSB intake and encourage water consumption in the home.
Fourteen childcare centers serving low-income, predominately Latino children (n=420) will participate in this trial.
The primary outcome is child BMI z-score (BMI standard deviation score).
Key secondary outcomes are intake of water and beverage calories at centers and at home.
Outcomes will be captured using anthropometrics (weight, height), and beverage frequency questionnaires at baseline, 6-months, and 12-months post-intervention.
Plate waste measurements (water and caloric intake at centers) and Automated Self-Administered 24-hour dietary recalls (water and caloric intake at home) will occur at baseline and 12 months post-intervention.
Surveys of childcare providers and parents will allow us to explore possible mediators of the intervention effect.
We hypothesize that the childcare-based healthy beverage intervention will increase intake of water and reduce beverage calories consumed at both childcare and at home.
BMI z-score will also improve among children in intervention centers vs. control centers.
If shown to be effective, the Healthy Drinks, Healthy Futures intervention will offer a strategy for intervening early to prevent obesity for millions of low-income children attending childcare centers.
Findings from this study will contribute to the science of multilevel obesity prevention, and inform the implementation of state, federal, and local policies to promote healthy beverage intake in childcare centers.
Study Type
Interventional
Enrollment (Estimated)
882
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 Locations
-
-
California
-
Stanford, California, United States, 94305-5119
- Stanford
-
-
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 101 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Preschool-age children and families who don't have health conditions that preclude intake of water
Exclusion Criteria:
- Children not of preschool-age
- Children and families who do not speak English or Spanish
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Usual care.
|
|
|
Experimental: Healthy Beverage Access and Promotion
Intervention group will receive BPA-free self-serve pitchers and cups for serving water at mealtimes, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages.
|
The Healthy Drinks, Healthy Futures intervention consists of increased access to healthy beverages in childcare centers and education directed to children and their families to increase the intake of healthy beverages, including motivational beverage counseling for families and lessons for children in childcare centers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BMI z-score
Time Frame: Baseline, 6-months, and 12-months after the start of the study.
|
The BMI measure will be calculated using height and weight measurements.
|
Baseline, 6-months, and 12-months after the start of the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total caloric intake from beverages at childcare centers
Time Frame: Baseline and 12-months after the start of the study.
|
Plate waste measurements will be used to calculate total daily caloric intake from beverages at childcare centers.
|
Baseline and 12-months after the start of the study.
|
|
Total beverage caloric intake from beverages at home
Time Frame: Baseline and 12-months after the start of the study.
|
Automated Self-Administered 24-Hour (ASA24) will be used to calculate total daily caloric intake from beverages at home.
|
Baseline and 12-months after the start of the study.
|
|
Beverage intake frequency
Time Frame: Baseline, 6-months, and 12-months after the start of the study.
|
BevQ 19 and BevQ PS
|
Baseline, 6-months, and 12-months after the start of the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anisha Patel, MD, MSPH, Stanford University
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)
October 19, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
October 27, 2021
First Submitted That Met QC Criteria
October 27, 2021
First Posted (Actual)
November 8, 2021
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 15, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61606
- 1R01DK127124-01A1 (U.S. NIH Grant/Contract)
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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