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Completed

NCT Number: NCT05112185

Childcare Healthy Beverage Access, 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.

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Key information

Age range

2 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Stanford, California, 94305-5119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Drinks, Healthy Futures

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Beverage intake frequency

    Time frame: Baseline, 6-months, and 12-months after the start of the study.

    BevQ 19 and BevQ PS

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of California, Davis
  • University of California, San Francisco

Registry information

Official study title

Healthy Drinks, Healthy Futures: The Impact of a Childcare-based Healthy Beverages Intervention on Young Children's Food and Beverage Intake and Obesity

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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