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Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112185
Enrollment
1034
Registered
2021-11-08
Start date
2022-10-19
Completion date
2025-09-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

water, sugar-sweetened beverages, childcare

Brief summary

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.

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.

Interventions

BEHAVIORALHealthy Drinks, Healthy Futures

The Healthy Drinks, Healthy Futures intervention consists of increased access to and promotion of 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.

Sponsors

Stanford University
Lead SponsorOTHER
University of California, San Francisco
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of California, Davis
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 105 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in BMI Z-scoreBaseline, 6-months, and 10-months after the start of the study.Trained research staff measure children's heights and weights as outlined in the National Health and Nutrition Examination Survey Anthropometry Procedures Manual. BMI z-scores (or standard deviation scores) are used to quantify how far a child's anthropometry measurement deviates from the median of a reference population. The score is calculated using the sex, age, weight, and height of the participant, and is based on growth references for children. A z-score of 0 reflects the 50th percentile (the median) of the reference growth charts. For example, a z-score of 1.5 indicates a child is 1.5 standard deviation units above the reference median, whereas a z-score of -1.5 means a child is 1.5 below it, adjusting for childhood BMI distributions.

Secondary

MeasureTime frameDescription
Total Caloric Intake From Beverages at Childcare CentersBaseline and 10-months after the start of the study.Trained research staff conduct two day-long plate waste measurements per center. Beverages are weighed before and after intake.
Total Caloric Intake From Beverages Outside of Childcare CentersBaseline and 10-months after the start of the study.Calorie content of beverages consumed outside of childcare centers derived from ASA24® nutrient database.
Total Water Intake From Beverages at Childcare CentersBaseline, and 10-months after the start of the study.Trained research staff conduct two day-long plate waste measurements, per center. Water is weighed before and after intake.
Total Water Intake Outside of Childcare CentersBaseline, and 10-months after the start of the study.Water intake outside of childcare centers derived from ASA24® nutrient database.
Beverage IntakeBaseline, 6-months, and 10-months after the start of the study.Beverage intake frequency questionnaire (BEVQ PS) used to calculate past-week frequency of beverages consumed (ounces/day).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnisha Patel, MD, MSPH

Stanford University

Participant flow

Recruitment details

This study enrolled preschool-aged children in participating licensed childcare centers serving predominantly low-income families, their parents or legal guardians, and childcare providers working in participating childcare centers who implemented study activities and center-level practices.

Baseline characteristics

Characteristic
Age, Continuous31.92 Years
STANDARD_DEVIATION 6.38
Beverage kcal at childcare48.88 kcal
Beverage kcal at home100.67 kcal
BMI Z-score0.71 z-score
STANDARD_DEVIATION 1.07
Ethnicity (NIH/OMB)
Hispanic or Latino
184 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
25 Participants
Race (NIH/OMB)
American Indian or Alaska Native
8 Participants
Race (NIH/OMB)
Asian
115 Participants
Race (NIH/OMB)
Black or African American
8 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
386 Participants
Race (NIH/OMB)
White
105 Participants
Region of Enrollment
United States
24 participants
Sex: Female, Male
Female
203 Participants
Sex: Female, Male
Male
17 Participants
SSB ounces at home (BEVQ-PS)2.10 Ounces
Water ounces at childcare4.25 Ounces
Water ounces at home (ASA24)8.47 Ounces
Water ounces at home (BEVQ-PS)14.68 Ounces

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 2460 / 2480 / 240 / 2441 / 2450 / 27
other
Total, other adverse events
0 / 2460 / 2480 / 240 / 2440 / 2450 / 27
serious
Total, serious adverse events
0 / 2460 / 2480 / 240 / 2441 / 2450 / 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026