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

NCT05112185 | Active Not Recruiting DMC

• 2 other identifiers: 616061R01DK127124-01A1
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

water; sugar-sweetened beverages; childcare

Outcome Measures

Primary Outcomes (1)

• Change in BMI z-score

  The BMI measure will be calculated using height and weight measurements.

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

Secondary Outcomes (3)

• Total 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

  Baseline and 12-months after the start of the study.

• Beverage intake frequency

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

Study Arms (2)

Healthy Beverage Access and Promotion

EXPERIMENTAL

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.

Behavioral: Healthy Drinks, Healthy Futures

Control

NO INTERVENTION

Usual care.

Interventions

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.

Healthy Beverage Access and Promotion

Eligibility Criteria

• Age: 2 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preschool-age children and families who don't have health conditions that preclude intake of water

You may not qualify if:

• Children not of preschool-age
• Children and families who do not speak English or Spanish

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Francisco: collaborator
• University of California Agriculture and Natural Resources: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford

Stanford, California, 94305-5119, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anisha Patel, MD, MSPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)