Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Drinks, Healthy Futures
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring water, sugar-sweetened beverages, childcare
Eligibility Criteria
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 or Vietnamese
Sites / Locations
- StanfordRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Healthy Beverage Access and Promotion
Control
Arm Description
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.
Usual care.
Outcomes
Primary Outcome Measures
Change in BMI z-score
The BMI measure will be calculated using height and weight measurements.
Secondary Outcome Measures
Total caloric intake from beverages at childcare centers
Plate waste measurements will be used to calculate total daily caloric intake from beverages at childcare centers.
Total beverage caloric intake from beverages at home
Automated Self-Administered 24-Hour (ASA24) will be used to calculate total daily caloric intake from beverages at home.
Beverage intake frequency
BevQ 19 and BevQ PS
Full Information
NCT ID
NCT05112185
First Posted
October 27, 2021
Last Updated
April 27, 2023
Sponsor
Stanford University
Collaborators
University of California, San Francisco, University of California Agriculture and Natural Resources, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05112185
Brief Title
Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity
Official Title
Healthy Drinks, Healthy Futures: The Impact of a Childcare-based Healthy Beverages Intervention on Young Children's Food and Beverage Intake and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, San Francisco, University of California Agriculture and Natural Resources, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
water, sugar-sweetened beverages, childcare
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
882 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Beverage Access and Promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Drinks, Healthy Futures
Intervention Description
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 Outcome Measure Information:
Title
Change in BMI z-score
Description
The BMI measure will be calculated using height and weight measurements.
Time Frame
Baseline, 6-months, and 12-months after the start of the study.
Secondary Outcome Measure Information:
Title
Total caloric intake from beverages at childcare centers
Description
Plate waste measurements will be used to calculate total daily caloric intake from beverages at childcare centers.
Time Frame
Baseline and 12-months after the start of the study.
Title
Total beverage caloric intake from beverages at home
Description
Automated Self-Administered 24-Hour (ASA24) will be used to calculate total daily caloric intake from beverages at home.
Time Frame
Baseline and 12-months after the start of the study.
Title
Beverage intake frequency
Description
BevQ 19 and BevQ PS
Time Frame
Baseline, 6-months, and 12-months after the start of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anisha Patel, MD, MSPH
Phone
650-497-1181
Email
anipatel@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisha Patel, MD, MSPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anisha Patel, MD, MSPH
Phone
650-497-1181
Email
anipatel@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity
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