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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A cluster randomized controlled trial of a multi-level intervention to promote healthy beverage intake through
Kiara Revels1, Lorrene D Ritchie2, Laura Schmidt3
1Stanford University School of Medicine, 3145 Porter Drive, Office F110, Palo Alto, CA 94304, United States of America.
Introduction:
Promotion of safe and accessible drinking water in schools shows promise for increasing water intake, reducing sugar-sweetened beverage (SSB) intake, and preventing overweight and obesity. No large-scale studies have evaluated how a water promotion and SSB reduction intervention in childcare centers affects children's weight status. The Healthy Drinks, Healthy Futures study will assess this strategy.
Methods:
Following the Social-Ecological Model and Social Cognitive Theory, the Healthy Drinks, Healthy Futures intervention supports changes in childcare and home environments that promote water access while reducing SSB availability. These environmental changes are combined with education for childcare providers and children and brief motivational counseling with parents to reduce SSB consumption and encourage water consumption. Fourteen childcare centers in Santa Clara County, California serving low-income, predominately Latino children ages 2-5 years will participate in this cluster randomized controlled trial. The primary outcome is child BMI Z-score captured at baseline, ~ 6-months and ~ 10 months using anthropometric measures. Dietary outcomes, measured at baseline and ~ 10 months, include intake of water and beverage calories while in childcare (plate waste) and in environments outside of childcare (Automated Self-Administered 24-h dietary recalls). Questionnaires at baseline, ~ 6- and ~ 10-months examine effects on frequency of intake of different beverages.
Discussion:
This manuscript details the rationale, intervention design, and implementation of the Healthy Drinks, Healthy Futures study. If successful, study results will contribute valuable insights into strategies to promote healthy beverage intake and prevent obesity among young children in childcare centers.
Clinicaltrials:
gov registration number: NCT05112185.