Healthy Beverage Access for Childhood Obesity

Overseen By Anisha Patel, MD, MSPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-preschool age, Non-English/Spanish speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if promoting healthier drink choices in childcare centers can prevent obesity in young children by encouraging more water consumption instead of sugary drinks. The study will test whether providing self-serve water pitchers and educational materials to families influences children's beverage habits and overall health. Families with preschool-age children who can drink water without health issues might be a good fit for this study. As an unphased trial, this study offers families the chance to contribute to important research that could enhance children's health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for children?

Research shows that encouraging kids to drink water instead of sugary drinks can help prevent childhood obesity. The Healthy Drinks, Healthy Futures program supports this goal. While specific safety data for this program is unavailable, increasing water intake is generally safe for children. Water is a natural and essential part of any diet. The program uses BPA-free pitchers and cups, ensuring safe water service. Since the focus is on water and healthy drinks, this approach carries no known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Beverage Access for Childhood Obesity trial because it introduces innovative strategies to promote healthy drinking habits among kids. Unlike traditional approaches that might focus on diet and exercise alone, this trial emphasizes providing BPA-free self-serve pitchers and cups, making water a more accessible and appealing choice during meals. Additionally, customized education helps families set and achieve their own healthy drink goals, which could empower lasting change in beverage consumption habits. This approach is unique because it combines practical tools with personal education, potentially leading to more sustainable lifestyle changes compared to standard care.

What evidence suggests that the Healthy Drinks, Healthy Futures Program could be effective for preventing childhood obesity?

Research has shown that encouraging kids to drink water instead of sugary drinks can help prevent obesity in schoolchildren. Choosing water over sugary drinks significantly contributes to keeping kids healthy. The Healthy Drinks, Healthy Futures program is being tested in this trial to support this change by providing tools and education to childcare centers and families. Participants in the "Healthy Beverage Access and Promotion" arm will receive BPA-free self-serve pitchers and cups for serving water at mealtimes, individualized education to help families set healthy drink goals, and a curriculum focused on increasing intake of water and healthy beverages. Although still being tested with younger children, starting these healthy habits early could prove even more effective. This approach aims to create a healthier environment for kids, potentially reducing obesity rates from a young age. ^{1 2 3 4 6}

Who Is on the Research Team?

Anisha Patel, MD, MSPH

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for preschool-age children and their families who can drink water without health issues. It's not for those outside of preschool age or families who don't speak English, Spanish, or Vietnamese.

Inclusion Criteria

My child is preschool-aged and can safely drink water.

Exclusion Criteria

My child is school-aged or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the Healthy Drinks, Healthy Futures intervention, including BPA-free self-serve pitchers and cups, individualized education, and curricula focused on increasing water and healthy beverage intake

6 months

Regular visits to childcare centers for intervention activities

Follow-up

Participants are monitored for changes in BMI z-score and beverage intake at home and childcare centers

6 months

Assessments at 6 months and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Drinks, Healthy Futures

Trial Overview

The study tests a childcare-based program called 'Healthy Drinks, Healthy Futures' that encourages drinking water instead of sugary drinks to see if it helps prevent obesity in young kids.

How Is the Trial Designed?

Group I: Healthy Beverage Access and Promotion Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Usual care.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of California Agriculture and Natural Resources

Collaborator

Trials

1

Recruited

880+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of California

Collaborator

Trials

46

Recruited

208,000+

Published Research Related to This Trial

A study involving 15 out of 18 schools showed that by changing beverage sales practices to include more healthful options at discounted prices, schools could increase profits while promoting better beverage choices among children.

The introduction of healthier beverages led to a decline in carbonated soft drink sales, demonstrating that strategic marketing and pricing can effectively encourage children to choose more nutritious drinks during the school day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing sales of beverages in schools to preserve profits and improve children's nutrition intake in 15 Mississippi schools. Brown, DM., Tammineni, SK.[2018]

A workshop aimed at youths aged 5-14 successfully increased their knowledge about the sugar content in sugar-sweetened beverages (SSBs), with over 80% of participants regularly consuming these drinks.

While the workshop did not significantly change attitudes towards SSBs, most participants expressed enjoyment of the program and a desire to reduce their intake, highlighting the need for longer-term interventions that also involve parents to effectively change beverage choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blending better beverage options: a nutrition education and experiential workshop for youths. Isoldi, KK., Dolar, V.[2018]

The 12-week intervention promoting healthier beverage choices in childcare centers led to a significant reduction of 5.9 ounces per day in less-healthy beverage consumption among children, while increasing healthier beverage intake by 3.5 ounces per day.

Children in the intervention group experienced a 3 percentage point decrease in the likelihood of being overweight, contrasting with a 3 percentage point increase in the control group, suggesting that comprehensive interventions can positively impact children's weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multipronged beverage intervention on young children's beverage intake and weight: a cluster-randomized pilot study. Grummon, AH., Cabana, MD., Hecht, AA., et al.[2023]

Consumption of non-nutritive sweetened beverages (NNSBs) is linked to an increased risk of overweight and obesity in children, especially among those with a high BMI polygenic risk score, with a notable increase in risk observed by ages 14-15.

In contrast, sugar-sweetened beverage (SSB) consumption showed limited association with subsequent overweight or obesity, suggesting that interventions targeting NNSB consumption may be particularly important for children at higher genetic risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polygenic Risk Scores and the Risk of Childhood Overweight/Obesity in Association With the Consumption of Sweetened Beverages: A Population-Based Cohort Study. Sycamnias, L., Kerr, JA., Lange, K., et al.[2023]

In a study of 371 children, the primary source of feeding information for mothers significantly influenced their children's juice intake, with those receiving advice from doctors showing a 19.7% annual decrease in juice consumption, while those influenced by grandmothers showed only a 5.0% decrease.

Overall, children's intake of sugar-sweetened beverages (SSBs) increased by 7.1% each year, regardless of the information source, and children whose primary source was their grandmother had the highest levels of adiposity over time, suggesting the need for consistent, evidence-based dietary guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of mothers' source of feeding information with longitudinal trajectories of sugar-sweetened beverage intake, 100% juice intake and adiposity in early childhood. Korn, AR., Economos, CD., Hammond, RA., et al.[2021]

The 'Shape Your Future - Rethink Your Drink' program led to an 18.6% reduction in sugar-sweetened beverage (SSB) consumption among Oklahoma adults with children, indicating its effectiveness in promoting healthier drinking habits.

Heavy SSB consumption decreased by 42.9%, and various factors such as education level, health status, and access to healthy foods were associated with SSB consumption, highlighting the need for targeted messaging in future health campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with sugar-sweetened beverage consumption in adults with children in the home after a statewide health communications program. James, SA., White, AH., Paulson, SW., et al.[2022]

A study of 22,291 children aged 6 months to 17 years found that higher consumption of sugary drinks is linked to increased body mass index (BMIz), particularly in school-aged children (6-17 years), where those consuming three or more sugary drinks per day had a significantly higher BMIz compared to those consuming less than one per week.

The research suggests that early childhood (ages 2-5) is a critical time for addressing sugary beverage consumption, as even at high consumption levels, it was associated with a notable increase in BMIz, indicating a potential target for obesity prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Electronic Health Record Data to Study the Association of Sugary Drink Consumption With Child Weight Status. Lewis, KH., Skelton, J., Hsu, FC., et al.[2021]

Child care programs in Georgia that participate in the Child and Adult Care Food Program (CACFP) are significantly less likely to serve sugar-sweetened beverages (SSBs) compared to non-CACFP programs, indicating a positive impact of CACFP on beverage choices.

CACFP programs also have a higher likelihood of serving low-fat or fat-free milk to young children, which supports healthier dietary habits, although overall compliance with water policies remains low across all program types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beverage Policy Implementation by Child and Adult Care Food Program Participation and Program Type: A Statewide Examination in Georgia. Cotwright, CJ., Bradley, H., Celestin, N., et al.[2020]

In a study of 366 Danish children aged 2-6 years, higher consumption of sugary drinks was linked to significant increases in body weight and BMI, highlighting the risk of obesity in young children predisposed to weight gain.

Replacing sugary drinks with milk was associated with a decrease in both body weight and BMI, suggesting that milk can be a beneficial alternative for managing weight in children at risk of obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing sugary drinks with milk is inversely associated with weight gain among young obesity-predisposed children. Zheng, M., Rangan, A., Allman-Farinelli, M., et al.[2015]

The intervention promoting fruit-infused water (FIW) among preschoolers' parents was found to be feasible and acceptable, with parents reporting positive themes such as it being a healthy alternative and easy to prepare at home.

Preliminary results from ten parents indicated a reduction in their preschoolers' sugar-sweetened beverage intake and an increase in parents' confidence and knowledge about making and consuming FIW.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of parents promoting fruit-infused water to reduce preschool children's sugar-sweetened beverage consumption. Quelly, SB., Eckhoff, DO., Luzincourt, G., et al.[2022]

The Coca-Cola Company is actively promoting healthier lifestyles by offering a variety of innovative beverages, including options with fewer calories and enhanced nutritional benefits, while also implementing responsible advertising practices, especially towards children.

The establishment of The Beverage Institute for Health & Wellness, which includes experts in nutrition and health, aims to support scientific research and consumer education on the importance of beverages in maintaining a healthy lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When science met the consumer: the role of industry. Short, D.[2023]

The Healthy Beverage Index for Children and Adolescents (HBI-CA) was developed to assess beverage intake quality in youth, based on data from 2,874 participants aged 2 to 19 years, and showed a mean total score of 69.2, indicating a solid foundation for evaluating beverage choices.

The HBI-CA demonstrated good validity and reliability, with strong correlations between its components and total scores, suggesting it could effectively help in quantifying and improving beverage intake quality among children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Assessment of the Healthy Beverage Index for US Children and Adolescents: A Tool to Quantify the Overall Beverage Intake Quality of 2- to 19-Year Olds. Parker, MK., Davy, BM., Hedrick, VE.[2022]

Recent trends show that children and adolescents are consuming fewer calories from beverages, but sugar-sweetened beverages (SSBs) still account for the majority of added sugars in their diets, highlighting the need to reduce SSB intake for better dietary quality.

This review provides a comprehensive table of beverage recommendations for ages 0-19, identifying gaps in existing guidelines and offering actionable strategies for public health professionals to improve beverage consumption patterns among youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Knowledge Base of Beverage Health Impacts, Trends, and Intake Recommendations for Children and Adolescents: Implications for Public Health. Parker, MK., Davy, BM., Hedrick, VE.[2022]

The Healthy Communities Study (HCS) involves a comprehensive examination of community programs and policies across 130 communities to understand their impact on childhood obesity, diet, and physical activity, with data collected from multiple levels including community, school, household, and child.

The study emphasizes rigorous training and quality control measures for data collection, ensuring reliable results, and highlights the importance of collaboration among various teams to manage the complexity of the research effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operational Implementation of the Healthy Communities Study: How Communities Shape Children's Health. John, LV., Gregoriou, M., Pate, RR., et al.[2018]

Citations

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clinicaltrials.gov/study/NCT05112185

NCT05112185 | Childcare Healthy Beverage Access, Food ...

The proposed cluster-randomized controlled trial will test the efficacy of an intervention called Healthy Drinks, Healthy Futures (Bebidas Saludables, Futuros ...

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reporter.nih.gov/search/gt6igMXp8kSJ3x2zq-NcSQ/project-details/10901914

patel, anisha indravadan - NIH RePORTER

The Specific Aims are to: 1) Estimate the short-term cost, population reach and effectiveness of Water First and Heathy Drinks, Healthy Futures interventions in ...

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Healthy Drinks, Healthy Futures

The goal of the Healthy Drinks, Healthy Futures randomized controlled study is to understand if promoting intake of healthy beverages in childcare centers and ...

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withpower.com

withpower.com/trial/healthy-beverage-access-for-childhood-obesity-39ca5

Healthy Beverage Access for Childhood Obesity

Interventions that promote water consumption in place of sugar-sweetened beverages have shown promise for preventing childhood obesity in schoolchildren.

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clinicaltrials.ucsf.edu

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UCSF Obesity Trial → Childcare Healthy Beverage Access, ...

Interventions that promote water consumption in place of sugar-sweetened beverages have shown promise for preventing childhood obesity in schoolchildren.

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stanfordhealthcare.org/trials/c/NCT05112185.html

Childcare Healthy Beverage Access, Food and ...

Interventions that promote water consumption in place of sugar-sweetened beverages have shown promise for preventing childhood obesity in schoolchildren. Yet to ...