ObesityNCT05112185
Childcare Healthy Beverage Access, Food and Beverage Intake, and Obesity
A study testing Healthy Drinks, Healthy Futures in people with Obesity, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 105 years
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Drinks, Healthy Futures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,034 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preschool-age children and families who don't have health conditions that preclude intake of water
Who cannot join
- Children not of preschool-age
- Children and families who do not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Healthy Drinks, Healthy Futures
- Keywords
- water, sugar-sweetened beverages, childcare
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Drinks, Healthy FuturesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Beverage Access and Promotion | Experimental | Intervention group will receive pitchers, water bottles, and cups for serving water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages. Receives: Behavioral: Healthy Drinks, Healthy Futures |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI Z-score
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.
Measured: Baseline, 6-months, and 10-months after the start of the study.
Secondary outcomes (5)
Total Caloric Intake From Beverages at Childcare Centers
Trained research staff conduct two day-long plate waste measurements per center. Beverages are weighed before and after intake.
Measured: Baseline and 10-months after the start of the study.
Total Caloric Intake From Beverages Outside of Childcare Centers
Calorie content of beverages consumed outside of childcare centers derived from ASA24® nutrient database.
Measured: Baseline and 10-months after the start of the study.
Total Water Intake From Beverages at Childcare Centers
Trained research staff conduct two day-long plate waste measurements, per center. Water is weighed before and after intake.
Measured: Baseline, and 10-months after the start of the study.
Total Water Intake Outside of Childcare Centers
Water intake outside of childcare centers derived from ASA24® nutrient database.
Measured: Baseline, and 10-months after the start of the study.
Beverage Intake
Beverage intake frequency questionnaire (BEVQ PS) used to calculate past-week frequency of beverages consumed (ounces/day).
Measured: Baseline, 6-months, and 10-months after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start19 Oct 2022
- Primary completion12 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Davis
- Responsible party
- Principal investigator, Anisha I Patel, Stanford University
- Investigators
- Anisha Patel, MD, MSPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112185
- Sponsor's protocol ID
- 61606
- Other IDs
- 1R01DK127124-01A1
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2021
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Revels K, Ritchie LD, Schmidt L, Blacker L, Ordonez V, McCulloch CE, Patel AI. A cluster randomized controlled trial of a multi-level intervention to promote healthy beverage intake through childcare: Rationale and study protocol. Contemp Clin Trials. 2026 Sep 2:108456. doi: 10.1016/j.cct.2026.108456. Online ahead of print.
PubMed 42685848
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05112185
- Acronym / sponsor ID
- 61606
- Conditions
- Obesity
- Keywords
- water, sugar-sweetened beverages, childcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Davis
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Beverage Access and Promotion | Experimental | Behavioral: Healthy Drinks, Healthy FuturesIntervention group will receive pitchers, water bottles, and cups for serving water at mealtimes and throughout the day, individualized education to help families set healthy drinks goals for their family, and a curricula focused on increasing intake of water and healthy beverages. |
| Control | No intervention | –Usual care. |
Who may qualify
- Ages
- 2 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preschool-age children and families who don't have health conditions that preclude intake of water
Key exclusion criteria (2 listed)
- Children not of preschool-age
- Children and families who do not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Drinks, Healthy FuturesThe 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. | Behavioural | Healthy Beverage Access and Promotion |
Primary outcome
Change in BMI Z-score
Time frame: Baseline, 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.
5 secondary outcomes
Total Caloric Intake From Beverages at Childcare Centers
Time frame: Baseline and 10-months after the start of the study.
Total Caloric Intake From Beverages Outside of Childcare Centers
Time frame: Baseline and 10-months after the start of the study.
Total Water Intake From Beverages at Childcare Centers
Time frame: Baseline, and 10-months after the start of the study.
Total Water Intake Outside of Childcare Centers
Time frame: Baseline, and 10-months after the start of the study.
Beverage Intake
Time frame: Baseline, 6-months, and 10-months after the start of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42685848Revels K, Ritchie LD, Schmidt L, Blacker L, Ordonez V, McCulloch CE, Patel AI. A cluster randomized controlled trial of a multi-level intervention to promote healthy beverage intake through childcare: Rationale and study protocol. Contemp Clin Trials. 2026 Sep 2:108456. doi: 10.1016/j.cct.2026.108456. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anisha Patel, MD, MSPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Drinks, Healthy Futures in people with Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI Z-score (time frame: Baseline, 6-months, and 10-months after the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.