Sugary BeveragesNCT07046351
weSIPsmarter: Evaluating a Digital Health Intervention Aimed at Reducing Sugary Drinks Among Rural Head Start Preschoolers and Their Parents
A study testing weSIPsmarter and weLearn2Read in people with Sugary Beverages, run by University of Virginia at 1 site in United States.
Trial summary
This study will include 12 rural Head Start programs, randomly assigned to one of two groups: weSIPsmarter vs. control. The main goal is to find out if weSIPsmarter helps reduce sugary drink consumption in preschool-aged children and their parents. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sugary Beverages
- What is being tested?
- weSIPsmarter and weLearn2Read
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Head Start sites: Head Start sites will be located in or adjacent to a rural county (RUCC 4-9), fall within the planned Appalachia and Black Belt regions, have an enrollment of 120 families or more, and exhibit commitment and capacity to the scope of work.
- Participants: Children enrolled must be between the ages of 2 and 5 year, be enrolled in a participating Head Start, and have a legal guardian ("parent," able under law to consent for their child to participate) who has enrolled in the trial themselves and provided consent for the child. Only one parent-child dyad per household is eligible to participate in the trial.
Who cannot join
- Parents could not have participated in formative work for this study completed under SBS 4522.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Christiansburg, Virginia, 24073
Jamie Zoellner, jz9q@virginia.edu
About this study
Official title: weSIPsmarter: An Adaptation and Efficacy Trial to Evaluate a Behaviorally Based Digital Health Intervention Aimed at Reducing Sugary Drinks Among Rural Head Start Preschoolers and Their Parents
This study will include 12 rural Head Start programs, randomly assigned to one of two groups: weSIPsmarter vs. control. The main goal is to find out if weSIPsmarter helps reduce sugary drink consumption in preschool-aged children and their parents.
Read the detailed description
Sugary drinks are the largest single source of calories in the US diet and contribute approximately 8% and 7% of total energy intake for US youth and adults, respectively. Unfortunately, the prevalence of daily sugary drink intake is significantly higher in nonmetropolitan US counties, relative to metropolitan counties (adjusted prevalence ratio = 1.32). Also, an estimated 47% of children age 2-5 consume sugary drinks daily. High sugary drink intake contributes to the development of numerous chronic conditions, including cancer. Despite convincing data on risky sugary drink behaviors in rural counties and among preschool-aged children, there are substantial gaps in the intervention literature. For example, few sugary drink interventions have targeted the needs of US rural regions, few have effectively used scalable technology to reduce child's sugary drinks, and most fail to report on external validity factors. This research addresses these needs and builds on the research team's extensive digital Health expertise and successful sugary drink research within rural communities. Head Starts across defined rural areas (i.e., RUCC 4-9) in Appalachia and the southern Black Belt will be included. The intervention targets parents as the agent of change and aims to improve parent-child dyad outcomes. Phase 1 is guided by the Adaptome framework. In partnership with rural Head Start staff and parents, a user-centered design process will be applied to adapt an existing evidence-based sugary drink interventions to a digital intervention. This new program, called weSIPsmarter, will be a highly interactive, structured program consisting of multiple evidence-based behavioral change components, including use of ecological momentary assessment (EMA) to encourage self-monitoring of beverage behaviors and parenting feeding practices, action planning, a resource help line, and drinking water vouchers for families with concerns related to in-home tap water quality. Phase 2 is guided by RE-AIM and includes a 2 group cluster RCT design [weSIPsmarter vs. control] with 3 assessment (pre, 9-week post, and 12-month follow-up) periods. Twelve Head Start center clusters with an average of 31 parent-child dyads per cluster (total of 372 parent-child dyads) will be randomized. It is hypothesized that weSIPsmarter will be more efficacious at reducing sugary drink consumption than control. Changes in secondary outcomes will also be evaluated, including parent-child dyad outcomes (e.g., diet quality, water, BMI, QOL, behavioral theory constructs) and maintenance at 12-months post intervention. Additional secondary aims will examine reach, describe parent engagement, and apply a mixed-methods process evaluation to evaluate adoption and implementation among Head Starts. Mediators and moderators (e.g., social determinant of health indicators) to engagement and efficacy outcomes will be explored, along with organizational-level maintenance. The long-term goal of this primary prevention research is to develop an efficacious sugary drink reduction intervention that has high reach among rural, low socioeconomic, children ages 2-5 and their parents.
- Conditions
- Sugary Beverages
- Being tested
- weSIPsmarter, weLearn2Read
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weSIPsmarterBehavioural
weSIPsmarter is grounded by the Theory of Planned Behavior as well as Satter's Feeding Dynamic Model. weSIPsmarter will also integrate relevant behavior change techniques and target concepts from health literacy, health numerary, media literacy, and eHealth literacy.
weLearn2ReadBehavioural
weLearn2Read participants will have access to a website with resources to improve reading readiness, including 6 structured parent lessons, setting reading goals, and 6 children's books (one mailed home each week), and options to receive weekly reminders (e.g., email or text) to encourage reading readiness.
| Study group | Role | What they receive |
|---|---|---|
| weSIPsmarter | Experimental | weSIPsmarter, targets parents as the agent of change and will be a highly interactive, structured program. It will consist of multiple evidence-based behavioral change components, including use of ecological momentary assessment (EMA) to encourage self-monitoring of beverage behaviors and parenting feeding practices, goal setting and action planning, a resource help line, and drinking water vouchers for families with concerns related to in-home tap water quality. weSIPsmarter participants will be engaged in completing six Cores, tracking daily sugary drink intake for parents and child, and completing daily weigh-ins for parents only. Receives: Behavioral: weSIPsmarter |
| weLearn2Read | Other | weLearn2Read participants will be engaged in completing six Cores. Participants will also receive 6 children's books, matched to each Core, which will be mailed to the participants' homes. Parents in the weLearn2Read control can also opt to receive reminders (email or text) to encourage reading readiness. Receives: Behavioral: weLearn2Read |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child sugar-sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire for Preschool-aged Children (BEVQ-PS) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Measured: Baseline and 9 weeks
Secondary outcomes (23)
Child sugar sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire for Preschool-aged Children (BEVQ-PS) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Measured: 12 month
Parent sugar-sweetened beverage (SSB) ounces
The Beverage Intake Questionnaire (BEVQ-15) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
Measured: Baseline, 9 weeks, 12 months
Child Weight in pounds
Measured using a cellular enabled in-home BodyTrace digital scale
Measured: Baseline, 9 weeks, 12 months
Child Height in feet and inches
Measured via stadiometer
Measured: Baseline, 9 weeks, 12 months
Child Body Mass Index (BMI) Percentile
Child's Body Mass Index (BMI) will be calculated using the standard formula: weight(kg)/height(m)2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19.
Measured: Baseline, 9 weeks, 12 months
Parent Weight in pounds
Measured using a cellular enabled in-home BodyTrace digital scale.
Measured: Baseline, 9 weeks, 12 months
Parent Height in feet and inches
Self-reported
Measured: Baseline
Parent Body Mass Index (BMI)
Parent's Body Mass Index (BMI) will be calculated using the standard formula: weight(kg)/height(m)2.
Measured: Baseline, 9 weeks, 12 months
Parent number of unhealthy days
The number of unhealth days, a measure of Quality of Life (QOL), will be assessed using Center's for Disease Control Healthy Day module. Higher number of days means worse outcome.
Measured: Baseline, 9 weeks, 12 months
Proportion of parents with limited health literacy
Assessed using the Newest Vital Sign. Scores range from 0-6 with 0-4 considered limited health literacy and 5-6 considered to be adequate health literacy.
Measured: Baseline, 9 weeks, 12 months
Parent sugary-sweetened beverage (SSB) media literacy score
Measured with sugary-sweetened beverage (SSB) media literacy instrument which includes 6 items measured on a 7-point Likert scale (1, strongly disagree; 7, strongly agree). Scores range from 7-42; Higher scores equate to higher SSB media literacy.
Measured: Baseline, 9 weeks, 12 months
eHealth digital literacy score
The eHEALS digital literacy test is an 8-item measure of eHealth literacy developed to measure the participants combined knowledge, comfort and perceived skills at finding, evaluating and applying electronic health information to health problems. The test is measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.
Measured: Baseline, 9 weeks, 12 months
Division of Responsibility (DOR) feeding approach score
Assessed using Satter Parent-Child Feeding Measure (sDOR.2-6y™). Includes 12 times, with scores ranging from 0-32. Higher scores indicate greater adherence to the Division of Responsibility (DOR) feeding approach.
Measured: Baseline, 9 weeks, 12 months
Frequency of sugar-sweetened beverages (SSB) in the home
Home availability of 7 categories of sugar sweetened beverages (SSB) in the home. Responses are on a 5-point Likert scale (1, never; 5, always). Scores range from 7-35, with higher scores meaning higher home availability of SSB.
Measured: Baseline, 9 weeks, 12 months
Child fruits and vegetables (cup equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into fruits and vegetables cup equivalents per day.
Measured: Baseline, 9 weeks, 12 months
Child added sugars (teaspoon equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into added sugars teaspoon equivalents per day.
Measured: Baseline, 9 weeks, 12 months
Child added sugars from sugar-sweetened beverages (teaspoon equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into added sugars from sugar-sweetened beverages teaspoon equivalents per day.
Measured: Baseline, 9 weeks, 12 months
Child dairy (cup equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into dairy cup equivalents per day.
Measured: Baseline, 9 weeks, 12 months
Child whole grains (ounce equivalents per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into whole grains ounce equivalents per day.
Measured: Baseline, 9 weeks, 12 months
Child calcium (milligrams per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into calcium milligrams per day.
Measured: Baseline, 9 weeks, 12 months
Child fiber (grams per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into fiber grams per day.
Measured: Baseline, 9 weeks, 12 months
Child red meat (times per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into red meat times per day.
Measured: Baseline, 9 weeks, 12 months
Child processed meat (times per day)
Assessed using the Dietary Screener Questionnaire (DSQ). Validated scoring algorithms are used to convert frequency of food items into processed meat times per day.
Measured: Baseline, 9 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start6 Aug 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sugary BeveragesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Model description
- Cluster randomized design
- Masking
- None (open label)
- Enrolment
- 744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jamie Zoellner, PhD RD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046351
- Sponsor's protocol ID
- IRB-SBS-6590
- Other IDs
- R01CA282436
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the deidentified behavioral-related data (as described it the outcome measure section) will be achieved in the University of Virginia's data repository, LibraData. The clinical trial outcome data will be findable and identifiable in LibraData via a persistent identifier (DOI), which is created for each LibraData dataset.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- weSIPsmarter: An Adaptation and Efficacy Trial to Evaluate a Behaviorally Based Digital Health Intervention Aimed at Reducing Sugary Drinks Among Rural Head Start Preschoolers and Their Parents
- ClinicalTrials.gov ID
- NCT07046351
- Acronym / sponsor ID
- IRB-SBS-6590
- Conditions
- Sugary Beverages
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 744 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include 12 rural Head Start programs, randomly assigned to one of two groups: weSIPsmarter vs. control. The main goal is to find out if weSIPsmarter helps reduce sugary drink consumption in preschool-aged children and their parents.
Detailed description
Sugary drinks are the largest single source of calories in the US diet and contribute approximately 8% and 7% of total energy intake for US youth and adults, respectively. Unfortunately, the prevalence of daily sugary drink intake is significantly higher in nonmetropolitan US counties, relative to metropolitan counties (adjusted prevalence ratio = 1.32). Also, an estimated 47% of children age 2-5 consume sugary drinks daily. High sugary drink intake contributes to the development of numerous chronic conditions, including cancer. Despite convincing data on risky sugary drink behaviors in rural counties and among preschool-aged children, there are substantial gaps in the intervention literature. For example, few sugary drink interventions have targeted the needs of US rural regions, few have effectively used scalable technology to reduce child's sugary drinks, and most fail to report on external validity factors. This research addresses these needs and builds on the research team's extensive digital Health expertise and successful sugary drink research within rural communities. Head Starts across defined rural areas (i.e., RUCC 4-9) in Appalachia and the southern Black Belt will be included. The intervention targets parents as the agent of change and aims to improve parent-child dyad outcomes. Phase 1 is guided by the Adaptome framework. In partnership with rural Head Start staff and parents, a user-centered design process will be applied to adapt an existing evidence-based sugary drink interventions to a digital intervention. This new program, called weSIPsmarter, will be a highly interactive, structured program consisting of multiple evidence-based behavioral change components, including use of ecological momentary assessment (EMA) to encourage self-monitoring of beverage behaviors and parenting feeding practices, action planning, a resource help line, and drinking water vouchers for families with concerns related to in-home tap water quality. Phase 2 is guided by RE-AIM and includes a 2 group cluster RCT design [weSIPsmarter vs. control] with 3 assessment (pre, 9-week post, and 12-month follow-up) periods. Twelve Head Start center clusters with an average of 31 parent-child dyads per cluster (total of 372 parent-child dyads) will be randomized. It is hypothesized that weSIPsmarter will be more efficacious at reducing sugary drink consumption than control. Changes in secondary outcomes will also be evaluated, including parent-child dyad outcomes (e.g., diet quality, water, BMI, QOL, behavioral theory constructs) and maintenance at 12-months post intervention. Additional secondary aims will examine reach, describe parent engagement, and apply a mixed-methods process evaluation to evaluate adoption and implementation among Head Starts. Mediators and moderators (e.g., social determinant of health indicators) to engagement and efficacy outcomes will be explored, along with organizational-level maintenance. The long-term goal of this primary prevention research is to develop an efficacious sugary drink reduction intervention that has high reach among rural, low socioeconomic, children ages 2-5 and their parents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized design
| Arm | Type | Receives |
|---|---|---|
| weSIPsmarter | Experimental | Behavioral: weSIPsmarterweSIPsmarter, targets parents as the agent of change and will be a highly interactive, structured program. It will consist of multiple evidence-based behavioral change components, including use of ecological momentary assessment (EMA) to encourage self-monitoring of beverage behaviors and parenting feeding practices, goal setting and action planning, a resource help line, and drinking water vouchers for families with concerns related to in-home tap water quality. weSIPsmarter participants will be engaged in completing six Cores, tracking daily sugary drink intake for parents and child, and completing daily weigh-ins for parents only. |
| weLearn2Read | Other | Behavioral: weLearn2ReadweLearn2Read participants will be engaged in completing six Cores. Participants will also receive 6 children's books, matched to each Core, which will be mailed to the participants' homes. Parents in the weLearn2Read control can also opt to receive reminders (email or text) to encourage reading readiness. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Head Start sites: Head Start sites will be located in or adjacent to a rural county (RUCC 4-9), fall within the planned Appalachia and Black Belt regions, have an enrollment of 120 families or more, and exhibit commitment and capacity to the scope of work.
- Participants: Children enrolled must be between the ages of 2 and 5 year, be enrolled in a participating Head Start, and have a legal guardian ("parent," able under law to consent for their child to participate) who has enrolled in the trial themselves and provided consent for the child. Only one parent-child dyad per household is eligible to participate in the trial.
Key exclusion criteria (1 listed)
- Parents could not have participated in formative work for this study completed under SBS 4522.
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 |
|---|---|---|
| weSIPsmarterweSIPsmarter is grounded by the Theory of Planned Behavior as well as Satter's Feeding Dynamic Model. weSIPsmarter will also integrate relevant behavior change techniques and target concepts from health literacy, health numerary, media literacy, and eHealth literacy. | Behavioural | weSIPsmarter |
| weLearn2ReadweLearn2Read participants will have access to a website with resources to improve reading readiness, including 6 structured parent lessons, setting reading goals, and 6 children's books (one mailed home each week), and options to receive weekly reminders (e.g., email or text) to encourage reading readiness. | Behavioural | weLearn2Read |
Primary outcome
Child sugar-sweetened beverage (SSB) ounces
Time frame: Baseline and 9 weeks
The Beverage Intake Questionnaire for Preschool-aged Children (BEVQ-PS) assesses the intake of sugar-sweetened beverages (SSBs) by measuring the frequency and amount (in ounces) across beverage categories. The ounces are then then aggregated to calculate the total SSB intake in ounces.
23 secondary outcomes
Child sugar sweetened beverage (SSB) ounces
Time frame: 12 month
Parent sugar-sweetened beverage (SSB) ounces
Time frame: Baseline, 9 weeks, 12 months
Child Weight in pounds
Time frame: Baseline, 9 weeks, 12 months
Child Height in feet and inches
Time frame: Baseline, 9 weeks, 12 months
Child Body Mass Index (BMI) Percentile
Time frame: Baseline, 9 weeks, 12 months
Parent Weight in pounds
Time frame: Baseline, 9 weeks, 12 months
Parent Height in feet and inches
Time frame: Baseline
Parent Body Mass Index (BMI)
Time frame: Baseline, 9 weeks, 12 months
Parent number of unhealthy days
Time frame: Baseline, 9 weeks, 12 months
Proportion of parents with limited health literacy
Time frame: Baseline, 9 weeks, 12 months
Parent sugary-sweetened beverage (SSB) media literacy score
Time frame: Baseline, 9 weeks, 12 months
eHealth digital literacy score
Time frame: Baseline, 9 weeks, 12 months
Division of Responsibility (DOR) feeding approach score
Time frame: Baseline, 9 weeks, 12 months
Frequency of sugar-sweetened beverages (SSB) in the home
Time frame: Baseline, 9 weeks, 12 months
Child fruits and vegetables (cup equivalents per day)
Time frame: Baseline, 9 weeks, 12 months
Child added sugars (teaspoon equivalents per day)
Time frame: Baseline, 9 weeks, 12 months
Child added sugars from sugar-sweetened beverages (teaspoon equivalents per day)
Time frame: Baseline, 9 weeks, 12 months
Child dairy (cup equivalents per day)
Time frame: Baseline, 9 weeks, 12 months
Child whole grains (ounce equivalents per day)
Time frame: Baseline, 9 weeks, 12 months
Child calcium (milligrams per day)
Time frame: Baseline, 9 weeks, 12 months
Child fiber (grams per day)
Time frame: Baseline, 9 weeks, 12 months
Child red meat (times per day)
Time frame: Baseline, 9 weeks, 12 months
Child processed meat (times per day)
Time frame: Baseline, 9 weeks, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes. All the deidentified behavioral-related data (as described it the outcome measure section) will be achieved in the University of Virginia's data repository, LibraData. The clinical trial outcome data will be findable and identifiable in LibraData via a persistent identifier (DOI), which is created for each LibraData dataset.
Related trials for Sugary Beverages
Recruiting
A Sensory Strategy to Cut Sugary Beverages in African/American and Latine Adolescents
Obesity, Adolescent, Dietary Sugars
Active, not recruiting
iSIPsmarter: A Pilot RCT to Evaluate a Web-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults
Diet Habit, Sugar-Sweetened Beverages
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weSIPsmarter and weLearn2Read in people with Sugary Beverages, run by University of Virginia 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Zoellner, PhD RD ((434) 924-5999, jz9q@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child sugar-sweetened beverage (SSB) ounces (time frame: Baseline and 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.