NCT07046351 · University of Virginia
weSIPsmarter: Evaluating a Digital Health Intervention Aimed at Reducing Sugary Drinks Among Rural Head Start Preschoolers and Their Parents
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
weSIPsmarter
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.
BEHAVIORAL
weLearn2Read
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Parents could not have participated in formative work for this study completed under SBS 4522.
Where
- Christiansburg, Virginia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations