Recruiting

weSIPsmarter

Sponsor:

University of Virginia

Code:

NCT07046351

Conditions

Sugary Beverages

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

weSIPsmarter

weLearn2Read

Study Details

Brief 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.

Conditions

Sugary Beverages

Study ID

NCT07046351

Start date

Aug 6, 2025

Status verified date

Nov, 2025

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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.
2. 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.

Study Design

Enrollment

744 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: weSIPsmarter

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.

other: weLearn2Read

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.

Interventions

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.

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 measure

  • Child sugar-sweetened beverage (SSB) ounces [ Time Frame: Baseline and 9 weeks ]

Central Contacts and Locations

Central contacts

Jamie Zoellner, PhD RD

(434) 924-5999jz9q@virginia.edu

Locations

University of Virginia

Recruiting

Christiansburg, Virginia, United States, 24073

Contacts

Jamie Zoellner

jz9q@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Dec 16, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-12-16.