weSIPsmarter for Reducing Sugary Drinks

Overseen By Jamie Zoellner, PhD RD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Prior study participation

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

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

744 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called weSIPsmarter can reduce sugary drink consumption among preschool-aged children and their parents. The program includes interactive activities such as tracking beverage habits and setting goals, along with resources like drinking water vouchers for families. Families with children aged 2 to 5, enrolled in a participating Head Start program, and with a legal guardian willing to participate, are suitable for this study. Researchers will divide participants into two groups: one will try the weSIPsmarter program, while the other will focus on a reading initiative. As an unphased trial, this study offers families the opportunity to contribute to important research that could improve children's health and habits.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the weSIPsmarter program is safe for reducing sugary drink consumption in preschool-aged children and their parents?

Research shows that the weSIPsmarter program aims to reduce sugary drink consumption by involving parents as key influencers. The Institutional Review Board (IRB) at the University of Virginia has reviewed and approved the program, ensuring it meets safety and ethical standards to protect participants.

weSIPsmarter offers a structured approach, including progress tracking and goal setting. It also provides resources like a help line and water vouchers for families concerned about tap water quality. These components support safe and effective behavior change without causing physical harm.

Previous research on similar programs has not reported any safety issues or negative effects. This absence of negative safety data suggests that participants likely tolerate the program well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the weSIPsmarter program because it offers a fresh approach to reducing sugary drink consumption by engaging parents as key agents of change. Unlike traditional methods that might focus solely on educating children, this program is highly interactive and structured, using technology like ecological momentary assessment (EMA) for real-time self-monitoring and feedback. It also includes practical components like goal setting, action planning, and even drinking water vouchers for families concerned about tap water quality. These innovative features aim to create lasting behavioral changes in both children and parents, which could make a significant difference in promoting healthier beverage choices.

What evidence suggests that the weSIPsmarter program is effective for reducing sugary drink consumption?

Research has shown that programs like weSIPsmarter, one of the study arms in this trial, can effectively reduce sugary drink consumption by involving parents and encouraging self-monitoring. Studies have found that active parental involvement leads children to drink fewer sugary beverages and make healthier choices. Tools that enable real-time habit tracking have successfully promoted healthier behaviors. Setting goals and making action plans have also proven effective for achieving lasting change. Providing vouchers for drinking water addresses barriers such as concerns about water quality, ensuring families access healthier options. Together, these elements support the potential effectiveness of weSIPsmarter.

Are You a Good Fit for This Trial?

This trial is for families with preschool-aged children enrolled in rural Head Start programs. It's designed to see if a digital health intervention can help them cut down on sugary drinks.

Inclusion Criteria

Children must be enrolled in a participating Head Start program

Our Head Start site is committed and capable of fulfilling the project's requirements.

Head Start sites must fall within the planned Appalachia and Black Belt regions

Exclusion Criteria

Parents must not have participated in formative work for this study completed under SBS 4522.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of existing evidence-based sugary drink interventions to a digital format using a user-centered design process

Not specified

Treatment

Participants engage in the weSIPsmarter program, which includes self-monitoring of beverage behaviors, action planning, and use of a resource help line

9 weeks

3 assessment periods (pre, 9-week post, and 12-month follow-up)

Follow-up

Participants are monitored for maintenance of outcomes and secondary measures such as diet quality and BMI

12 months

What Are the Treatments Tested in This Trial?

Interventions

• weSIPsmarter

Trial Overview The study compares the weSIPsmarter program against a control group, aiming to assess its effectiveness in reducing sugary drink intake among both kids and their parents.

How Is the Trial Designed?

Group I: weSIPsmarter Experimental Treatment 1 Intervention

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.

Group II: weLearn2Read Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. wesipsmarter.org wesipsmarter.org/

weSIPsmarter: Welcome weSIPsmarter is run by researchers at the University of Virginia. It is funded by the National Institutes of Health. To learn more, click the Study, Join, Team ...

2. welearn2read.org welearn2read.org/pages/study

Study | weLearn2Read weSIPsmarter has been reviewed and approved by the University of Virginia IRB. ... The primary role of the IRB is to protect the safety and welfare of human ...

3. reporter.nih.gov reporter.nih.gov/search/z-J_XMn0eEiW4d30Ws92_w/project-details/10766732

Preventing Childhood Obesity Through Youth Empowerment Data will be collected at baseline, 2 months, 6 months, and 12 months and include child anthropometrics, SSB and water intake, and youth empowerment.

4. epa.gov epa.gov/pesticide-worker-safety/agricultural-worker-protection-standard-wps

Agricultural Worker Protection Standard (WPS) | US EPA Safety Data Sheets for pesticides applied on the establishment; and; Pesticide safety information that includes emergency information.

5. ctv.veeva.com ctv.veeva.com/study/wesipsmarter-evaluating-a-digital-health-intervention-aimed-at-reducing-sugary-drinks-among-rural-h

weSIPsmarter: Evaluating a Digital Health Intervention Aimed ... This new program, called weSIPsmarter, will be a highly interactive, structured program consisting of multiple evidence-based behavioral ...