Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages

March 26, 2025 updated by: Jamie Zoellner, PhD RD, University of Virginia

Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students

Overall Goal: To determine the effectiveness of Kids SIPsmartER in improving sugar-sweetened beverages behaviors among 7th grade students. Secondary aims are to determine (1) changes in secondary student outcomes (e.g. quality of life, BMI z-score, theory-related variables, health and media literacy), (2) changes in caregiver SSB behaviors and home environment, (3) maintenance of outcomes at 19-months post-baseline, (4) assess the reach and representativeness of Kids SIPsmartER, among students and caregivers, and (5) implementation, adoption, and maintenance among teachers and schools.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The intake of sugar-sweetened beverages (SSB, e.g., soda/pop, sweet tea, sports and energy drinks, fruit drinks) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. There are strong and consistent scientific data and systematic reviews documenting relationships among high SSB consumption and numerous chronic health conditions such obesity, some types of obesity-related cancers, diabetes, cardiovascular disease, and dental erosion and decay. Reaching adolescents with behaviorally-focused health programs where they spend the majority of their time, at school, shows promise. However, engaging caregivers who serve as their child's most influential role model as well as the gatekeeper for the home environment may be equally as important in changing adolescents' SSB behaviors. Finally, there is a great need to understand how to support schools and teachers to deliver and maintain evidence-based health education programs, especially among rural schools. Thus, the overarching goal of this proposal is to work in partnership with Appalachian middle schools to implement and evaluate Kids SIPsmartER. Kids SIPsmartER is a 6-month, school-based, behavior and health literacy curriculum aimed at improving SSB behaviors among middle school students. The program also integrates a two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes. Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts. In the proposed cluster-randomized controlled trial, the investigators target 12 middle schools in medically underserved Appalachian counties in southwest Virginia. This study is guided by the RE-AIM (reach, adoption, effectiveness, implementation, and maintenance) framework and is a type 1 hybrid design. The primary aim is to assess changes in SSB behaviors at 7-months among 7th grade students at schools receiving Kids SIPsmartER, as compared to control schools. The investigators will also evaluate changes in secondary student outcomes (e.g., BMI, quality of life, theory-related variables), changes in caregiver outcomes (e.g., SSB behaviors, home SSB environment), and 19-month maintenance of outcomes. The reach and representativeness of Kids SIPsmartER will be assessed. Furthermore, the investigators will use a mixed-methods approach with interviews, surveys, observation, and process evaluation strategies to determine the degree to which teachers implement Kids SIPsmartER as intended and the potential for institutionalization within the schools. The long-term goal of this health promotion and prevention line of research is to establish an effective, scalable, and sustainable multi-level strategy to improve SSB behaviors and reduce SSB-related health inequities and chronic conditions (e.g. obesity, cancer, type II diabetes, heart disease, dental caries) in rural Appalachia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1013

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0717
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 7th grade students in the 12 enrolled schools during the years their school is randomized to one of these cohorts are eligible to participate
  • Parents/caregivers of enrolled middle school students

Exclusion Criteria:

  • Data from students with major cognitive disabilities that could compromise self-report behavioral data quality will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kids SipSmartER
Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes
Behavioral: Kids SipSmartER
Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
No Intervention: Control
Control arm receives no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Student: SSB Change From Baseline to 7-months (All Participants)
Time Frame: Baseline and 7-months
Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.
Baseline and 7-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver: SSB Change From Baseline to 7-months (All Participants)
Time Frame: Baseline and 7-months
Change in ounces of sugar sweetened beverage consumption from Baseline to 7-months as measured via the validated Beverage Intake Questionnaire (BEVQ-15). Participants were asked to report how often and how much of the following sugary drinks they consumed in the past 30 days: regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks. Using standardized and validated scoring procedures, daily totals for each of the sugary beverages were determined by multiplying intake frequency by portion size. These daily total intakes were then summed across the five sugary drink types to obtain a total daily intake, in fluid ounces, of all sugary drinks. Change scores were calculated by subtracting the baseline sugary drink intake from the 7 month follow-up.
Baseline and 7-months
Student: BMI Z-score Change From Baseline to 7-months
Time Frame: Baseline and 7-months
Student BMI z-score: BMI z-score was calculated using the World Health Organization (WHO) growth reference standards. The z-score represents the number of standard deviations a child's BMI is from the population mean for age and sex. A z-score of 0 corresponds to the median BMI of the reference population. Positive values indicate a BMI higher than the reference median, while negative values indicate a BMI lower than the reference median. Higher z-scores generally indicate increased adiposity, with standard clinical thresholds defining overweight as a BMI z-score ≥ 1 and obesity as a BMI z-score ≥ 2.
Baseline and 7-months
Caregiver: BMI Change From Baseline to 7-Months
Time Frame: Baseline and 7-months
Caregiver BMI was calculated from height and weight data using the following equation: kg/m^2
Baseline and 7-months
Student and Caregiver: Quality of Life Change From Baseline to 7-months--Overall Health Rating
Time Frame: Baseline and 7-months
Overall health rating is a Single item question asking to rate general overall health and scored on a 5-point Likert scale from 1=poor to 5=excellent.
Baseline and 7-months
Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days
Time Frame: Baseline and 7-months
Using validated scoring procedures, an unhealthy days score was computed by adding the number of physically and mentally unhealthy days within the past 30 days, with a minimum score of 0 and maximum score of 30 days. Higher scores indicate worse quality of life.
Baseline and 7-months
Student: Quality of Life Change From Baseline to 7-months--school Related Function
Time Frame: Baseline and 7-months
School-related quality of life (QOL) was assessed with the 5-item school functioning subscale of the Pediatric QOL Inventory which used a 5-point Likert scale (i.e., 1 = never a problem, 5 = almost always a problem). Applying validated scoring procedures, items were reverse-scored and linearly transformed to a 0 to 100 scale with higher scores indicating higher school-related QOL.
Baseline and 7-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018019500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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