Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages

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: Completed
• Conditions: Sugary Beverages
• Intervention / Treatment: Behavioral: Kids SipSmartER

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: Interventional
• Enrollment (Actual): 1013
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Student: SSB Change From Baseline to 7-months (All Participants)	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

Outcome Measure	Measure Description	Time Frame
Caregiver: SSB Change From Baseline to 7-months (All Participants)	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	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	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	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	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	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

• Sponsor: University of Virginia
• Collaborators: Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• Zoellner JM, Porter KJ, You W, Chow PI, Ritterband LM, Yuhas M, Loyd A, McCormick BA, Brock DP. Kids SIPsmartER, a cluster randomized controlled trial and multi-level intervention to improve sugar-sweetened beverages behaviors among Appalachian middle-school students: Rationale, design & methods. Contemp Clin Trials. 2019 Aug;83:64-80. doi: 10.1016/j.cct.2019.06.011. Epub 2019 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: health disparities; Appalachia; Sugar sweetened beverages
• Other Study ID 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