An interventional study of Kids SipSmartER in Sugary Beverages, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 10 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by University of Virginia · Not applicable, Interventional, and Prevention
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.
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.
University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
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
Control arm receives no intervention
Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
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.
Time frame: Baseline and 7-months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 7-months
| Milestone | Kids SipSmartER | Control |
|---|---|---|
| Started | 547 | 466 |
| Student started | 357 | 308 |
| Caregiver started | 190 | 158 |
| Student completed | 329 | 258 |
| Caregiver completed | 126 | 110 |
| Completed | 455 | 368 |
| Not completed | 92 | 98 |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Student: SSB Change From Baseline to 7-months (All Participants) | -9.9 (-12.2 to -7.6) | -2.7 (-5.4 to -0.1) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: SSB Change From Baseline to 7-months (All Participants) | -8.2 (-12.3 to -4.1) | -6.3 (-11.3 to -1.3) |
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.
| z-score | Kids SipSmartER | Control |
|---|---|---|
| Student: BMI Z-score Change From Baseline to 7-months | 0.02 (-0.01 to 0.05) | -0.018 (-0.09 to 0.06) |
Caregiver BMI was calculated from height and weight data using the following equation: kg/m\^2
| kg/m^2 | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: BMI Change From Baseline to 7-Months | -0.3 (-0.6 to -0.1) | -0.65 (-1.0 to -0.3) |
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.
| units on a scale | Kids SipSmartER | Control |
|---|---|---|
| Students: Overall Health Rating Change | 0.06 (0.003 to 0.1) | 0.03 (-0.1 to 0.2) |
| Caregivers: Overall Health Rating Change | 0.04 (-0.0 to 0.1) | -0.06 (-0.2 to 0.1) |
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.
| units on a scale | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days | -0.3 (-1.1 to 0.6) | -1.7 (-4.3 to 0.9) |
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.
| units on a scale | Kids SipSmartER | Control |
|---|---|---|
| Student: Quality of Life Change From Baseline to 7-months--school Related Function | -1.7 (-3.9 to 0.4) | -3.9 (-7.0 to -.07) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 24 fl oz SSB at Baseline | -23.7 (-29.7 to -17.7) | -9.8 (-13.6 to -6.1) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 12 fl oz SSB at Baseline | -17.5 (-20.8 to -14.2) | -7.1 (-9.1 to -5.1) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Caregiver: SSB Change From Baseline to 7-months for Caregivers Consuming > 8 fl oz SSB at Baseline | -15.0 (-18.6 to -11.5) | -5.8 (-7.2 to -4.5) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Student: SSB Change From Baseline to 7-months for Students Consuming > 24 fl oz SSB at Baseline | -23.0 (-27.0 to -19.0) | -10.3 (-17.7 to -2.9) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Student: SSB Change From Baseline to 7-months for Students Consuming > 12 fl oz SSB at Baseline | -15.5 (-19.0 to -12.0) | -7.4 (-11.2 to -3.7) |
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.
| fluid ounces | Kids SipSmartER | Control |
|---|---|---|
| Student: SSB Change From Baseline to 7-months for Students Consuming > 8 fl oz SSB at Baseline | -13.5 (-16.2 to -10.8) | -5.7 (-8.5 to -2.9) |
Collected over Adverse events were collected through the 19-month follow-up data collection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kids SipSmartER | 0/424 (0%) | 0/424 (0%) | 0/424 (0%) |
| Control | 0/322 (0%) | 0/322 (0%) | 0/322 (0%) |
Analysis population are enrolled students and caregivers who completed the baseline and 7 month assessments
| Age, Continuous(years) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Student Age (years) | 12.6 ± 0.5 | 12.7 ± 0.4 | 12.7 ± 0.5 |
| Caregiver Age (years) | 40.8 ± 7.0 | 40.4 ± 6.2 | 40.6 ± 6.7 |
| Sex/Gender, Customized(Participants) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Student Gender — Female | 182 | 107 | 289 |
| Student Gender — Male | 122 | 109 | 231 |
| Student Gender — Other or unknown | 2 | 4 | 6 |
| Caregiver Gender — Female | 112 | 96 | 208 |
| Caregiver Gender — Male | 6 | 6 | 12 |
| Caregiver Gender — Other or unknown | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Student Ethnicity — Hispanic or Latino | 15 | 9 | 24 |
| Student Ethnicity — Not Hispanic or Latino | 291 | 211 | 502 |
| Student Ethnicity — Unknown or Not Reported | 0 | 0 | 0 |
| Caregiver Ethnicity — Hispanic or Latino | 1 | 0 | 1 |
| Caregiver Ethnicity — Not Hispanic or Latino | 117 | 102 | 219 |
| Caregiver Ethnicity — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Student Race — American Indian or Alaska Native | 42 | 32 | 74 |
| Student Race — Asian | 6 | 6 | 12 |
| Student Race — Native Hawaiian or Other Pacific Islander | 3 | 4 | 7 |
| Student Race — Black or African American | 9 | 10 | 19 |
| Student Race — White | 235 | 155 | 390 |
| Student Race — More than one race | 0 | 0 | 0 |
| Student Race — Unknown or Not Reported | 11 | 13 | 24 |
| Caregiver Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Caregiver Race — Asian | 2 | 1 | 3 |
| Caregiver Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Caregiver Race — Black or African American | 3 | 4 | 7 |
| Caregiver Race — White | 105 | 88 | 193 |
| Caregiver Race — More than one race | 0 | 0 | 0 |
| Caregiver Race — Unknown or Not Reported | 7 | 8 | 15 |
| Region of Enrollment(participants) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| United States | 424 | 322 | 746 |
| BMI status(Participants) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Student BMI Status — Underweight (student BMI < 5th%; caregiver BMI < 18.5 kg/m2) | 5 | 4 | 9 |
| Student BMI Status — Healthy Weight (student BMI 5th- <85th%; caregiver BMI 18.5-24.9 kg/m2) | 142 | 103 | 245 |
| Student BMI Status — Overweight (student BMI 85th-<95th%; caregiver BMI 25-29.9 kg/m2) | 57 | 39 | 96 |
| Student BMI Status — Obese (student BMI 95th -<99th%; caregiver BMI 30-34.9 kg/m2) | 58 | 40 | 98 |
| Student BMI Status — Severe Obesity (student BMI >/= 99th%; caregiver BMI >/= 30 kg/m2) | 33 | 15 | 48 |
| Student BMI Status — Other or unknown | 11 | 19 | 30 |
| Caregiver BMI Status — Underweight (student BMI < 5th%; caregiver BMI < 18.5 kg/m2) | 1 | 3 | 4 |
| Caregiver BMI Status — Healthy Weight (student BMI 5th- <85th%; caregiver BMI 18.5-24.9 kg/m2) | 16 | 28 | 44 |
| Caregiver BMI Status — Overweight (student BMI 85th-<95th%; caregiver BMI 25-29.9 kg/m2) | 31 | 27 | 58 |
| Caregiver BMI Status — Obese (student BMI 95th -<99th%; caregiver BMI 30-34.9 kg/m2) | 26 | 16 | 42 |
| Caregiver BMI Status — Severe Obesity (student BMI >/= 99th%; caregiver BMI >/= 30 kg/m2) | 34 | 21 | 55 |
| Caregiver BMI Status — Other or unknown | 10 | 7 | 17 |
| Student BMI z-score(z-score) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Mean | 0.9 ± 1.1 | 1.0 ± 1.0 | 0.9 ± 1.1 |
| Student BMI percentile(percentile) | Kids SipSmartER | Control | Total |
|---|---|---|---|
| Mean | 73.2 ± 27.1 | 75.8 ± 24.6 | 74.1 ± 26.2 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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