Sugary BeveragesNCT03740113
Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages
A study testing Kids SipSmartER in people with Sugary Beverages, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugary Beverages
- What is being tested?
- Kids SipSmartER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Data from students with major cognitive disabilities that could compromise self-report behavioral data quality will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908-0717
About this study
Official title: 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.
Read the 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.
- Conditions
- Sugary Beverages
- Being tested
- Kids SipSmartER
- Keywords
- Sugar sweetened beverages, health disparities, Appalachia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kids SipSmartERBehavioural
Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
| Study group | Role | What they receive |
|---|---|---|
| Kids SipSmartER | Experimental | 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 Receives: Behavioral: Kids SipSmartER |
| Control | No intervention | Control arm receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 7-months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 7-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start15 Aug 2018
- Primary completion30 May 2022
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sugary BeveragesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized design of schools
- Masking
- None (open label)
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Zoellner, PhD RD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740113
- Sponsor's protocol ID
- 2018019500
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2018
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirkpatrick BM, Brock DP, Reid AL, Porter KJ, Markwalter TH, You W, Chow PI, Ritterband L, Zoellner J. An SMS intervention to reduce caregiver's sugar-sweetened beverages: impacts on theoretical constructs and parenting practices from a randomized controlled trial in rural appalachia. J Nutr Sci. 2025 Dec 19;14:e91. doi: 10.1017/jns.2025.10057. eCollection 2025.
PubMed 41496860Porter KJ, Reid AL, Markwalter T, Kirkpatrick BM, Walters HG, Helms CE, Salyers L, Zoellner JM. Using implementation strategies to promote the maintenance of Kids SIPsmartER in rural Appalachian middle schools: a process evaluation. BMC Public Health. 2025 Jul 3;25(1):2324. doi: 10.1186/s12889-025-23554-x.
PubMed 40611074Zoellner JM, Porter KJ, Reid A, Markwalter T, Kirkpatrick B, Brock DP, You W. Comparison of Researcher-Led versus Teacher-Led effectiveness and fidelity: A Hybrid Type 1 study of Kids SIPsmartER in Appalachia middle schools. Transl Behav Med. 2024 Oct 6;14(10):578-587. doi: 10.1093/tbm/ibae041.
PubMed 39236080Zoellner JM, You W, Porter K, Kirkpatrick B, Reid A, Brock D, Chow P, Ritterband L. Kids SIPsmartER reduces sugar-sweetened beverages among Appalachian middle-school students and their caregivers: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Apr 25;21(1):46. doi: 10.1186/s12966-024-01594-7.
PubMed 38664715Yuhas M, Brock DP, Ritterband LM, Chow PI, Porter KJ, Zoellner JM. Retention and engagement of rural caregivers of adolescents in a short message service intervention to reduce sugar-sweetened beverage intake. Digit Health. 2023 Mar 16;9:20552076231160324. doi: 10.1177/20552076231160324. eCollection 2023 Jan-Dec.
PubMed 36949896Zoellner 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.
PubMed 31233859
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students
- ClinicalTrials.gov ID
- NCT03740113
- Acronym / sponsor ID
- 2018019500
- Conditions
- Sugary Beverages
- Keywords
- Sugar sweetened beverages, health disparities, Appalachia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized design of schools
| Arm | Type | Receives |
|---|---|---|
| Kids SipSmartER | Experimental | Behavioral: Kids SipSmartERKids 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 |
| Control | No intervention | –Control arm receives no intervention |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Data from students with major cognitive disabilities that could compromise self-report behavioral data quality will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kids SipSmartERKids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts | Behavioural | Kids SipSmartER |
Primary outcome
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.
6 secondary outcomes
Caregiver: SSB Change From Baseline to 7-months (All Participants)
Time frame: Baseline and 7-months
Student: BMI Z-score Change From Baseline to 7-months
Time frame: Baseline and 7-months
Caregiver: BMI Change From Baseline to 7-Months
Time frame: 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
Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days
Time frame: Baseline and 7-months
Student: Quality of Life Change From Baseline to 7-months--school Related Function
Time frame: Baseline and 7-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41496860Kirkpatrick BM, Brock DP, Reid AL, Porter KJ, Markwalter TH, You W, Chow PI, Ritterband L, Zoellner J. An SMS intervention to reduce caregiver's sugar-sweetened beverages: impacts on theoretical constructs and parenting practices from a randomized controlled trial in rural appalachia. J Nutr Sci. 2025 Dec 19;14:e91. doi: 10.1017/jns.2025.10057. eCollection 2025.
- Derived from this study: PubMed 40611074Porter KJ, Reid AL, Markwalter T, Kirkpatrick BM, Walters HG, Helms CE, Salyers L, Zoellner JM. Using implementation strategies to promote the maintenance of Kids SIPsmartER in rural Appalachian middle schools: a process evaluation. BMC Public Health. 2025 Jul 3;25(1):2324. doi: 10.1186/s12889-025-23554-x.
- Derived from this study: PubMed 39236080Zoellner JM, Porter KJ, Reid A, Markwalter T, Kirkpatrick B, Brock DP, You W. Comparison of Researcher-Led versus Teacher-Led effectiveness and fidelity: A Hybrid Type 1 study of Kids SIPsmartER in Appalachia middle schools. Transl Behav Med. 2024 Oct 6;14(10):578-587. doi: 10.1093/tbm/ibae041.
- Derived from this study: PubMed 38664715Zoellner JM, You W, Porter K, Kirkpatrick B, Reid A, Brock D, Chow P, Ritterband L. Kids SIPsmartER reduces sugar-sweetened beverages among Appalachian middle-school students and their caregivers: a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Apr 25;21(1):46. doi: 10.1186/s12966-024-01594-7.
- Derived from this study: PubMed 36949896Yuhas M, Brock DP, Ritterband LM, Chow PI, Porter KJ, Zoellner JM. Retention and engagement of rural caregivers of adolescents in a short message service intervention to reduce sugar-sweetened beverage intake. Digit Health. 2023 Mar 16;9:20552076231160324. doi: 10.1177/20552076231160324. eCollection 2023 Jan-Dec.
- Derived from this study: PubMed 31233859Zoellner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kids SipSmartER in people with Sugary Beverages, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student: SSB Change From Baseline to 7-months (All Participants) (time frame: Baseline and 7-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740113, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.