Clinical trial NCT03740113: Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages
Official title: Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sugary Beverages
Keywords: Sugar sweetened beverages
health disparities
Appalachia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 1013
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized design of schools
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Student: SSB Change From Baseline to 7-months (All Participants)
timeFrame: Baseline and 7-months
Secondary outcomes:
measure: Caregiver: SSB Change From Baseline to 7-months (All Participants)
timeFrame: Baseline and 7-months
measure: Student: BMI Z-score Change From Baseline to 7-months
timeFrame: Baseline and 7-months
measure: Caregiver: BMI Change From Baseline to 7-Months
timeFrame: Baseline and 7-months
measure: Student and Caregiver: Quality of Life Change From Baseline to 7-months--Overall Health Rating
timeFrame: Baseline and 7-months
measure: Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days
timeFrame: Baseline and 7-months
measure: Student: Quality of Life Change From Baseline to 7-months--school Related Function
timeFrame: Baseline and 7-months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: 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.