Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03740113 |
| Other study ID # |
2018019500 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2018 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
University of Virginia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
