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临床试验/NCT03740113
NCT03740113已完成不适用

Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students

University of Virginia2 个研究点 分布在 1 个国家目标入组 1,013 人开始时间: 2018年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,013
试验地点
2
主要终点
Student: SSB Change From Baseline to 7-months (All Participants)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Data from students with major cognitive disabilities that could compromise self-report behavioral data quality will be excluded

结局指标

主要结局

Student: SSB Change From Baseline to 7-months (All Participants)

时间窗: 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.

次要结局

  • Caregiver: SSB Change From Baseline to 7-months (All Participants)(Baseline and 7-months)
  • Student: BMI Z-score Change From Baseline to 7-months(Baseline and 7-months)
  • Caregiver: BMI Change From Baseline to 7-Months(Baseline and 7-months)
  • Student and Caregiver: Quality of Life Change From Baseline to 7-months--Overall Health Rating(Baseline and 7-months)
  • Caregiver: Quality of Life Change From Baseline to 7-months--Unhealthy Days(Baseline and 7-months)
  • Student: Quality of Life Change From Baseline to 7-months--school Related Function(Baseline and 7-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Zoellner, PhD RD

Associate Professor

University of Virginia

研究点 (2)

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