Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740113
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Jamie Zoellner, PhD RD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Sugary Beverages Behavioral: Kids SipSmartER Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized design of schools
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2023

Arm Intervention/treatment
Experimental: Kids SipSmartER
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
Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts

No Intervention: Control
Control arm receives no intervention



Primary Outcome Measures :
  1. sugar sweetened beverages [ Time Frame: 6 months ]
    ounces of sugar sweetened beverage consumption


Secondary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]
    weight and height will be combined to report BMI in kg/m^2

  2. Health-related quality of life [ Time Frame: 6 months ]
    number of unhealthy days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740113


Locations
Layout table for location information
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908-0717
Sponsors and Collaborators
University of Virginia
Virginia Polytechnic Institute and State University

Layout table for additonal information
Responsible Party: Jamie Zoellner, PhD RD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03740113     History of Changes
Other Study ID Numbers: 2018019500
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jamie Zoellner, PhD RD, University of Virginia:
Sugar sweetened beverages
health disparities
Appalachia