Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages

NCT ID: NCT03740113

Last Updated: 2025-04-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1013 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2024-06-07

Brief Summary

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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

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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

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Sugary Beverages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized design of schools
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Kids SipSmartER

Intervention Type BEHAVIORAL

Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts

Control

Control arm receives no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Jamie Zoellner, PhD RD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Porter 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.

Reference Type DERIVED
PMID: 40611074 (View on PubMed)

Zoellner 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.

Reference Type DERIVED
PMID: 39236080 (View on PubMed)

Zoellner 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.

Reference Type DERIVED
PMID: 38664715 (View on PubMed)

Yuhas 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.

Reference Type DERIVED
PMID: 36949896 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31233859 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018019500

Identifier Type: -

Identifier Source: org_study_id

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