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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jun 9, 2022
Date Accepted: Jun 24, 2022

The final, peer-reviewed published version of this preprint can be found here:

A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial

Fleary SA

A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial

JMIR Res Protoc 2022;11(8):e40191

DOI: 10.2196/40191

PMID: 35972787

PMCID: 9428776

Web-based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial

  • Sasha A Fleary

ABSTRACT

Background:

Predictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents’ obesogenic behavior. However, most existing adolescent interventions target these variables in isolation. Further, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents’ obesity status. Yet, HL has not been included in obesity interventions targeting adolescents.

Objective:

The aims of this study are to pilot the feasibility of a two-armed digital obesity prevention intervention in school settings and to assess the preliminary effectiveness of adding a HL module to an obesity prevention intervention for adolescents.

Methods:

This study will take place in the Northeastern United States. Participants will be adolescents (13-16 years) attending school and recruitment will be done through flyers to parents and adolescents in participating classes or advisory groups at the school. A blinded randomized procedure will be used to allocate classrooms/advisory groups to intervention arms. The intervention includes two arms: (1) an experimental arm that will receive a HL module and three obesity prevention modules and (2) a comparison arm that will receive a vaping module and three obesity prevention modules. Participants will complete measures of their HL and obesogenic behaviors-related health knowledge, motivation, and behaviors at three time points (baseline, 1 month post-intervention, 3 months post-intervention). The primary outcomes will be measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy as measured by logistic and linear regressions and the calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.

Results:

The study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the digital intervention design is complete and ready for use, recruitment, data collection, and intervention implementation are scheduled to begin September 2022. Results are expected to be published in 2023.

Conclusions:

Study feasibility findings will inform changes to the intervention content and randomized controlled trial design. Study efficacy findings will inform sample size for the full scaled randomized controlled trial and preliminary utility of the intervention. Clinical Trial: ClinicalTrials.gov identifier: NCT04252677


 Citation

Please cite as:

Fleary SA

A Web-Based Intervention to Improve Health Literacy and Obesogenic Behaviors Among Adolescents: Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial

JMIR Res Protoc 2022;11(8):e40191

DOI: 10.2196/40191

PMID: 35972787

PMCID: 9428776

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