Fleary Sasha A
Department of Community Health and Social Sciences, Graduate School of Public Health and Health Policy, City University of New York, New York, NY, United States.
JMIR Res Protoc. 2022 Aug 16;11(8):e40191. doi: 10.2196/40191.
Predictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents' obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents' obesity status. However, HL has not been included in obesity interventions targeting adolescents.
This study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents.
This web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior-related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the 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 calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.
This study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023.
This study's feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study's efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention.
ClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40191.
预测性理论模型表明，健康知识与动机和行为技能共同作用，以影响青少年的致胖行为。然而，现有的大多数青少年干预措施都是孤立地针对这些变量。此外，健康素养（HL）作为健康知识的先导，对于将健康知识转化为行为是必要的，并且与青少年的肥胖状况呈负相关。然而，HL尚未被纳入针对青少年的肥胖干预措施中。
本研究旨在试点在学校环境中开展一项双臂基于网络的肥胖预防干预措施的可行性，并评估在青少年肥胖预防干预措施中增加一个HL模块的初步效果。
这项基于网络的试点可行性研究将在美国东北部进行。参与者将是在校青少年（13 - 16岁），招募将通过向学校参与班级或咨询小组中的家长和青少年发放传单来进行。干预措施包括两个臂：一个试验臂将接受一个HL模块和3个肥胖预防模块，一个对照臂将接受一个电子烟模块和3个肥胖预防模块。将使用盲法随机程序将教室和咨询小组分配到试验臂和对照臂。干预将完全基于网络。参与者将在3个时间点（基线、干预后1个月和干预后3个月）通过基于网络的调查完成其HL以及与致胖行为相关的健康知识、动机和行为的测量。主要结局将是研究可行性的测量指标（招募率、留存率、完成率和治疗保真率）。次要结局将是初步疗效，通过逻辑回归和线性回归以及效应量计算来衡量。将对每个时间点的所有测量指标进行描述性统计。
本研究于2020年8月获得纽约城市大学机构审查委员会的批准。截至2022年6月，基于网络的干预设计已完成并准备好使用。招募、数据收集和干预实施计划于2022年9月开始。这些结果预计于2023年发表。
本研究的可行性结果将为干预内容和随机对照试验设计的改变提供依据。本研究的疗效结果将为大规模随机对照试验的样本量以及干预的初步效用提供依据。
ClinicalTrials.gov NCT04252677；https://clinicaltrials.gov/ct2/show/NCT04252677。
国际注册报告标识符（IRRID）：PRR1 - 10.2196/40191。
