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.
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.
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基于网络的干预措施可提高青少年的健康素养并改善肥胖行为： 并行随机对照试验的随机试点可行性研究方案》（Protocol of a Randomized Pilot Feasibility Study for a Parallel Randomized Controlled Trial）。
DOI：
10.2196/40191
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发表时间：
2022-08-16
影响因子：
1.7
通讯作者：
Fleary, Sasha A
中科院分区：
文献类型：
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作者：
Fleary, Sasha A
预测理论模型表明，健康知识与动机和行为技能相结合，可以影响青少年的肥胖行为。然而，大多数现有的青少年干预措施都是孤立地针对这些变量的。此外，健康素养（HL）作为健康知识的前身，是将健康知识转化为行为的必要条件，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。本研究旨在在学校环境中试点基于 2 臂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添加 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），招募将通过传单发送给学校参与班级或咨询小组的家长和青少年。该干预措施包括 2 个组：一个实验组将接受 HL 模块和 3 个肥胖预防模块，另一个对照组将接受电子烟模块和 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给实验组和比较组。干预将完全基于网络。参与者将通过网络调查在 3 个时间点（基线、干预后 1 个月和干预后 3 个月）完成对 HL 和肥胖行为相关健康知识、动机和行为的测量。主要结果将是研究可行性的衡量（招募、保留、完成和治疗保真率）。次要结果将是初步疗效，通过逻辑回归和线性回归以及效应大小的计算来衡量。将计算每个时间点的所有测量的描述性统计数据。这项研究于 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可供使用。招募、数据收集和干预实施计划于 2022 年 9 月开始。这些结果预计将于 2023 年发布。这项研究的可行性研究结果将为干预内容和随机对照试验设计的变化提供信息。该研究的功效结果将为全面随机对照试验的样本量和干预措施的初步效用提供信息。 ClinicalTrials.gov NCT04252677； https://clinicaltrials.gov/ct2/show/NCT04252677 PRR1-10.2196/40191
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 PRR1-10.2196/40191