Weaver R Glenn, Armstrong Bridget, Adams Elizabeth, Beets Michael, White James, Flory Kate, Wilson Dawn, Mclain Alex, Tennie Brianna
University of South Carolina.
University of South Carolina Arnold School of Public Health.
Res Sq. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1.
BackgroundThis study assessed initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain.MethodsThis pilot 2x2 factorial randomized control trial used a mixed methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV + PI) to mitigate accelerated summer body mass index (BMI) gain. Feasibility (i.e., recruitment capability, retention, compliance, treatment fidelity, acceptability) was examined using means, standard deviations, and percentages for relevant variables. Changes in BMI were estimated using intent-to-treat and post-hoc dose response analyses via multilevel mixed effects regressions.ResultsA total of 89 families participated, with 24 participants randomized to the PI group, 21 randomized to the SCV group, 23 randomized to the SCV + PI group, and 21 randomized to the control. Parents and children found the summer program acceptable but attendance at the summer program and engagement in the PI were low due to COVID-19 and lack of transportation. Intent-to-treat analyses showed no statistically significant difference between groups in summer BMI gain. Post-hoc dose response analyses showed that for each day (0 to 29) of summer programming children attended they gained - 0.009 (95CI= -0.018, -0.001) less in BMI z-score.ConclusionsEngagement in both the SCV and PI was not ideal and was likely due to COVID-19 and lack of transportation. Providing children with structured summer programming to mitigate accelerated summer BMI gain may be an effective strategy. Thus, a larger trial may be warranted, but more work is needed to ensure children attend the programming.Trial registration: The trial reported herein was prospectively registered at clinicaltrials.gov. Trial #:NCT04608188.
背景
本研究评估了为儿童提供免费暑期日间夏令营及家长干预措施以改善自我调节能力并减轻暑期体重指数(BMI)加速增长的初步可行性和疗效。
方法
这项试点2×2析因随机对照试验采用混合方法设计,以评估为儿童提供免费暑期日间夏令营(SCV)、家长干预措施(PI)以及这两种策略的组合(SCV + PI)对减轻暑期体重指数(BMI)加速增长的效果。通过计算相关变量的均值、标准差和百分比来检验可行性(即招募能力、留存率、依从性、治疗保真度、可接受性)。使用意向性分析和事后剂量反应分析,通过多级混合效应回归估计BMI的变化。
结果
共有89个家庭参与,其中24名参与者被随机分配到PI组,21名被随机分配到SCV组,23名被随机分配到SCV + PI组,21名被随机分配到对照组。家长和儿童认为暑期项目是可接受的,但由于新冠疫情和交通不便,暑期项目的出勤率和家长干预措施的参与度较低。意向性分析显示,各组之间暑期BMI增长没有统计学上的显著差异。事后剂量反应分析表明,儿童参加暑期项目的每一天(0至29天),其BMI z评分的增长减少了-0.009(95%置信区间=-0.018,-0.001)。
结论
参与SCV和PI的情况都不理想,可能是由于新冠疫情和交通不便。为儿童提供有组织的暑期项目以减轻暑期BMI加速增长可能是一种有效的策略。因此,可能需要进行更大规模的试验,但需要做更多工作来确保儿童参加该项目。
本文报告的试验已在clinicaltrials.gov上进行前瞻性注册。试验编号:NCT04608188。