支持超重和肥胖儿童的家庭过上健康的生活方式：Fitline 集群随机对照儿科实践基础试验的设计和原理。
Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial.
机构信息
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.
Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.
出版信息
Contemp Clin Trials. 2021 May;104:106348. doi: 10.1016/j.cct.2021.106348. Epub 2021 Mar 8.
BACKGROUND
Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs.
PURPOSE
To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook).
METHODS
Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined.
CONCLUSION
This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice.
TRIAL REGISTRATION
The ClinicalTrials.gov registration number is NCT03143660.
背景
超过三分之一的超重或肥胖的青春期前儿童。儿科学会（AAP）建议儿科医生帮助家庭改变饮食和活动方式，以改善体重指数（BMI）。然而，由于时间有限，转介来源有限，以及家庭负担难以获得面对面的体重管理项目，实施起来具有挑战性。
目的
描述一项由美国国立心肺血液研究所赞助的基于儿科的群组随机对照试验的设计，该试验评估了 Fitline 儿科实践转介计划的有效性，以降低超重或肥胖儿童的 BMI，并改善饮食和体育活动。将简短的提供者干预加转介与以下两种情况进行比较：（1）八次由营养师提供的每周营养咨询电话和工作手册，以帮助家庭进行 AAP 推荐的生活方式改变（Fitline-Coaching），与（2）八次邮寄工作手册但没有咨询（Fitline-Workbook）。
方法
20 个实践进行配对随机分组到两种条件之一；正在招募 494 名父母及其年龄在 8-12 岁、BMI 大于等于第 85 百分位数的孩子。主要结果是儿童 BMI；次要结果是儿童在基线和 6 个月及 12 个月时的饮食和身体活动。还将检查两种干预措施的成本效益。
结论
这是第一项随机对照试验，研究使用集中电话咨询服务来支持超重和肥胖儿童的家庭进行 AAP 推荐的生活方式改变。如果有效，Fitline 计划将为广泛传播提供创新模式，为儿科实践中的体重管理护理制定新标准。
试验注册
ClinicalTrials.gov 注册号为 NCT03143660。
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