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满足肥胖儿童未得到满足的社会需求:一项试点随机对照试验。

Addressing unmet social needs of children with obesity: a pilot randomized controlled trial.

作者信息

Wahi Gita, Marjerrison Stacey, Gill Simrat, Krasevich Kimberley, Morrison Katherine M, Thabane Lehana

机构信息

Department of Pediatrics, McMaster University, Hamilton, ON, Canada.

McMaster Children's Hospital, Hamilton, ON, Canada.

出版信息

Pilot Feasibility Stud. 2024 Nov 14;10(1):141. doi: 10.1186/s40814-024-01570-9.

Abstract

BACKGROUND

Childhood obesity is an ongoing public health crisis, and recent clinical practice guidelines identify addressing the role of social inequities in the disparity of health among children with obesity as an area to address. This study aimed to assess the feasibility of a community navigation intervention in a pediatric weight management clinic.

METHODS

A single-center pilot randomized controlled trial (RCT) recruiting families from a tertiary hospital pediatric weight management program to evaluate the feasibility of a community navigation intervention. The primary feasibility outcomes were recruitment rates (goal to recruit 80% of the sample in 6 months), uptake of the intervention (goal > 80% of participants in the intervention group to have a visit with the navigator), and acceptability (goal > 90% of families in the intervention group complete all follow-up).

RESULTS

Eighty participants completed the social needs screening, and 42 (52.5%) participants screened positive for an unmet social need. In the first 6 months of recruitment, 18 participants were recruited out of a goal of 40 participants (the recruitment rate was 45% vs. the goal of 80% in 6 months), and complete recruitment was achieved in 12 months. Of the 21 participants randomized to the intervention arm, 20 completed the intervention (uptake of intervention was 95% vs. goal 80%). Ten participants in the intervention arm completed all four planned follow-up study visits (the acceptability of follow-up was 48% vs. the goal of 90%).

CONCLUSION

We completed a pilot RCT of implementing a community navigator program in a pediatric weight management program. We found feasibility in the intervention's uptake but limited feasibility in recruiting participants and the acceptability of the follow-up.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT04711707, https://clinicaltrials.gov/ct2/show/NCT04711707.

摘要

背景

儿童肥胖是一个持续存在的公共卫生危机,最近的临床实践指南将解决社会不平等在肥胖儿童健康差异中的作用确定为一个需要解决的领域。本研究旨在评估社区导航干预在儿科体重管理诊所的可行性。

方法

一项单中心试点随机对照试验(RCT),从一家三级医院的儿科体重管理项目中招募家庭,以评估社区导航干预的可行性。主要可行性结果包括招募率(目标是在6个月内招募80%的样本)、干预措施的接受率(目标是干预组中>80%的参与者与导航员进行一次访问)和可接受性(目标是干预组中>90%的家庭完成所有随访)。

结果

80名参与者完成了社会需求筛查,42名(52.5%)参与者筛查出存在未满足的社会需求。在招募的前6个月,目标是招募40名参与者,实际招募了18名(招募率为45%,而6个月的目标是80%),并在12个月内完成了全部招募。在随机分配到干预组的21名参与者中,20名完成了干预(干预接受率为95%,而目标是80%)。干预组中有10名参与者完成了所有四次计划的随访研究访问(随访的可接受性为48%,而目标是90%)。

结论

我们在儿科体重管理项目中完成了一项实施社区导航员项目的试点RCT。我们发现干预措施的接受方面具有可行性,但在招募参与者和随访的可接受性方面可行性有限。

试验注册

Clinicaltrials.gov,NCT04711707,https://clinicaltrials.gov/ct2/show/NCT04711707

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a593/11562815/1bd981556ac0/40814_2024_1570_Fig1_HTML.jpg

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