一项在线干预措施（STAK-D）促进1型糖尿病儿童身体活动的可行性：一项随机对照试验方案

Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial.

作者信息

Blake Holly, Quirk Helen, Leighton Paul, Randell Tabitha, Greening James, Guo Boliang, Glazebrook Cris

机构信息

University of Nottingham School of Health Sciences, A Floor, Queen's Medical Centre, Nottingham, NG7 2HA, UK.

University of Nottingham School of Medicine, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.

出版信息

Trials. 2016 Dec 8;17(1):583. doi: 10.1186/s13063-016-1719-0.

DOI:10.1186/s13063-016-1719-0

PMID:27931254

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5146845/

Abstract

BACKGROUND

Regular physical activity has important health benefits for children with type 1 diabetes mellitus (T1DM), yet children and their parents face barriers to participation such as lack of self-efficacy or concerns around hypoglycaemia. Multimedia interventions are useful for educating children about their health and demonstrate potential to improve children's health-related self-efficacy, but few paediatric clinics offer web-based resources as part of routine care. The Steps to Active Kids with Diabetes (STAK-D) programme is an online intervention grounded in psychological theory (social cognitive theory) and informed by extensive preliminary research. The aim of the programme is to encourage and support safe engagement with physical activity for children with T1DM. The aim of this research is to explore the feasibility of delivering the STAK-D programme to children aged 9-12 years with T1DM, and to assess the feasibility of further research to demonstrate its clinical and cost-effectiveness.

METHODS

Up to 50 children aged 9-12 years with T1DM and their parents will be recruited from two paediatric diabetes clinics in the UK. Child-parent dyads randomised to the intervention group will have access to the intervention website (STAK-D) and a wrist-worn activity monitor for 6 months. The feasibility of intervention and further research will be assessed by rate of recruitment, adherence, retention, data completion and adverse events. Qualitative interviews will be undertaken with a subsample of children and parents (up to 25 dyads) and health care professionals (up to 10). Health outcomes and the feasibility of outcome measurement tools will be assessed. These include self-efficacy (CSAPPA), objective physical activity, self-reported physical activity (PAQ), fear of hypoglycaemia (CHFS; PHFS), glycaemic control (HbA1c), insulin dose, Body Mass Index (BMI), health-related quality of life (CHU9D; CHQ-PF28), health service use and patient-clinician communication. Assessments will be taken at baseline (T0), 8 weeks (T1) and at 6-month follow-up (T2).

DISCUSSION

The goal of this feasibility trial is to assess the delivery of STAK-D to promote physical activity among children with T1DM, and to assess the potential for further, definitive research to demonstrate its effectiveness. Results will provide the information necessary to design a larger randomised controlled trial and maximise the recruitment rate, intervention delivery and trial retention.

TRIAL REGISTRATION

ISRCTN, ISRCTN48994721 . Registered on 28 October 2016.

摘要

背景

规律的体育活动对1型糖尿病（T1DM）患儿具有重要的健康益处，但患儿及其父母在参与体育活动方面面临障碍，如缺乏自我效能感或对低血糖的担忧。多媒体干预有助于对儿童进行健康知识教育，并显示出提高儿童健康相关自我效能感的潜力，但很少有儿科诊所将基于网络的资源作为常规护理的一部分提供。糖尿病患儿积极运动步骤（STAK-D）计划是一项基于心理学理论（社会认知理论）并经过大量初步研究的在线干预措施。该计划的目的是鼓励和支持T1DM患儿安全地参与体育活动。本研究的目的是探讨将STAK-D计划提供给9至12岁T1DM患儿的可行性，并评估进一步研究以证明其临床和成本效益的可行性。

方法

将从英国的两家儿科糖尿病诊所招募多达50名9至12岁的T1DM患儿及其父母。随机分配到干预组的儿童-父母二元组将可以访问干预网站（STAK-D）和佩戴6个月的腕部活动监测器。将通过招募率、依从性、保留率、数据完成率和不良事件来评估干预和进一步研究的可行性。将对一部分儿童和父母（最多25个二元组）以及医疗保健专业人员（最多10名）进行定性访谈。将评估健康结果和结果测量工具的可行性。这些指标包括自我效能感（CSAPPA）、客观体育活动、自我报告的体育活动（PAQ）、对低血糖的恐惧（CHFS；PHFS）、血糖控制（糖化血红蛋白）、胰岛素剂量、体重指数（BMI）、健康相关生活质量（CHU9D；CHQ-PF28）、医疗服务利用情况以及医患沟通。将在基线（T0）、8周（T1）和6个月随访（T2）时进行评估。