University of Nottingham, School of Health Sciences, Nottingham, UK.
University of Nottingham, School of Medicine, Nottingham, UK.
BMC Public Health. 2019 Apr 3;19(1):371. doi: 10.1186/s12889-019-6697-1.
Physical activity and self-monitoring are important for children with type 1 diabetes mellitus (T1DM) but it is unclear whether interventions delivered online are feasible, acceptable to patients and efficacious. The aim was to assess the feasibility and acceptability of an internet-based physical activity and self-monitoring programme for children with T1DM, and of a randomised controlled trial (RCT) to evaluate efficacy.
A total of 49 children aged 9-12 with T1DM were randomly assigned to usual care only or to an interactive intervention group combining a website (STAK-D) and a PolarActive activity watch (PAW; Polar Electro (UK) Ltd.), alongside usual care. Participants completed self-report measures on their health, self-efficacy and physical activity at baseline (T0), eight weeks (T1) and six months (T2). They also wore a PAW to measure physical activity for one week at the end of T0, T1 and T2. Intervention participants were interviewed about their experiences at T2. Explanatory variables were examined using multi-level modelling and examination of change scores, 95% confidence intervals and p-values with alpha set at 0.95. Descriptive analysis was undertaken of the 'end-of-study questionnaire'. Qualitative analysis followed a framework approach.
Completion rates for all self-report items and objective physical activity data were above 85% for the majority of measures. HbA1c data was obtained for 100% of participants, although complete clinical data was available for 63.3% to 63.5% of participants at each data collection time-point. Recruitment and data collection processes were reported to be acceptable to participants and healthcare professionals. Self-reported sedentary behaviour (-2.28, p=0.04, 95% CI=-4.40, -0.16; p = 0.04; d = 0.72) and parent-reported physical health of the child (6.15, p=0.01, 95%CI=1.75, 10.55; p = 0.01; d = 0.75) improved at eight weeks in the intervention group.
The trial design was feasible and acceptable to participants and healthcare providers. Intervention engagement was low and technical challenges were evident in both online and activity watch elements, although enjoyment was high among users. Reported outcome improvements were observed at 8 weeks but were not sustained.
ISRCTN 48994721 (prospectively registered). Date of registration: 28.09.2016.
对于 1 型糖尿病(T1DM)患儿而言,身体活动和自我监测非常重要,但目前尚不清楚在线干预是否可行、患者是否接受以及是否有效。本研究旨在评估一种基于互联网的 T1DM 患儿身体活动和自我监测计划的可行性和可接受性,并评估一项随机对照试验(RCT)的疗效。
共有 49 名年龄在 9-12 岁的 T1DM 患儿被随机分配至仅接受常规护理组或接受互动干预组(结合 STAK-D 网站和 PolarActive 活动监测器[PAW],外加常规护理)。参与者在基线(T0)、8 周(T1)和 6 个月(T2)时完成健康、自我效能和身体活动的自我报告测量。在 T0、T1 和 T2 结束时,他们还佩戴了 PAW 来测量一周的身体活动。干预组参与者在 T2 时接受了关于他们体验的访谈。使用多水平模型和变化分数的 95%置信区间和 p 值(alpha 值设定为 0.95)来检查解释变量。对“研究结束问卷”进行了描述性分析。定性分析遵循框架方法。
对于大多数测量指标,大多数参与者的自我报告项目和客观身体活动数据的完成率均高于 85%。虽然在每个数据收集时间点都可以获得 100%的参与者的 HbA1c 数据,但只有 63.3%至 63.5%的参与者可获得完整的临床数据。参与者和医疗保健专业人员报告称,招募和数据收集过程是可以接受的。自我报告的久坐行为(-2.28,p=0.04,95%CI=-4.40,-0.16;p=0.04;d=0.72)和父母报告的儿童身体健康状况(6.15,p=0.01,95%CI=1.75,10.55;p=0.01;d=0.75)在干预组中均在 8 周时得到改善。
试验设计对参与者和医疗保健提供者来说是可行且可接受的。干预参与率较低,在线和活动监测器元素均存在技术挑战,但用户的满意度很高。在 8 周时观察到报告的结果改善,但并未持续。
ISRCTN 48994721(前瞻性注册)。注册日期:2016 年 9 月 28 日。