School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.
Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW 2308, Australia.
Int J Environ Res Public Health. 2020 Sep 28;17(19):7115. doi: 10.3390/ijerph17197115.
Self-administered eHealth interventions provide a potential low-cost solution for reducing diabetes risk. The aim of this pilot randomised controlled trial (RCT) was to evaluate the feasibility, including recruitment, retention, preliminary efficacy (primary outcome) and acceptability (secondary outcome) of the "Body Balance Beyond" eHealth intervention in women with previous gestational diabetes mellitus (GDM). Women with overweight/obesity who had recent GDM (previous 24 months) were randomised into one of three groups: 1) high personalisation (access to "Body Balance Beyond" website, individual telehealth coaching via video call by a dietitian and exercise physiologist, and text message support); 2) low personalisation (website only); or 3) waitlist control. To evaluate preliminary efficacy, weight (kg), glycosylated hemoglobin, type A1C (HbA1c), cholesterol (total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL)), diet quality and moderate-vigorous physical activity were analysed at baseline and at 3 and 6 months using generalised linear mixed models. To investigate acceptability, process evaluation was conducted at 3 and 6 months. Of the 327 potential participants screened, 42 women (mean age 33.5 ± 4.0 years and BMI 32.4 ± 4.3 kg/m) were randomised, with 30 (71%) completing the study. Retention at 6 months was 80%, 54% and 79% for high personalisation, low personalisation and waitlist control, respectively (reasons: personal/work commitments, = 4; started weight-loss diet, = 1; pregnant, = 1; resources not useful, = 1; and not contactable, = 5). No significant group-by-time interactions were observed for preliminary efficacy outcomes, with the exception of HDL cholesterol, where a difference favoured the low personalisation group relative to the control ( = 0.028). The majority (91%) of women accessed the website in the first 3 months and 57% from 4-6 months. The website provided useful information for 95% and 92% of women at 3 and 6 months, respectively, although only a third of women found it motivating (30% and 25% at 3 and 6 months, respectively). Most women agreed that the telehealth coaching increased their confidence for improving diet (85%) and physical activity (92%) behaviours, although fewer women regarded the text messages as positive (22% and 31% for improving diet and physical activity, respectively). The majority of women (82% at 3 months and 87% at 6 months) in the high personalisation group would recommend the program to other women with GDM. Recruiting and retaining women with a recent diagnosis of GDM is challenging. The "Body Balance Beyond" website combined with telehealth coaching via video call is largely acceptable and useful for women with recent GDM. Further analysis of the effect on diabetes risk reduction in a larger study is needed.
自我管理的电子健康干预措施为降低糖尿病风险提供了一种潜在的低成本解决方案。本试验性随机对照试验（RCT）的目的是评估“Body Balance Beyond”电子健康干预措施在有既往妊娠糖尿病（GDM）的女性中的可行性，包括招募、保留、初步疗效（主要结局）和可接受性（次要结局）。超重/肥胖且近期有 GDM（过去 24 个月）的女性被随机分为三组：1）高个性化（访问“Body Balance Beyond”网站、营养师和运动生理学家通过视频电话进行个人远程健康指导以及短信支持）；2）低个性化（仅网站）；或 3）候补名单对照。为了评估初步疗效，在基线和 3 个月和 6 个月时使用广义线性混合模型分析体重（kg）、糖化血红蛋白、A1C 型（HbA1c）、胆固醇（总胆固醇、低密度脂蛋白（LDL）和高密度脂蛋白（HDL））、饮食质量和中等强度至剧烈的体力活动。为了调查可接受性，在 3 个月和 6 个月时进行了过程评估。在 327 名潜在参与者中，有 42 名女性（平均年龄 33.5 ± 4.0 岁，BMI 为 32.4 ± 4.3kg/m）被随机分配，其中 30 名（71%）完成了研究。6 个月时的保留率分别为高个性化组 80%、低个性化组 54%和候补名单对照组 79%（原因：个人/工作承诺、=4；开始减肥饮食、=1；怀孕、=1；资源不有用、=1；无法联系、=5）。除了 HDL 胆固醇外，初步疗效结果未观察到组间时间交互作用，在低个性化组相对于对照组有差异（=0.028）。大多数女性（91%）在头 3 个月内访问了该网站，57%的女性在第 4-6 个月访问了该网站。该网站在头 3 个月和 6 个月时分别为 95%和 92%的女性提供了有用的信息，但只有三分之一的女性认为它具有激励作用（头 3 个月和 6 个月分别为 30%和 25%）。大多数女性（头 3 个月为 85%，6 个月为 87%）认为远程健康指导增加了她们改善饮食（85%）和体育活动（92%）行为的信心，尽管只有少数女性认为短信是积极的（改善饮食和体育活动的短信分别为 22%和 31%）。高个性化组中的大多数女性（头 3 个月为 82%，6 个月为 87%）会向其他有 GDM 的女性推荐该计划。招募和保留近期诊断为 GDM 的女性具有挑战性。“Body Balance Beyond”网站结合视频电话远程健康指导在近期有 GDM 的女性中基本是可以接受和有用的。需要进一步分析该方案在更大规模研究中对降低糖尿病风险的影响。
