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基于互联网的生活方式干预:通过健康习惯预防2型糖尿病——随机对照试验的设计与6个月使用结果

Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

作者信息

Harjumaa Marja, Absetz Pilvikki, Ermes Miikka, Mattila Elina, Männikkö Reija, Tilles-Tirkkonen Tanja, Lintu Niina, Schwab Ursula, Umer Adil, Leppänen Juha, Pihlajamäki Jussi

机构信息

VTT Technical Research Centre of Finland Ltd, Espoo, Finland.

Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, Kuopio, Finland.

出版信息

JMIR Diabetes. 2020 Aug 11;5(3):e15219. doi: 10.2196/15219.

DOI:10.2196/15219
PMID:32779571
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7448183/
Abstract

BACKGROUND

Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes.

OBJECTIVE

The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT).

METHODS

The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users' activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes.

RESULTS

Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics.

CONCLUSIONS

Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.

摘要

背景

2型糖尿病可通过生活方式改变来预防,但仍缺乏可持续且可扩展的生活方式干预措施。基于习惯的方法为促使长期行为改变提供了契机。

目的

本研究旨在描述一种针对2型糖尿病高危人群的基于互联网的生活方式干预措施,以支持健康习惯的养成,并在随机对照试验(RCT)的前6个月探索其用户参与度。

方法

该应用程序提供一个在线商店,提供400多条由日常生活活动触发的简单且情境化的习惯养成行为建议。用户可以浏览、查看并选择这些建议;报告自己的执行情况;并反思自身活动。用户还可以获取提醒、其他用户活动的信息以及2型糖尿病预防信息。开展了一项非盲平行随机对照试验,以评估该应用程序与常规护理相比的有效性。根据参与者(年龄在18至70岁、居住在社区且2型糖尿病风险增加的成年人)的使用日志数据,报告试验前6个月的用户参与度。

结果

在网上招募的3271名参与者中,2909名符合参与随机对照试验的条件。参与者通过计算机随机化系统被随机分配到对照组(n = 971)、基于互联网的干预组(数字组,n = 967)和基于互联网且有面对面小组指导的干预组(F2F + 数字组,n = 971)。对照组参与者的平均年龄为55.0岁,数字组为55.2岁,F2F + 数字组为55.2岁。大多数参与者为女性,对照组为81.1%(787/971),数字组为78.3%(757/967),F2F + 数字组为80.7%(784/971)。在分配到数字组和F2F + 数字组的参与者中,99.53%(1929/1938)至少登录过一次该应用程序,98.55%(1901/1938)至少选择了一种习惯,95.13%(1835/1938)报告了至少一次习惯执行情况。该应用程序大多按周使用。在前6个月中,每周活跃用户数量从第1周的93.05%(1795/1929)变化到第26周的51.79%(999/1929)。每日使用活跃度没那么高。数字组和F2F + 数字组使用该应用程序的中位数天数分别为23.0天和24.5天,总时长分别为79.4分钟和85.1分钟。在前6个月共报告了1,089,555次习惯执行情况。在累积使用指标方面,各组之间的使用指标没有显著差异。

结论

结果表明,基于互联网的生活方式干预措施可以提供给包括居住在社区的中年和老年人在内的大群体,其中许多人在数字应用程序使用方面经验有限,且无需额外的用户培训。这种对使用行为的中期分析显示出相对良好的参与度,6个月时每周活跃用户的百分比保持在50%以上。然而,我们尚不清楚每周的参与度是否足以改变参与者的生活方式。

试验注册

ClinicalTrials.gov NCT03156478;https://clinicaltrials.gov/ct2/show/NCT03156478 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/be35d20584cf/diabetes_v5i3e15219_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/2fff360cec3e/diabetes_v5i3e15219_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/41814f0d6f75/diabetes_v5i3e15219_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/7d5fb3c119ed/diabetes_v5i3e15219_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/dee1cf4ec47e/diabetes_v5i3e15219_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/be35d20584cf/diabetes_v5i3e15219_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/2fff360cec3e/diabetes_v5i3e15219_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/41814f0d6f75/diabetes_v5i3e15219_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/7d5fb3c119ed/diabetes_v5i3e15219_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/dee1cf4ec47e/diabetes_v5i3e15219_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77a5/7448183/be35d20584cf/diabetes_v5i3e15219_fig5.jpg

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