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基于智能手机的生活方式指导应用对代谢异常的社区居民的影响:随机对照试验。

Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.

机构信息

Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.

Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.

出版信息

J Med Internet Res. 2020 Oct 9;22(10):e17435. doi: 10.2196/17435.

Abstract

BACKGROUND

Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.

OBJECTIVE

We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.

METHODS

In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.

RESULTS

Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).

CONCLUSIONS

Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.

摘要

背景

代谢紊乱是心血管疾病的既定前兆,但通过持续的生活方式改变,这些疾病是可以预防的。

目的

我们评估了一款基于智能手机的体重管理应用程序在社区环境中对处于高危状态但尚未被诊断为代谢综合征或接受药物治疗的成年人代谢参数的影响。

方法

在这项 3 臂平行组、单盲、随机对照试验中,我们招募了年龄在 30 至 59 岁之间的参与者,他们至少有 3 项符合第三次国家胆固醇教育计划专家小组报告(腹部肥胖、高血压、高甘油三酯、低高密度脂蛋白胆固醇和高空腹血糖)定义的条件。参与者按 1:1:1 的比例通过区组随机分配到非使用者组(对照组)、基于应用程序的饮食和运动自我记录组(仅应用程序组)或基于应用程序的自我记录和由专业营养师和运动协调员提供个性化指导组(应用程序加个性化指导组)。在基线、第 6 周、第 12 周和第 24 周进行评估。主要结局是收缩压的变化(与基线和随访评估相比)。次要结局是舒张压、体重、体脂肪量、腰围、稳态模型评估的胰岛素抵抗、甘油三酯水平和高密度脂蛋白胆固醇水平的变化,与基线和随访评估相比。分析采用意向治疗。

结果

在 2017 年 10 月 28 日至 2018 年 5 月 28 日期间,有 160 名参与者参加了基线筛查检查。符合入选标准的 129 名参与者(80.6%)被分配到对照组(n=41)、仅应用程序组(n=45)或应用程序加个性化指导组(n=43)。在每组中,收缩压从基线呈下降趋势(对照组:平均-10.95,SD 2.09mmHg;仅应用程序组:平均-7.29,SD 1.83mmHg;应用程序加个性化指导组:平均-7.19,SD 1.66mmHg),但组间无显著差异(仅应用程序组:P=.19;应用程序加个性化指导组:P=.16)。相反,应用程序加个性化指导组的体重减轻更多(对照组:平均-0.12,SD 0.30kg;仅应用程序组:平均-0.35,SD 0.36kg,P=.67;应用程序加个性化指导组:平均-0.96,SD 0.37kg;P=.08),特别是体脂肪量的减少(对照组:平均-0.13,SD 0.34kg;仅应用程序组:平均-0.64,SD 0.38kg,P=.22;应用程序加个性化指导组:平均-0.79,SD 0.38kg;P=.08)。

结论

同时进行饮食和运动自我记录以及持续的生活方式改变指导对降低收缩压无效,但对减肥和减少体脂肪量有效。这些结果证明了在初级预防的背景下,在更大范围内实施类似护理模式的未来研究是合理的。

试验注册

ClinicalTrials.gov NCT03300271;http://clinicaltrials.gov/ct2/show/NCT03300271。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6332/7584978/20dd08b73eaf/jmir_v22i10e17435_fig1.jpg

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