数字健康干预降低心血管风险：一项随机临床试验。

A Digital Health Intervention to Lower Cardiovascular Risk: A Randomized Clinical Trial.

机构信息

Department of Medicine, McMaster University, Hamilton, Ontario, Canada2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada3Population Health Research Institute, McMaster University and Hamilton Health Scie.

Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada3Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada4Department of Psychiatry and Behavioral.

出版信息

JAMA Cardiol. 2016 Aug 1;1(5):601-6. doi: 10.1001/jamacardio.2016.1035.

DOI:10.1001/jamacardio.2016.1035

PMID:27438754

Abstract

IMPORTANCE

South Asian individuals have a high burden of premature myocardial infarction (MI).

OBJECTIVES

To test whether a digital health intervention (DHI) designed to change diet and physical activity improves MI risk among a South Asian population.

DESIGN, SETTING, AND PARTICIPANTS: This single-blind, community-based, randomized clinical trial with 1-year follow-up was performed among South Asian men and women 30 years or older and living in Ontario and British Columbia who were free of cardiovascular disease. Data analysis was by intention to treat. Data were collected from June 3, 2012, to October 27, 2013. Final follow-up was completed on December 2, 2014, and data were analyzed from April 2, 2015, to February 29, 2016.

INTERVENTIONS

Participants were randomized 1:1 to the DHI or control condition. The goal-setting DHI used emails or text messages and focused on improving diet and physical activity that was tailored to the participant's self-reported stage of change.

MAIN OUTCOMES AND MEASURES

The change in an MI risk score from baseline to 1 year was the primary outcome. Secondary outcomes included the change in each objectively measured component of the MI risk score (ie, blood pressure, waist to hip ratio, hemoglobin A1c level, and the ratio of apolipoprotein B to apolipoprotein A). Genetic risk for MI was determined by counting the 9p21 risk alleles; results were provided to each participant at baseline.

RESULTS

A total of 343 South Asian men and women (178 men [51.9%]; mean [SD] age, 50.6 [11.4] years) who were free of cardiovascular disease were randomized to the control condition (n = 174) or the DHI (n = 169). The mean (SD) MI risk score was 13.3 (6.6) at baseline. No significant difference was found in the change in MI score after 1 year between the DHI and control groups (-0.27; 95% CI, -1.12 to 0.58; P = .53) after adjusting for baseline scores, and no difference was found in the fully adjusted model (-0.39; 95% CI, -1.24 to 0.45; P = .36). No association between knowledge of the genetic risk status at baseline and the change in MI risk score was found (0.19; 95% CI, -0.40 to 0.78; P = .53).

CONCLUSIONS AND RELEVANCE

Among South Asian individuals, a DHI was not associated with a reduction in MI risk score after 12 months and was not influenced by knowledge of genetic risk status.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01841398.

摘要

重要性

南亚个体有过早心肌梗死（MI）的高负担。

目的

检验一种旨在改变饮食和体力活动的数字健康干预（DHI）是否能改善南亚人群的 MI 风险。

设计、地点和参与者：这是一项单盲、基于社区、随机临床试验，随访期为 1 年，纳入了 30 岁或以上、居住在安大略省和不列颠哥伦比亚省且无心血管疾病的南亚男性和女性。数据分析采用意向治疗。数据于 2012 年 6 月 3 日至 2013 年 10 月 27 日采集。最终随访于 2014 年 12 月 2 日完成，数据分析于 2015 年 4 月 2 日至 2016 年 2 月 29 日进行。

干预措施

参与者按 1:1 随机分配到 DHI 或对照组。目标设定的 DHI 使用电子邮件或短信，并侧重于根据参与者自我报告的改变阶段来改善饮食和体力活动。

主要结局和测量指标

从基线到 1 年的 MI 风险评分变化是主要结局。次要结局包括每个 MI 风险评分的客观测量成分的变化（即血压、腰臀比、糖化血红蛋白水平和载脂蛋白 B 与载脂蛋白 A 的比值）。MI 的遗传风险通过计算 9p21 风险等位基因来确定；结果在基线时提供给每位参与者。

结果

共有 343 名南亚男性和女性（178 名男性[51.9%]；平均[SD]年龄为 50.6[11.4]岁），无心血管疾病，被随机分配至对照组（n=174）或 DHI 组（n=169）。基线时 MI 风险评分的平均值（SD）为 13.3（6.6）。调整基线评分后，DHI 组和对照组在 1 年后的 MI 评分变化无显著差异（-0.27；95%CI，-1.12 至 0.58；P=0.53），完全调整模型中也无差异（-0.39；95%CI，-1.24 至 0.45；P=0.36）。基线时遗传风险状况的知识与 MI 风险评分的变化之间也没有关联（0.19；95%CI，-0.40 至 0.78；P=0.53）。