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临床试验/NCT03215472
NCT03215472已完成不适用

DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women at Risk for Cardiovascular Disease

Duke University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Adherence to the DASH Diet

研究概览

简要总结

This study will test whether a digital health intervention (DASH Cloud) using smartphones can improve diet quality among women at risk for cardiovascular disease. The DASH (Dietary Approaches to Stop Hypertension) Diet has been proven to lower blood pressure, yet dissemination efforts remain poor. This study aims to use technology to improve adherence to DASH.

详细描述

Specifically, this study aims to

  1. To test the feasibility of the DASH Cloud intervention compared to education control among women with prehypertension and hypertension via a 3-month randomized controlled trial.
  2. To evaluate the preliminary efficacy of the DASH Cloud intervention relative to education control on blood pressure, weight and medication adherence at 3 months.

This study will enroll 50 adult women aged 21-70 with pre-hypertension or hypertension in a 3-month randomized controlled trial to test the initial feasibility of DASH Cloud. Women will be randomized to either the DASH Cloud intervention or DASH Light and followed up 3 months post randomization. The investigators will recruit participants from the Durham, NC area.

Women randomized to the DASH Cloud intervention will be asked to track their diet daily using a smartphone diet tracking app. Based on the foods/beverages entered, the intervention will send daily or weekly text messages with feedback about DASH adherence and information videos about how to follow DASH. Women randomized to DASH Light will also be asked to track their diet using the smartphone diet tracking app and will receive basic informational materials about DASH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages 21-70 years; BMI >18.5 kg/m2
  • on antihypertensive medication or systolic blood pressure 120-159 mmHg and/or diastolic blood pressure of 80-99
  • current use of a smartphone and willingness to be texted daily or weekly
  • an email account; spoken and written English fluency.

排除标准

  • CVD event in prior 6 months
  • active malignancy; active psychosis or recent psychiatric institutionalization
  • current pregnancy or lactation
  • current participation in a similar trial.

结局指标

主要结局

Adherence to the DASH Diet

时间窗: 3 months

Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.

次要结局

  • Change in Blood Pressure(Baseline, 3 months)
  • Change in Weight(Baseline, 3 months)
  • Engagement(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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