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Completed

NCT Number: NCT03215472

DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women

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.

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Key information

Conditions

Diet Modification Cardiovascular Diseases Digital Health Hypertension Vascular Diseases Women's Health

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sarah W. Stedman Nutrition and Metabolism Center

Durham, North Carolina, 27708, United States

About this study

Specifically, this study aims to

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

DASH Cloud

Other

With DASH Cloud, the investigators will ask participants to track their diet daily using a commercial diet tracking app. The investigators will retrieve the diet data on our DASH Cloud platform and provide tailored feedback about a participant's DASH adherence via fully automated daily or weekly text messages. These feedback messages will describe both an individual's absolute performance and change over time. The investigators also include theory-driven tailored content that reinforces successes, offers motivational strategies, and offers short behavior change tips.

Nutritionix Track app

Other

DASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.

Other names: DASH Light

Primary outcomes

  1. Adherence to the DASH Diet

    Time frame: 3 months

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

Secondary outcomes

  1. Change in Blood Pressure

    Time frame: Baseline, 3 months

    Blood pressure will be measured at baseline and 3 months in the upper arm in triplicate at 1-minute intervals. Measurements will be obtained using the validated Omron HEM-907XL blood pressure monitor.

  2. Change in Weight

    Time frame: Baseline, 3 months

    Weight will be collected in kilograms at baseline and 3 months using a calibrated digital scale.

  3. Engagement

    Time frame: 3 months

    Utilization of intervention component (daily diet tracking using Nutritionix app) at 3 months. This will be measured by the proportion of participants completing daily dietary self-monitoring.

  4. Engagement

    Time frame: 3 months

    Utilization of intervention component (review of skills training videos) at 3 months. This will be measured by the number of clicks to skills training via video tracking software.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2017
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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