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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215472
• Other study ID #: Pro00081972
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: March 12, 2018

Study information

• Verified date: March 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	The Sarah W. Stedman Nutrition and Metabolism Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the DASH Diet	Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.	3 months
Secondary	Change in Blood Pressure	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.	Baseline, 3 months
Secondary	Change in Weight	Weight will be collected in kilograms at baseline and 3 months using a calibrated digital scale.	Baseline, 3 months
Secondary	Engagement	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.	3 months
Secondary	Engagement	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.	3 months