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

Duke University

Status: Completed

Conditions: Hypertension; Women's Health; Digital Health; Cardiovascular Diseases; Diet Modification

Treatments: Other: DASH Cloud; Other: Nutritionix Track app

Study type: Interventional

Funder types: Other

Identifiers

NCT03215472

Pro00081972

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

DASH Cloud intervention

Experimental group

Description:

In group 1, participants will be instructed to input their dietary intake daily for three months using the Nutritionix app. A participant's data will automatically be uploaded from the Nutritionix app via the API that links the device with DASH Cloud. DASH Cloud will run an algorithm and send daily or weekly feedback text messages reflecting DASH adherence. The intervention components include tailored feedback texts, and behavioral skills training videos.

Treatment:

Other: DASH Cloud

Dash Light

Experimental group

Description:

Group 2 participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.

Treatment:

Other: Nutritionix Track app