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

Not Applicable

Completed

• Conditions: Hypertension; Diet Modification; Women's Health; Digital Health; Cardiovascular Diseases
• Interventions: Other: DASH Cloud; Other: Nutritionix Track app

• Registration Number: NCT03215472
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-07-21
• Status Verified: 2018-03
• Primary Completion: 2018-03-12
• Study Completion: 2018-03-12
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DASH Cloud intervention	DASH Cloud	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.
Dash Light	Nutritionix Track app	Group 2 participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.

Primary Outcome Measures

Name	Time	Method
Adherence to the DASH Diet	3 months	Dietary intake data will be collected using NCI's Automated Self-Administered 24-hour Recall tool.

Secondary Outcome Measures

Name	Time	Method
Change in Blood Pressure	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.
Engagement	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.
Change in Weight	Baseline, 3 months	Weight will be collected in kilograms at baseline and 3 months using a calibrated digital scale.

Trial Locations

Locations (1)

The Sarah W. Stedman Nutrition and Metabolism Center; 🇺🇸 Durham, North Carolina, United States