Testing the Feasibility of the DASH Cloud Intervention Using Amazon Alexa

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03455946
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

The DASH diet is a proven behavioral strategy to reduce blood pressure, however, national adherence rates are poor. Using digital health tools may help to improve adoption of the DASH diet. Digital health approaches capitalize on the ubiquitous utilization of mobile technologies and have broad dissemination potential. There have been few efforts to test a DASH intervention via digital, and none using voice-activated technologies (e.g, Amazon Alexa). This proposal will enroll up to 20 participants to leverage a commercial diet tracking application, an existing intervention technology platform and the Amazon Echo Dot to test the feasibility of using DASH Cloud, a digital health intervention, with the Amazon Alexa personal assistant.

Condition or Disease	Intervention/Treatment	Phase
Behavior, Health; Diet Modification	Behavioral: DASH cloud with Alexa	N/A

Detailed Description

Digital health approaches are promising intervention channels for improving DASH diet adherence. Almost all Americans own a mobile phone and 97% of mobile phone owners use text messaging. Digital health approaches can capitalize on the ubiquity of mobile technologies and allow investigators to reach affected populations with highly personalized content at low cost. Despite this ubiquity, interventions using text messaging for hypertension self-management primarily rely on reminders for tracking and medication adherence without diet and physical activity behaviors or feedback. As such, they are less effective. Investigators will establish the feasibility of a novel digital health-based approach for disseminating the DASH diet using the Amazon Alexa personal assistant. The data from this pilot feasibility trial will set the foundation for a larger, fully-powered R01 grant to examine whether DASH Cloud using Alexa can improve health outcomes. The primary aim of this proposal is to test the feasibility of the DASH Cloud intervention using Amazon Alexa.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Testing the Feasibility of the DASH Cloud Intervention Using Amazon Alexa
• Actual Study Start Date: Jul 23, 2018
• Actual Primary Completion Date: Dec 17, 2018
• Actual Study Completion Date: Dec 17, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Interventional DASH Cloud with Alexa

Behavioral: DASH cloud with Alexa; Participants will download and install the Alexa and Nutritionix application ("app") onto their smartphone and study staff will setup the study-specific account to send data to Duke's software system called Prompt. Participants will be instructed to invoke through voice their dietary intake daily for three months using the Nutritionix app through the Amazon Alexa personal assistant. DASH Cloud will access participant's dietary intake data through the Nutritionix application programing interface (API) for three months. Participants' 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 a daily or weekly feedback text message with a score reflecting DASH adherence for the prior days or week's food consumption using a previously validated scoring system.

Outcome Measures

Primary Outcome Measures

1. Intervention feasibility [3 months]

   Utilization of intervention components at 3 months as indicated by the system usability scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Over 21 years old;

• BMI >18.5 kg/m2;

• Current use of a smartphone with an updated operating system

• Data plan

• Willingness to be texted daily or weekly

• Wifi network at home

• An active 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Dori Steinberg, Ph.D, RD, Duke University
• Principal Investigator: Gary Bennett, Ph.D, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03455946
• Other Study ID Numbers: D0298
• First Posted: Mar 7, 2018
• Last Update Posted: Jul 25, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: Digital Health; Amazon Alexa

Study Results

No Results Posted as of Jul 25, 2019