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CompletedNCT03455946Updated Jul 25, 2019

Testing the Feasibility of the DASH Cloud Intervention Using Amazon Alexa

An interventional study of DASH cloud with Alexa in Behavior, Health and Diet Modification, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Duke University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Behavior, Health
  • Diet Modification

Keywords

  • Digital Health
  • Amazon Alexa
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Interventional

    DASH Cloud with Alexa

    Behavioral: DASH cloud with Alexa

Interventions

  • BehavioralDASH 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.

05

What researchers measure

Primary outcomes

  1. Intervention feasibility

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

    Time frame: 3 months

06

Study locations

1 site
  • Duke University
    Durham, North Carolina 27705, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455946
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Jul 23, 2018
Primary completion
Dec 17, 2018
Completion
Dec 17, 2018
Last update
Jul 25, 2019

Study contacts

Dori Steinberg, Ph.D, RD
principal investigator · Duke University
Gary Bennett, Ph.D
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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