NCT03455946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

December 27, 2017

Last Update Submit

July 24, 2019

Conditions

Keywords

Digital HealthAmazon Alexa

Outcome Measures

Primary Outcomes (1)

  • Intervention feasibility

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

    3 months

Study Arms (1)

Interventional

EXPERIMENTAL

DASH Cloud with Alexa

Behavioral: DASH cloud with Alexa

Interventions

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.

Interventional

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • CVD event in prior 6 months
  • Active malignancy
  • Active psychosis or recent psychiatric institutionalization
  • Current pregnancy or lactation
  • Current participation in a similar trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dori Steinberg, Ph.D, RD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Gary Bennett, Ph.D

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2017

First Posted

March 7, 2018

Study Start

July 23, 2018

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations