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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03215472
Collaborator
(none)
59
1
2
7.7
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: DASH Cloud
  • Other: Nutritionix Track app
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3-month randomized controlled trial to test the initial feasibility of DASH Cloud, a digital health intervention for women at risk for CVD3-month randomized controlled trial to test the initial feasibility of DASH Cloud, a digital health intervention for women at risk for CVD
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women at Risk for Cardiovascular Disease
Actual Study Start Date :
Jul 21, 2017
Actual Primary Completion Date :
Mar 12, 2018
Actual Study Completion Date :
Mar 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: DASH Cloud intervention

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.

Other: DASH Cloud
With DASH Cloud, the investigators will ask participants to track their diet daily using a commercial diet tracking app. The investigators will retrieve the diet data on our DASH Cloud platform and provide tailored feedback about a participant's DASH adherence via fully automated daily or weekly text messages. These feedback messages will describe both an individual's absolute performance and change over time. The investigators also include theory-driven tailored content that reinforces successes, offers motivational strategies, and offers short behavior change tips.

Experimental: Dash Light

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

Other: Nutritionix Track app
DASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.
Other Names:
  • DASH Light
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Change in Weight [Baseline, 3 months]

      Weight will be collected in kilograms at baseline and 3 months using a calibrated digital scale.

    3. Engagement [3 months]

      Utilization of intervention component (daily diet tracking using Nutritionix app) at 3 months. This will be measured by the proportion of participants completing daily dietary self-monitoring.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Sarah W. Stedman Nutrition and Metabolism Center Durham North Carolina United States 27708

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Dori M Steinberg, PhD, RD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03215472
    Other Study ID Numbers:
    • Pro00081972
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2018