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Dash Cloud Digital Trial

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ClinicalTrials.gov Identifier: NCT03875768
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This trial will examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure, using the new blood pressure guidelines for non-pharmacological treatment. The primary outcome is 6-month change in DASH (Dietary Approaches to Stop Hypertension) adherence, as measured by 24-hour recalls. DASH adherence will be measured at 12-months post-randomization. Secondary outcomes include changes in blood pressure and other physiological outcomes (e.g. weight, lipids, glucose).

Condition or disease Intervention/treatment Phase
Hypertension Health Behavior Behavioral: Tracking Plus Coaching Not Applicable

Detailed Description:
Over 100 million Americans suffer from high blood pressure and thus are at increased risk for cardiovascular disease and premature morality. Evidence supports the DASH (Dietary Approaches to Stop Hypertension) dietary pattern to reduce blood pressure. DASH is rich in fruits and vegetables, legumes, lean protein, and low-fat dairy, and reduced in red meats, sweets and processed foods. In the past 20 years, numerous trials have demonstrated the blood pressure-lowering effects of DASH across a diverse range of populations. As such, DASH is part of national dietary and blood pressure guidelines. Despite this strong evidence, fewer than 1% of U.S. adults with high blood pressure fully meet DASH guidelines. Like most efficacious interventions, the rate-limiting step involves dissemination. Behavioral trials testing DASH have been delivered primarily in-person, an approach that is effective but not accessible to the broader population. Innovative and accessible strategies to disseminate DASH, such as digital health, are critically needed. To address this need, a feasibility of a 3-month digital health intervention called DASH Cloud was developed and tested. The DASH Cloud intervention asked participants to track their diet daily using a commonly-used commercial tracking app with an extensive nutrient database. The intervention technology platform extracted food and nutrient data from the app using an application programming interface (API). Each day, using this API software, the intervention compared individual participant's nutrient intake to the recommended levels in the DASH diet and then processed the data against an algorithm and sent automated text messages to each participant with information on DASH diet adherence and diet tips. Results indicated that individuals with elevated blood pressure were successfully recruited and retained, achieved high engagement with daily diet tracking and saw positive changes in diet quality. Based on the results of the feasibility trial, this trial will improve upon the personalization of the automated text messages and include a scalable and responsive way of delivering coaching, based on diet data received in the app. The efficacy of this approach will be tested via a fully-powered 12-month randomized controlled trial, DASH Cloud. The trial will examine the effects of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure, using the new blood pressure guidelines for nonpharmacological treatment. The primary outcome is 6-month change in DASH adherence, as measured by 24-hour recalls. This trial will also measure DASH adherence at 12-months post-randomization. Secondary outcomes include changes in blood pressure and other physiological outcomes (e.g. weight, lipids, glucose). The scientific premise of this proposal represents establishing the efficacy of a previously-deemed feasible approach for disseminating the DASH diet. With the millions of Americans in dire need of nonpharmacological treatments for blood pressure, the public health impact of disseminating the DASH Cloud intervention could drastically reduce the incidence of cardiovascular disease. The findings from this study prepare for a future implementation trial, testing the potential to implement DASH Cloud within clinics and other healthcare institutions, yielding a wider dissemination of this evidence-based intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
For 6-months, participants will track their diet daily using Nutritionix and receive automated feedback daily via text message based on their Dash score. In addition, participants will receive coaching when needed starting in week 2 of the study using colored zones based on the changes in their DASH score: Green zone: No coaching. Yellow zone: Text Coaching. Red zone: Coaching phone call.
Behavioral: Tracking Plus Coaching
For 6-months, participants will track their diet daily using Nutritionix and receive automated feedback daily via text message based on their Dash score and responsive coaching.

No Intervention: Control
For 6-months, participants will track their diet daily using Nutritionix and receive automated feedback daily via text message based on their Dash score.



Primary Outcome Measures :
  1. Change in Dietary Intake (Dash Score) [ Time Frame: Baseline, Follow-up months 1, 3, 6 and 12 ]
    Using the (ASA24) system, dietary intake data with 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day) at multiple time points.

  2. Change in DASH adherence using 24-hour Urine [ Time Frame: Baseline, Follow-up months 6 and 12 ]
    24-hour urine samples for assessment of urinary sodium, potassium, phosphorous, and urea nitrogen excretion.


Secondary Outcome Measures :
  1. Blood Pressure Changes [ Time Frame: Baseline, Follow-up months 1, 3, 6 and 12 ]
    Blood pressure measured in the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting.

  2. BMI Changes [ Time Frame: Baseline, Follow-up months 6 and 12 ]
    height and weight will be measured to calculate BMI (in light clothing, without shoes) and will be recorded in duplicate by trained staff using a high-quality, calibrated digital scale and a wall-mounted stadiometer.

  3. Changes in HbA1c [ Time Frame: Baseline, Follow-up months 6 and 12 ]
    We will measure fasting HbA1c. Finger stick blood samples will be collected at each evaluation visit, following an overnight fast, and will be analyzed using the Siemens HbA1c analyzer.

  4. Changes in Lipids [ Time Frame: Baseline, Follow-up months 6 and 12 ]
    We will measure a fasting lipid profile. Finger stick blood samples will be collected at each evaluation visit, following an overnight fast, and will be analyzed using the Cholestech LDX .

  5. Changes in Glucose [ Time Frame: Baseline, Follow-up months 6 and 12 ]
    We will measure a fasting glucose. Finger stick blood samples will be collected at each evaluation visit, following an overnight fast.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 18.5 kg/m2
  • Smartphone with a data plan
  • email address
  • willing to receive daily text messages
  • speaks English as primary language.

Exclusion Criteria:

  • participating in another related clinical trial
  • planning to leave the area during study time period
  • cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
  • active malignancy
  • recent psychiatric institutionalization
  • pregnancy or breastfeeding - current or planned during the study period
  • documented dementia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875768


Contacts
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Contact: Miriam Berger, MPH 9196138398 miriam.berger@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27708
Contact: Hallie Davis-Penders, M.Ed.    919-613-5455    hallie.davis.penders@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Dori Steinberg, PhD, MS, RD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03875768     History of Changes
Other Study ID Numbers: Pro00101689
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Dash Diet