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Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875768
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The goal of Nourish is to help adults with high blood pressure enjoy an eating pattern called DASH (Dietary Approaches to Stop Hypertension) to lower blood pressure and improve health. Nourish will use a mobile app and information about DASH to help study participants follow the DASH dietary plan by tracking what they eat and drink every day. The primary outcome of the study is 6-month change in following the DASH eating plan, as measured by 24-hour dietary recalls. The secondary outcome is change in blood pressure. Study participation will last one year.

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 are at increased risk for cardiovascular disease. 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. The Nourish trial will look at the effect of the intervention on changes in dietary quality and blood pressure among men and women with high blood pressure. Participants who join Nourish will be asked to track what they eat and drink every day through a smartphone app and to participate in online study visits. Some participants will also receive additional support from a registered dietitian. We are doing this study to understand how technology can help adults with high blood pressure follow a heart-healthy eating plan to improve their blood pressure.

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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
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants will track their daily dietary intake for six months using an app and will receive automated feedback daily via text message based on DASH nutrients. Participants in-need of coaching based on their adherence to the key nutrients in the DASH dietary pattern or engagement in the intervention will receive responsive digital coaching from Nourish registered dietitians.
Behavioral: Tracking plus coaching
Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention.

No Intervention: Control
Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.



Primary Outcome Measures :
  1. Change in Dietary Intake (DASH Score) [ Time Frame: Baseline, Follow-up months 2, 4, 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.


Secondary Outcome Measures :
  1. Blood Pressure Changes [ Time Frame: Baseline, Follow-up months 2, 4, 6 and 12 ]
    Blood pressure measured in the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
  • BMI ≥ 18.5 kg/m2
  • Smartphone with a data plan
  • Willing to receive daily text messages
  • Valid email address
  • Willing and able to participate in online study videoconferencing visits (Zoom)
  • Lives in the U.S.
  • Reads and writes in English

Exclusion Criteria:

  • Participating in another related research study
  • Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
  • Active cancer
  • Recent hospitalization due to psychiatric condition or event
  • Pregnancy or breastfeeding - current or planned during the study period
  • Documented dementia
  • Lives with someone else participating in the Nourish study

To learn more about the study and to see if eligible to participate, visit www.nourishstudy.org


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 919-613-1591 nourish@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27708
Contact: Miriam Berger, MPH    919-613-1591    nourish@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Dori Steinberg, PhD, MS, RD Duke University
Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03875768    
Other Study ID Numbers: Pro00101689
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: June 2020
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:
Blood pressure
Hypertension
DASH
Nutrition
Dietary change
Mobile health
Digital health
E-health
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases