Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure
Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease
1 other identifier
interventional
301
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Sep 2020
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
September 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedResults Posted
Study results publicly available
August 16, 2024
CompletedAugust 16, 2024
March 1, 2024
2.5 years
March 13, 2019
March 13, 2024
March 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score
Participants entered their dietary intake online via the National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment tool to record 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day). DASH dietary nutrients are then converted into a score using the method described in Mellen et al (2008). Scores ranged from 0 to 9 where a higher score indicates better adherence to the DASH dietary pattern. Change in DASH score = 6-month DASH score - Baseline DASH score.
Baseline and 6 months
Secondary Outcomes (2)
Change in Systolic Blood Pressure
Baseline and 6 months
Change in Diastolic Blood Pressure
Baseline and 6 months
Study Arms (2)
Intervention
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participating in another related research study
- Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- Bariatric surgery in the last 12 months or planned during the study period
- Active cancer
- Recent hospitalization due to psychiatric condition or event
- Pregnancy- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary G. Bennett, PhD
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Gary G. Bennett, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 15, 2019
Study Start
September 29, 2020
Primary Completion
March 20, 2023
Study Completion
March 20, 2023
Last Updated
August 16, 2024
Results First Posted
August 16, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share