Clinical trial NCT03875768: Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure
Official title: Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Health Behavior
Keywords: Blood pressure
Hypertension
DASH
Nutrition
Dietary change
Mobile health
Digital health
E-health
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Change in Dietary Intake as Measured by Dietary Approaches to Stop Hypertension (DASH) Score
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Gary G. Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References: