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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Digital Health to Improve Diet Quality Among Adults at Risk for Cardiovascular Disease

Conditions
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Hypertension, Health Behavior

Intervention / Treatment
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* Behavioral: Tracking plus coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive information about the DASH dietary pattern and will track their daily dietary intake using an app for six months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dietary Intake (DASH Score) | Using the (ASA24) system, dietary intake data with 2 separate 24-hour dietary recalls (1 weekday and 1 weekend day) at multiple time points. | Baseline, Follow-up months 2, 4, 6 and 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Hypertension, DASH, Nutrition, Dietary change, Mobile health, Digital health, E-health