Dash Cloud Digital Trial

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.

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.