Digital Health Intervention for High Blood Pressure

Overseen By Hailey Miller, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cardiovascular disease, Active cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if grocery delivery services, combined with personalized health coaching, can help individuals adhere to the heart-healthy DASH diet, which may lower high blood pressure. Participants will receive skills training, set nutrition goals, and get personalized text feedback, along with an Instacart+ membership for grocery deliveries. It is ideal for adults with high blood pressure who live in areas with limited access to quality food and have a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could significantly improve heart health.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It mentions that participants can have hypertension whether or not they are taking medication, so it seems likely you can continue your current treatment.

What prior data suggests that this digital health intervention is safe for individuals with hypertension?

Research has shown that digital health tools like Access Nourish are generally safe for people with high blood pressure. Past studies found that these tools can help individuals adhere to the DASH eating plan, which is known to control blood pressure. Importantly, these studies did not identify any major negative effects from using the digital tool itself, suggesting it is well-tolerated by users.

In this trial, participants will use a digital method to improve their diet and manage their blood pressure. They will receive support such as skills training, grocery delivery, and personalized feedback. This type of digital health tool has been tested in other contexts and has proven safe and effective in helping manage blood pressure without major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for high blood pressure, which often involves medications like ACE inhibitors or beta-blockers, Access Nourish is a digital health intervention that offers a fresh approach. Researchers are excited about this treatment because it combines skills training, nutrient goal setting, and personalized feedback, all delivered remotely through smartphone technology. This innovative method not only empowers individuals to manage their health actively but also provides practical support with features like Instacart+ memberships and tailored grocery lists, aiming to make healthy living more accessible and sustainable.

What evidence suggests that this digital health intervention is effective for high blood pressure?

Research has shown that digital health tools, like Access Nourish, can help individuals adhere to the DASH diet, which lowers blood pressure. In this trial, all participants will receive the Access Nourish intervention, including digital tools, grocery delivery, and personalized coaching to facilitate healthy eating. One study found that a similar digital program improved diet quality and lowered blood pressure in individuals with hypertension. However, it did not outperform a group receiving similar attention, suggesting its effectiveness may vary among individuals. This approach supports people in managing high blood pressure by aiding adherence to a heart-healthy diet. ^{1 2 3 4 6}

Who Is on the Research Team?

Gary Bennett, PhD

Principal Investigator

Duke University

Hailey Miller, RN, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults 18+ with hypertension (130-159 mmHg systolic or 80-99 mmHg diastolic), living in low-access food areas as defined by the USDA, and serviced by a grocery delivery app. Participants must have a BMI of at least 18.5, own a smartphone with data, be willing to receive daily texts, attend video calls, and read/write English.

Inclusion Criteria

I can join video calls for my appointments.

I can read and write in English.

I own a smartphone with an active data plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digital health intervention including skills training, nutrient goal setting, self-monitoring, personalized feedback, and health coaching for 4 months

4 months

Remote intervention using smartphone technology

Follow-up

Participants are monitored for changes in DASH adherence and blood pressure after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Access Nourish

Trial Overview The trial is testing 'Access Nourish,' which combines grocery delivery via Instacart+ with behavioral interventions like skills training and health coaching to improve adherence to the DASH diet for better blood pressure control over four months.

How Is the Trial Designed?

Group I: Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li Experimental Treatment 1 Intervention

All participants will be prospectively assigned to receive a behavioral intervention that includes skills training, nutrient goal setting, self-monitoring via dietary tracking, personalized text message feedback, and adaptive health coaching. Participants will also receive a membership to Instacart+ and weekly grocery list recommendations from a health coach. All intervention will be delivered remotely using smartphone technology.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

Interactive digital interventions (IDIs) significantly reduce systolic blood pressure (SBP) by an average of -3.74 mmHg compared to usual care, based on a systematic review of randomized controlled trials involving adults with hypertension.

While IDIs also lower diastolic blood pressure (DBP) by -2.37 mmHg, there is considerable variability in the results, indicating that while effective, the long-term sustainability and clinical effectiveness of these interventions need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions to promote self-management in adults with hypertension systematic review and meta-analysis. McLean, G., Band, R., Saunderson, K., et al.[2022]

In a study of 156 patients with uncontrolled hypertension using a home-based digital-medicine program, 71% achieved target blood pressure control after 90 days, compared to only 31% in a usual-care group.

The digital-medicine approach not only significantly reduced blood pressure (average decrease of 14/5 mm Hg) but also led to a substantial decrease in excess sodium consumption and improved patient engagement, indicating its effectiveness and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Hypertension Control and Patient Engagement Using Digital Tools. Milani, RV., Lavie, CJ., Bober, RM., et al.[2017]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

The Keenoa™ app was preferred over traditional pen and paper methods for diet recording among participants, indicating a positive user experience with digital data collection.

While the app had strengths like picture recognition and a pleasant interface, challenges such as barcode scanning issues and a limited food database were noted, suggesting areas for improvement to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. Bouzo, V., Plourde, H., Beckenstein, H., et al.[2022]

The DASH Mobile system is designed to help hypertensive patients adopt the DASH diet, which emphasizes fruits, vegetables, low-fat dairy, and lean protein, while also promoting physical activity and reducing sodium intake.

This mobile health (mHealth) app aims to make it easier for users to track their diet and health metrics, potentially overcoming the challenges of traditional in-person interventions and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. Mann, DM., Kudesia, V., Reddy, S., et al.[2013]

In a post-hoc analysis of the HERB-DH1 trial involving 156 patients with hypertension, a higher count of daily self-reported behavioral efficacy records (SER) was linked to greater reductions in morning systolic blood pressure (SBP), indicating that tracking lifestyle changes can effectively lower BP.

Specifically, patients who reported more on their salt intake and weight reduction showed significant decreases in SBP, suggesting that enhancing self-monitoring through digital therapeutics can improve patient outcomes in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily self-reported behavioural efficacy records on hypertension digital therapeutics as digital metrics associated with the reduction in morning home blood pressure: post-hoc analysis of HERB-DH1 trial. Hisaki, F., Aga, M., Tomitani, N., et al.[2023]

The Nourish trial will involve 300 adults with hypertension over 12 months, testing a smartphone app designed to improve adherence to the DASH eating pattern, which is a proven method for managing high blood pressure.

The primary goal is to see if this digital health intervention can significantly enhance adherence to the DASH diet and lead to reductions in blood pressure, using evidence-based behavior change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension. Miller, HN., Berger, MB., Askew, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8556291/

The Nourish Protocol: A digital health randomized ... Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure.

2. clinicaltrials.gov clinicaltrials.gov/show/NCT03875768

Nourish: A Digital Health Program to Promote the DASH ... 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.

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.124.23887?doi=10.1161/HYPERTENSIONAHA.124.23887

Effects of a Digital Intervention to Improve DASH and Blood ... A DHI led to modest improvements in DASH and blood pressure among adults with hypertension but did not outperform the attention control.

4. withpower.com withpower.com/trial/phase-hypertension-2025-b88d7

Digital Health Intervention for High Blood Pressure What data supports the effectiveness of the treatment Access Nourish for high blood pressure? Research shows that digital health tools, like the Nourish app ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/68/NCT03875768/Prot_SAP_ICF_001.pdf

Nourish: Using digital health to improve diet quality among ... In the pilot trial, we had 10% attrition with diet and blood pressure outcomes. Our primary model estimates intervention effects while accounting for missing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12413951/

Digital-Based Nutrition Interventions Employing the Dietary ... Interventions using the DASH dietary pattern positively affected blood pressure (BP), nutrition behavior, and weight. Some studies also reported secondary ...