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

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A total of 65 participants with hypertension and low access to high quality food will be enrolled to test the feasibility of using commercially available grocery delivery services, simultaneous to a robust behavioral intervention, to improve adherence to the Dietary Approaches to Stop Hypertension (DASH) eating pattern. The behavioral intervention will include 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. The primary outcome will be indicators of feasibility, including acceptability, demand, implementation and practicality and adaption. Change in DASH adherence and blood pressure will also be evaluated. The intervention period for participants will be 4 months.

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.

Is the digital health intervention for high blood pressure safe for humans?

The digital health intervention, which includes apps like NOOM and DASH To TEN, has been evaluated for quality and security, and these apps were found to be suitable for supporting the DASH diet, a healthy eating plan. While the studies focus on effectiveness and usability, no specific safety concerns for humans were reported in the available research. ^{1 2 3 4 5}

How is the treatment Access Nourish different from other treatments for high blood pressure?

Access Nourish is unique because it uses a digital health intervention to promote adherence to the DASH diet, which is a proven lifestyle approach to managing high blood pressure. This treatment leverages a smartphone app to provide real-time support and behavior change techniques, making it more accessible and engaging compared to traditional in-person or desktop-based interventions. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Access Nourish for high blood pressure?

Research shows that digital health tools, like the Nourish app, can help people with high blood pressure stick to the DASH diet, which is known to lower blood pressure. Additionally, digital interventions that encourage self-management and track daily behaviors have been linked to significant reductions in blood pressure. ^{2 3 6 7 8}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Digital interventions to promote self-management in adults with hypertension systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Hypertension Control and Patient Engagement Using Digital Tools. [2017]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]

7. Switzerland 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. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. [2022]