- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06743191
Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
February 11, 2026 updated by: Johns Hopkins University
Feasibility of Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult 18 years of age or older
- Has hypertension, defined as a systolic BP of 130-159 mmHg and/or diastolic BP of 80-99 mmHg, whether or not taking hypertension medication.
- Resides in a census tract defined as low access by the United States Department of Agriculture (USDA)
- Resides in a zip code serviced by the grocery delivery app
- BMI 18.5 kg/m2+
- Has a smartphone with a data plan
- Willing to receive daily text messages
- Can participate in online videoconference visits
- Can read and write in English
Exclusion Criteria:
- Participating in another related research study
- Cardiovascular disease event in the last 6 months
- Active cancer
- Recent hospitalization due to psychiatric condition or event
- Pregnancy or planned during the study period
- BMI 37 kg/m2 or higher
- Documented dementia
- On kidney dialysis
- Instructed to eat a low potassium diet
- Planned or recent bariatric surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li
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.
|
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 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.
Participants will be able to complete all intervention components via smartphone.
The intervention period for participants will be 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility as assessed by survey
Time Frame: 4 months
|
Feasibility will be measured by a 23-item questionnaire used to assess participants' perceptions of the feasibility, usability, acceptability, practicality, and satisfaction with the intervention.
Each item is rated on a 5-point Likert scale, with higher scores indicating greater feasibility and acceptability.
The survey evaluates key components of the program, including grocery lists, grocery delivery, health coaching, and app-based tracking.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in DASH Score as assessed by the Automated Self-Administered 24-hour (ASA24)
Time Frame: Baseline and 4 months
|
Participants will enter dietary intake online via the National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment tool.
DASH dietary nutrients are then converted into a score.
Scores ranged from 0 to 9 where a higher score indicates better adherence to the DASH dietary pattern.
Change in DASH score = 4-month DASH score - Baseline DASH score.
|
Baseline and 4 months
|
|
Change in Systolic Blood Pressure
Time Frame: Baseline and 4 months
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting.
The final 2 measurements will be averaged together for analysis.
Change in systolic blood pressure = 4-month systolic blood pressure - Baseline systolic blood pressure.
|
Baseline and 4 months
|
|
Change in Diastolic Blood Pressure
Time Frame: Baseline and 4 months
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using the upper arm three times at 1-minute intervals after 5 minutes of quiet sitting.
The final 2 measurements will be averaged together for analysis.
Change in diastolic blood pressure = 4-month diastolic blood pressure - Baseline diastolic blood pressure.
|
Baseline and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary Bennett, PhD, Duke University
- Principal Investigator: Hailey Miller, RN, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2025
Primary Completion (Actual)
December 18, 2025
Study Completion (Actual)
December 18, 2025
Study Registration Dates
First Submitted
December 16, 2024
First Submitted That Met QC Criteria
December 18, 2024
First Posted (Actual)
December 19, 2024
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00447049
- R21NR021041 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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