HypertensionNCT06743191
Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
A study testing Access Nourish in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Access Nourish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Willing to receive daily text messages
- Can participate in online videoconference visits
- Can read and write in English
Who cannot join
- 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
Show all 10Show fewer
- Documented dementia
- On kidney dialysis
- Instructed to eat a low potassium diet
- Planned or recent bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 an online grocery delivery service 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.
- Conditions
- Hypertension
- Being tested
- Access Nourish
- Keywords
- Digital Health, Health Behavior, Nutrition, Hypertension, Food Access
- Medical subject headings
- Hypertension, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access NourishBehavioural
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 an online grocery delivery service 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.
| Study group | Role | What they receive |
|---|---|---|
| Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li | Experimental | 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 an online grocery delivery service and weekly grocery list recommendations from a health coach. All intervention will be delivered remotely using smartphone technology. Receives: Behavioral: Access Nourish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessed by Survey
Feasibility will be assessed via participant accrual, participant retention, and other indicators of feasibility by survey adapted from Bowen et al, including acceptability, demand, implementation, practicality, and adaptation of the intervention. The score scale ranged from 1-5, where 1 was strongly disagree and 5 was strongly agree.
Measured: 4 Months
Secondary outcomes (3)
DASH Score as Assessed by the Automated Self-Administered 24-hour (ASA24)
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.
Measured: Baseline, 2 months, and 4 months
Systolic Blood Pressure
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.
Measured: Baseline and 4 months
Diastolic Blood Pressure
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.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Feb 2025
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Hailey N Miller, RN, PhD, Principal investigator, Johns Hopkins UniversityGary G Bennett, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743191
- Sponsor's protocol ID
- IRB00447049
- Other IDs
- R21NR021041
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
- ClinicalTrials.gov ID
- NCT06743191
- Acronym / sponsor ID
- IRB00447049
- Conditions
- Hypertension
- Keywords
- Digital Health, Health Behavior, Nutrition, Hypertension, Food Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 an online grocery delivery service 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li | Experimental | Behavioral: Access NourishAll 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 an online grocery delivery service and weekly grocery list recommendations from a health coach. All intervention will be delivered remotely using smartphone technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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+
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access NourishA 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 an online grocery delivery service 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. | Behavioural | Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li |
Primary outcome
Feasibility Assessed by Survey
Time frame: 4 Months
Feasibility will be assessed via participant accrual, participant retention, and other indicators of feasibility by survey adapted from Bowen et al, including acceptability, demand, implementation, practicality, and adaptation of the intervention. The score scale ranged from 1-5, where 1 was strongly disagree and 5 was strongly agree.
3 secondary outcomes
DASH Score as Assessed by the Automated Self-Administered 24-hour (ASA24)
Time frame: Baseline, 2 months, and 4 months
Systolic Blood Pressure
Time frame: Baseline and 4 months
Diastolic Blood Pressure
Time frame: Baseline and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailey N Miller, RN, PhD principal investigator
Johns Hopkins University
Gary G Bennett, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access Nourish in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessed by Survey (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.