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OpenTrials
Completed

NCT Number: NCT06743191

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Access Nourish

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Feasibility of Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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