NCT06743191

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

December 16, 2024

Last Update Submit

February 11, 2026

Conditions

Keywords

Digital HealthHealth BehaviorNutritionHypertensionFood Access

Outcome Measures

Primary Outcomes (1)

  • Feasibility as assessed by survey

    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 Outcomes (3)

  • Change in DASH Score as assessed by the Automated Self-Administered 24-hour (ASA24)

    Baseline and 4 months

  • Change in Systolic Blood Pressure

    Baseline and 4 months

  • Change in Diastolic Blood Pressure

    Baseline and 4 months

Study Arms (1)

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 Instacart+ and weekly grocery list recommendations from a health coach. All intervention will be delivered remotely using smartphone technology.

Behavioral: Access Nourish

Interventions

Access NourishBEHAVIORAL

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.

Assess the feasibility of Access Nourish in a 4-month study among adults with hypertension li

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

HypertensionHealth Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Hailey Miller, RN, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Gary Bennett, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

February 27, 2025

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations