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

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06743191
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-19
• Study Start: 2025-02-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by survey	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 Outcome Measures

Name	Time	Method
Change in DASH Score as assessed by the Automated Self-Administered 24-hour (ASA24)	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.
Change in Systolic Blood Pressure	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.
Change in Diastolic Blood Pressure	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.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States