Clinical trial NCT06743191: Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
Official title: Feasibility of Delivering a Digital Health Intervention to Improve Food Access and Dietary Quality Among Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Digital Health
Health Behavior
Nutrition
Hypertension
Food Access
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-12-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as assessed by survey
timeFrame: 4 months
Secondary outcomes:
measure: Change in DASH Score as assessed by the Automated Self-Administered 24-hour (ASA24)
timeFrame: Baseline and 4 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 4 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hailey Miller, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Gary Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References: