Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes (DASH-Life)

March 23, 2026 updated by: Johns Hopkins University

Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes Residing in Urban Food Deserts (DASH-Life): Pilot Randomized Clinical Trial

People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jessica Yeh, PhD
  • Phone Number: 410-614-4316
  • Email: hyeh1@jhmi.edu

Study Contact Backup

  • Name: Letitia Thomas
  • Phone Number: 410-281-1600

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • Recruiting
        • Johns Hopkins ProHealth Clinical Research Unit
        • Contact:
        • Principal Investigator:
          • Jessica Yeh, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c>=6.5%, or treatment of diabetes with diabetes medications(s)
  • Baseline systolic BP 120-159 mmHg (with or without medications.)
  • Serum potassium level >3.0 and <5 mmol/L,
  • Estimated glomerular filtration rate (eGFR) >=45 mL/min/1.73m2.
  • Willing and able to complete required procedures in English.
  • Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile>=6.)

Exclusion Criteria:

  • Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
  • Cardiovascular event within 6 months
  • On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications
  • HbA1c ≥ 10%
  • Type 1 diabetes
  • Baseline systolic BP < 100 mmHg
  • Weight >400 lbs due to the maximum weight on study scale
  • Chronic disease that might interfere with trial participation
  • Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
  • Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
  • Unwillingness or inability to adopt a DASH-like diet
  • Planning to leave area in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-Shopping DASH diet advice group (S-DASH)
Behavioral: Self-Shopping DASH diet advice
Participants assigned to the S-DASH group will receive a brochure about the DASH eating plan. For the first three months, Participants will also receive a gift card to shop at a local supermarket. During months 4-6, participants will be asked to continue following the DASH eating plan listed in the brochure but will no longer be provided the grocery gift card.
Experimental: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
Behavioral: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention
Participants assigned to the C-DASH group will meet by telephone with the study coach for 1 hour, and then have brief weekly conversations (about 15-30 minutes) by phone during the first three months. During these weekly calls, the study coach will assist participant with selecting fruits, vegetables, nuts, and beans. During months 4-6, the study coach will continue to work with participant to set goals for following the DASH-Life way of eating, but the study will no longer provide a weekly food allowance to purchase groceries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as assessed by the number of participants enrolled
Time Frame: Baseline
The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived.
Baseline
Acceptability as assessed by the Acceptability of the Intervention Measure survey
Time Frame: 3 months
Acceptability of the intervention will be quantitatively measured by the Acceptability of Intervention Measure (AIM) survey. The survey consists of 4 items, each measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The score is calculated as the mean of the responses to the 4 items. A higher score is better.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Jessica Yeh, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00425074
  • P50MD017348 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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