RecruitingNot Applicable

Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes

United States80 participantsStarted 2025-05-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 di…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility as assessed by the number of participants enrolled

Timeframe: Baseline

Acceptability as assessed by the Acceptability of the Intervention Measure survey

Timeframe: 3 months

Trial details

NCT IDNCT06921356

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Jessica Yeh, PhD

410-614-4316 hyeh1@jhmi.edu

View on ClinicalTrials.gov More Hypertension trials