NCT06921356 Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
| NCT ID | NCT06921356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-05-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Jessica Yeh, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06921356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921356 currently recruiting?
Yes, NCT06921356 is actively recruiting participants. Contact the research team at hyeh1@jhmi.edu for enrollment information.
Where is the NCT06921356 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06921356 clinical trial?
NCT06921356 is sponsored by Johns Hopkins University. The principal investigator is Jessica Yeh, PhD at Johns Hopkins University. The trial plans to enroll 80 participants.