RecruitingNot ApplicableNCT06921356

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

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

Sponsor

Johns Hopkins University

Enrollment

80 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension Type 2 Diabetes Mellitus (T2DM)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a lifestyle program that combines grocery support with health coaching to help adults manage both type 2 diabetes and high blood pressure. It focuses on people in Baltimore who live in areas where healthy food is hard to access. **You may be eligible if...** - You are 18 or older - You have type 2 diabetes (diagnosed, or HbA1c ≥6.5%, or on diabetes medications) - Your systolic blood pressure is between 120–159 mmHg - Your kidney function is adequate - You can complete study procedures in English - You live in a low-income, low-food-access area of Baltimore **You may NOT be eligible if...** - You had a severe low blood sugar episode requiring hospitalization in the last 6 months - You recently had a heart attack, stroke, or heart procedure - You are pregnant - You have advanced kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCoach-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.

BEHAVIORALSelf-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.