Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT06921356
- Status
- Recruiting
Conditions
- Hypertension
- Type 2 Diabetes Mellitus (T2DM)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention — BEHAVIORALParticipants 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.
- Self-Shopping DASH diet advice — BEHAVIORALParticipants 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.
Study Details
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.
Key Dates
- Start date
- May 15, 2025
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: Self-Shopping DASH diet advice group (S-DASH)
- Experimental: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
Primary Outcome Measure
Feasibility as assessed by the number of participants enrolled [ Time Frame: Baseline ]
Central Contacts
- Jessica Yeh, PhD410-614-4316
- Letitia Thomas410-281-1600
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins ProHealth Clinical Research Unit | Baltimore | Maryland | 21207 | Jessica Yeh, PhD (PRINCIPAL_INVESTIGATOR) |
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