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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.)

Locations
United States
Maryland
Johns Hopkins ProHealth Clinical Research Unit
RECRUITING
Baltimore
Contact Information
Primary
Jessica Yeh, PhD
hyeh1@jhmi.edu
410-614-4316
Backup
Letitia Thomas
410-281-1600
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 80
Treatments
Active_comparator: Self-Shopping DASH diet advice group (S-DASH)
Experimental: Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov