Status:
RECRUITING
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Hypertension
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18+ years
Phase:
NA
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 lowe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06921356
Start Date
May 15 2025
End Date
June 30 2026
Last Update
May 29 2025
Active Locations (1)
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1
Johns Hopkins ProHealth Clinical Research Unit
Baltimore, Maryland, United States, 21207