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

Not Applicable

Recruiting

• Conditions: Hypertension; Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06921356
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Study Start: 2025-05-15
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by the number of participants enrolled	Baseline	The observed count of responses to the prescreening will be summarized. Recruitment yields at screening visit and randomization visit will be derived.
Acceptability as assessed by the Acceptability of the Intervention Measure survey	3 months	Acceptability of the intervention will be quantitatively measured by the Acceptability of Intervention Measure (AIM) survey. The survey consists of 4 items, each measured on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The score is calculated as the mean of the responses to the 4 items. A higher score is better.

Trial Locations

Locations (1)

Johns Hopkins ProHealth Clinical Research Unit; 🇺🇸 Baltimore, Maryland, United States