Clinical trial NCT06921356: Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Type 2 Diabetes Mellitus (T2DM)
Keywords: hypertension
type 2 diabetes
diet
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as assessed by the number of participants enrolled
timeFrame: Baseline
measure: Acceptability as assessed by the Acceptability of the Intervention Measure survey
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ProHealth Clinical Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jessica Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References: