Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
NCT ID: NCT06921356
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2025-05-15
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women
NCT03215472
The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
NCT04421755
Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension
NCT05565716
Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes
NCT06033664
Digital Intervention Participation in DASH
NCT04515303
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-Shopping DASH diet advice group (S-DASH)
Self-Shopping DASH diet advice
Participants 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.
Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention (C-DASH)
Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention
Participants 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Coach-Directed Tailored DASH Groceries Plus Lifestyle Intervention
Participants 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
Participants 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jessica Yeh, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins ProHealth Clinical Research Unit
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Letitia Thomas
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00425074
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.