RECRUITING

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

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Conditions

HypertensionType 2 Diabetes Mellitus (T2DM)type 2 diabetesdiet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06921356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c\>=6.5%, or treatment of diabetes with diabetes medications(s)
  3. * Baseline systolic BP 120-159 mmHg (with or without medications.)
  4. * Serum potassium level \>3.0 and \<5 mmol/L,
  5. * Estimated glomerular filtration rate (eGFR) \>=45 mL/min/1.73m2.
  6. * Willing and able to complete required procedures in English.
  7. * 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.)
  1. * Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
  2. * Cardiovascular event within 6 months
  3. * 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
  4. * HbA1c ≥ 10%
  5. * Type 1 diabetes
  6. * Baseline systolic BP \< 100 mmHg
  7. * Weight \>400 lbs due to the maximum weight on study scale
  8. * Chronic disease that might interfere with trial participation
  9. * Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
  10. * Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
  11. * Unwillingness or inability to adopt a DASH-like diet
  12. * Planning to leave area in the next 6 months

Contacts and Locations

Study Contact

Jessica Yeh, PhD
CONTACT
410-614-4316
hyeh1@jhmi.edu
Letitia Thomas
CONTACT
410-281-1600

Principal Investigator

Jessica Yeh, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins ProHealth Clinical Research Unit
Baltimore, Maryland, 21207
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Jessica Yeh, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-05
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • hypertension
  • type 2 diabetes
  • diet

Additional Relevant MeSH Terms

  • Hypertension
  • Type 2 Diabetes Mellitus (T2DM)