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Food and Education Effects on Diabetes Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT04034511

Food and Education Effects on Diabetes Study

Low-income adults are disproportionately affected by diabetes, experiencing greater rates of diabetes, diabetes-related complications, and mortality. Dietary habits play an important role in achieving...

Lead sponsor: Johns Hopkins University•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Johns Hopkins University

Collaborators

Moveable Feast
Priority Partners MCO
Leonard & Helen R. Stulman Charitable Foundation
France-Merrick Foundation

The investigators will recruit 100 individuals age 18 and over with uncontrolled diabetes (defined as a hemoglobin A1c (HbA1c) \>8%) and enrolled in Priority Partners Medicaid insurance. Participants will be randomized to one of two groups: 1) 3 months of home-delivered, medically-tailored meals combined with monthly individual Medical Nutrition Therapy sessions for 6 months or 2) usual care. The investigators will follow participants for up to 12 months to assess for changes in hemoglobin A1c.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age 18 and over
•Diabetes with a hemoglobin A1c\>8%
•Medicaid beneficiary
•Enrolled in Medicaid Insurance

Exclusion Criteria

•Medical conditions that are indications for additional dietary requirements (e.g., advanced chronic kidney disease, end-stage renal disease, chronic wounds, or severe alcohol use disorder)
•Swallowing difficulties
•Food allergies
•Non-English speaking
•Language or hearing impairment
•Currently pregnant or breast feeding
•Does not have a refrigerator/freezer in the home to store meals
•Has plans to move out of the meal delivery service area in the next 12 months

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 10, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment74

Start dateJan 2020

Last updatedOct 10, 2023

Condition

Diabetes Mellitus, Type 2

Locations shown

Johns Hopkins University School of Medicine

Baltimore, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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