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Healthy Foods and Education to Treat Diabetes

Farm to Clinic Vegetable Initiative at East Baltimore Medical Center

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03991026
Enrollment
29
Registered
2019-06-19
Start date
2019-06-18
Completion date
2019-09-26
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

The investigators will study a program that delivers weekly community-supported agriculture shares to patients of East Baltimore Medical Center in order to increase access to healthy foods. The investigators will provide adult patients with uncontrolled diabetes with healthy foods including fresh vegetables and shelf-stable pantry items (e.g., canned beans) every week over the course of 6 weeks. The investigators will also collect demographic data and food insecurity status of participants via survey. This program will also conduct weekly cooking and nutrition classes at East Baltimore Medical Center. The investigators will conduct a survey of participants' experiences each time participants pick up a vegetable bag and at the end of the cooking classes. In addition, a focus group of participants will be held to gather qualitative data regarding the vegetable initiative.

Interventions

BEHAVIORALHealthy food and Education/Cooking Classes

The intervention includes providing weekly seasonal produce and healthy foods to participants in addition to an education/cooking class that will be tailored to Diabetes Mellitus, Type II.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be randomly allocated to one of 2 groups: a control group or the intervention group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin \>8%) * 18 years age of and over * Living within the geographical region of East Baltimore Medical Campus

Exclusion criteria

* Current participation in Five Plus Nuts and Beans Study or other program that provides diet-based food * Non-English speaking * On hospice or palliative care * Acute or chronic psychosis * Active substance or alcohol use disorder * Another active medical disorder that would preclude participation in weekly food pick-up or classes including: active treatment of cancer, steroid dependent asthma/chronic obstructive pulmonary disease/emphysema, steroid dependent colitis; chronic kidney disease with an estimated glomerular filtration rate less than 30mg/mmol, venous thromboembolic disease with current treatment with vitamin K antagonist, Celiac disease, cirrhosis or steroid dependent arthritis

Design outcomes

Primary

MeasureTime frameDescription
Change in amount of vegetables eatenBaseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeksSelf-reported number of vegetables eaten per day (e.g. 2 vegetables/day) will be obtained by the survey.
Change in weight (kg)Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeksRecorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.
Change in Body mass index (kg/m^2)Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeksRecorded from EMR or calculated with height of record.

Secondary

MeasureTime frameDescription
Change in Glycosylated Hemoglobin level (percent of mmol/mol)Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeksRecorded from EMR.
Change in Blood pressure (mmHg)Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeksRecorded from EMR.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026