Clinical trial NCT03991026: Healthy Foods and Education to Treat Diabetes
Official title: Farm to Clinic Vegetable Initiative at East Baltimore Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of 2 groups: a control group or the intervention group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in amount of vegetables eaten
timeFrame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
measure: Change in weight (kg)
timeFrame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
measure: Change in Body mass index (kg/m^2)
timeFrame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Secondary outcomes:
measure: Change in Glycosylated Hemoglobin level (percent of mmol/mol)
timeFrame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
measure: Change in Blood pressure (mmHg)
timeFrame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians at East Baltimore Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Community Physicians
name: Donald RB Miles, MD
role: PRINCIPAL_INVESTIGATOR
References: