Healthy Foods and Education to Treat Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Farm to Clinic Vegetable Initiative at East Baltimore Medical Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991026
• Other study ID #: IRB00164545
• Status: Completed
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: September 26, 2019

Study information

• Verified date: November 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Healthy 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Community Physicians at East Baltimore Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in amount of vegetables eaten	Self-reported number of vegetables eaten per day (e.g. 2 vegetables/day) will be obtained by the survey.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Primary	Change in weight (kg)	Recorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Primary	Change in Body mass index (kg/m^2)	Recorded from EMR or calculated with height of record.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Secondary	Change in Glycosylated Hemoglobin level (percent of mmol/mol)	Recorded from EMR.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Secondary	Change in Blood pressure (mmHg)	Recorded from EMR.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks