Healthy Foods and Education to Treat Diabetes

Farm to Clinic Vegetable Initiative at East Baltimore Medical Center

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Healthy food and Education/Cooking Classes

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Johns Hopkins Community Physicians at East Baltimore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy food and Education/Cooking Classes; At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, healthy eating attitudes, and demographics. Every week for 6 weeks, participants will pick-up a healthy food bag (e.g. fresh vegetables) for a $3 co-pay and attend an hour-long education classes at East Baltimore Medical Center. All participants will complete a survey at healthy food bag pick-up or an education class. Surveys at bag pick-up will ascertain outcomes like vegetable consumption. Surveys at education classes will ascertain outcomes like healthy eating attitudes. At 6 weeks, all participants will complete a follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again at 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.	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.
No Intervention: Control Group; At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, cooking habits, food security, healthy eating attitudes, and demographics. As a control group, participants will not partake in the healthy food bag pick-ups or cooking classes therefore they will not fill out those associated surveys. After the 6 weeks of the intervention, control participants will be given the follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again after 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Hemoglobin level (percent of mmol/mol)	Recorded from EMR.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks
Change in Blood pressure (mmHg)	Recorded from EMR.	Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Donald RB Miles, MD, Johns Hopkins Community Physicians

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB00164545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No