Healthy Foods and Education to Treat Diabetes

NCT ID: NCT03991026

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2019-09-26

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy food and Education/Cooking Classes

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald RB Miles, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Community Physicians

Locations

Johns Hopkins Community Physicians at East Baltimore Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00164545

Identifier Type: -

Identifier Source: org_study_id