Healthy Foods and Education to Treat Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Healthy food and Education/Cooking Classes

• Registration Number: NCT03991026
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy food and Education/Cooking Classes	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Community Physicians at East Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States