Healthy Foods and Education to Treat Diabetes

NCT03991026 | Completed

• 1 other identifier: IRB00164545
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Glycosylated Hemoglobin level (percent of mmol/mol)

  Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

• Change in Blood pressure (mmHg)

  Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

Study Arms (2)

Healthy food and Education/Cooking Classes

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Healthy food and Education/Cooking Classes 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.

Healthy food and Education/Cooking Classes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin \>8%)
• years age of and over
• Living within the geographical region of East Baltimore Medical Campus

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Community Physicians at East Baltimore Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Donald RB Miles, MD

  Johns Hopkins Community Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to one of 2 groups: a control group or the intervention group.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: June 18, 2019
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)