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Completed

NCT Number: NCT03991026

Healthy Foods and Education to Treat Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Physicians at East Baltimore Medical Center

Baltimore, Maryland, 21202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in amount of vegetables eaten

    Time frame: 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.

  2. Change in weight (kg)

    Time frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

    Recorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.

  3. Change in Body mass index (kg/m^2)

    Time frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

    Recorded from EMR or calculated with height of record.

Secondary outcomes

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

    Time frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

    Recorded from EMR.

  2. Change in Blood pressure (mmHg)

    Time frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks

    Recorded from EMR.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Farm to Clinic Vegetable Initiative at East Baltimore Medical Center

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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