An interventional study of Healthy food box in Diabetes Type 2, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
Food insecurity increases an individual's risk of poor health outcomes from some of the most costly and preventable chronic diseases, including type 2 diabetes. The goal of this interventional pilot study is to see if primary care patients with self-reported food insecurity and a diagnosis of type 2 diabetes who receive 12 weekly home deliveries of fresh produce and diabetes-appropriate, shelf-stable food will have improved diabetes management. Half of these patients also received support from a community health worker (CHW) including nutrition and cooking education and tailored assistance accessing food resources and other social needs (example: transportation). The investigators hypothesized that participants receiving support from a CHW along with food boxes would have greater improvement in health outcomes compared to those participants who received only food.
Food Rx + CHW is a 3-month community health worker led medically tailored grocery intervention for patients with self-reported food insecurity and a diagnosis of type 2 diabetes at one academic medical center in the Midwest United States. Prior to contact and recruitment, eligible patients were randomly assigned to receive 12 weekly food deliveries and support from a CHW (Food + CHW group) or food deliveries only (Food-only group).
All participants receive 12 weekly contactless deliveries of food. CHWs conduct three virtual study visits with participants to administer surveys and/or collect biomarker measurements at weeks 1, 12, and 24. No changes in the frequency of visits with the patient's provider are recommended. Virtual visit 1 involves the completion of study forms, assessment of household size for most meals, cultural preferences, food allergies, baseline cooking and eating habits, and assessment for knowledge and usage of local and/or federal food support programs. At week 12, participants use at home kits and devices (provided by the study) to measure and report their HbA1C, weight and blood pressure and complete post-intervention surveys on diet, knowledge and usage of food access programs and resources, and an anonymous feedback questionnaire on the strengths and opportunities for improvement in the program. At week 24, participants measured and reported their final HbA1C, weight and self-collected blood pressure result.
In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example Supplemental Nutrition Assistance Program, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).
Each weekly food box contained approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. When local produce was not available, CHWs sourced produce from grocery stores.
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This study's enrollment of 47 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Behavioral: Healthy food box
Behavioral: Healthy food box
All participants received 12 weekly deliveries of food containing approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example SNAP, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).
Also known as: Community health worker
Change from baseline in average blood glucose, as measured by Hemoglobin A1C
Hemoglobin A1C point of care test
Time frame: Baseline, 3 months, 6 months
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center