NCT05174078

Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Cleveland Clinic Akron General · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.

Detailed description

Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.

Conditions

• Obesity
• Hypertension
• Pre-diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Medically-tailored meals	Medically tailored meals delivered to patients' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.
OTHER	Produce box and recipes	Weekly produce box and access to recipes via internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2021-12-30
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States