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

Cleveland Clinic Akron General

Status: Completed

Conditions: Hypertension; Pre-diabetes; Obesity; Type 2 Diabetes

Treatments: Other: Produce box and recipes; Other: Medically-tailored meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05174078

21029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18 years of age or older who are patients at Akron General Center for Family Medicine

• Have body mass index (BMI) equal to or greater that 30kg/m2 AND

• Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes:

  1. Pre-type 2 diabetes mellitus
  2. Type 2 diabetes mellitus
  3. Hypertension

• Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months

Exclusion criteria

• Food allergies
• Pregnant
• No access to internet
• Need English language interpretation
• Currently participating in a structured weight loss program or using weight loss medications
• Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Medically-Tailored Meals (MTM)

Experimental group

Description:

Medically-tailored meals delivered to participants' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.

Treatment:

Other: Medically-tailored meals

Produce Box and Recipes

Experimental group

Description:

Weekly produce box delivered to participants' homes and access to recipes via the internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.

Treatment:

Other: Produce box and recipes

Standard of Care

No Intervention group

Description:

Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR).