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

NCT ID: NCT05174078

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Medically-Tailored Meals (MTM)

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.

Group Type: EXPERIMENTAL

Medically-tailored meals

Intervention Type: OTHER

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.

Produce Box and Recipes

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.

Group Type: EXPERIMENTAL

Produce box and recipes

Intervention Type: OTHER

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.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

The University of Akron

OTHER

Sponsor Role: collaborator

Cleveland Clinic Akron General

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliot B Davidson, MD, FAAFP

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Akron General

Locations

Cleveland Clinic Akron General

Akron, Ohio, United States

Countries

United States

References

Kibera PW, Ofei-Tenkorang NA, Mullen C, Lear AM, Davidson EB. Food as medicine: a quasi-randomized control trial of two healthy food interventions for chronic disease management among ambulatory patients at an urban academic center. Prim Health Care Res Dev. 2023 Dec 21;24:e72. doi: 10.1017/S1463423623000579.

Reference Type: DERIVED

PMID: 38126528 (View on PubMed)

Other Identifiers

21029

Identifier Type: -

Identifier Source: org_study_id