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

NCT05174078 | Completed DMC

• 1 other identifier: 21029
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypertension; Pre-diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in participants' body weight

  Percent weight loss

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

Secondary Outcomes (13)

• Pre-type 2 diabetes mellitus: Change in number of medications

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

• Pre-type 2 diabetes mellitus: Change in medication dosage

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

• Pre-type 2 diabetes mellitus: Change in HbA1c

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

• Type 2 diabetes mellitus: Change in number of medications

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

• Type 2 diabetes mellitus: Change in medication dosage

  From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline

Study Arms (3)

Medically-Tailored Meals (MTM)

EXPERIMENTAL

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.

Other: Medically-tailored meals

Produce Box and Recipes

EXPERIMENTAL

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.

Other: Produce box and recipes

Standard of Care

NO INTERVENTION

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

Interventions

Medically-tailored meals 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.

Medically-Tailored Meals (MTM)

Produce box and recipes 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.

Produce Box and Recipes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Pre-type 2 diabetes mellitus
• Type 2 diabetes mellitus
• Hypertension
• Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cleveland Clinic Akron General: lead
• The Cleveland Clinic: collaborator
• The University of Akron: collaborator

Study Sites (1)

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Related Publications (1)

• 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.

  PMID: 38126528 DERIVED

MeSH Terms

Conditions

Obesity; Hypertension; Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Elliot B Davidson, MD, FAAFP

  Cleveland Clinic Akron General

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-randomized control trial

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 30, 2021
• Study Start: February 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)