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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Type 2 Diabetes; Pre-diabetes
• Intervention / Treatment: Other: Medically-tailored meals; Other: Produce box and recipes

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic Akron General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-type 2 diabetes mellitus: Change in number of medications	Absolute 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	Percent 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	Absolute 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	Absolute 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	Percent change in medication dosage	From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Type 2 diabetes mellitus: Change in HbA1c	Absolute change in HbA1c	From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Hypertension: Change in number of medications	Absolute change in number of medications	Baseline visit (W1) to 16 week visit
Hypertension: Change in medication dosage	Percent change in medication dosage	Baseline visit (W1) to 16 week visit
Receipt of healthy food items: The Hunger Vital Sign scale	Values on the scale are: often true, sometimes true, and never true. A positive response to either or both of the first two values (often true, sometimes true) identifies households as being at risk for food insecurity	Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Eating at America's Table scale	Each reported frequency is expressed as a daily average ranging from 0 to 5. The estimate of the daily number of Pyramid/MyPyramid servings is calculated as average daily frequency x the number of Pyramid/MyPyramid servings for the portion size, summed across all food groups. A higher score for fruits and vegetables indicates a better outcome.	Baseline visit (W1) to week 16 visit
Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale	Eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score. Overall score is the sum of the 8 items. A score of 10 or greater is considered major depression, 20 or more is severe major depression.	Baseline visit (W1) to week 16 visit
Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale	Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome.	Baseline visit (W1) to 16-week visit
Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale	Six items, each of which is scored 0 to 10. Overall score is the mean of the 6 items. A higher score indicates a better outcome.	Baseline visit (W1) to 16-week visit

Collaborators and Investigators

• Sponsor: Cleveland Clinic Akron General
• Collaborators: The Cleveland Clinic; The University of Akron
• Investigators: Principal Investigator: Elliot B Davidson, MD, FAAFP, Cleveland Clinic Akron General

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Prediabetic State; Chronic Disease
• Other Study ID Numbers: 21029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No