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

Primary Purpose

Obesity, Hypertension, Pre-diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medically-tailored meals
Produce box and recipes
Sponsored by
Cleveland Clinic Akron General
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cleveland Clinic Akron General

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Medically-Tailored Meals (MTM)

Produce Box and Recipes

Standard of Care

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in participants' body weight
Percent weight loss

Secondary Outcome Measures

Pre-type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Pre-type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Pre-type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Type 2 diabetes mellitus: Change in number of medications
Absolute change in number of medications
Type 2 diabetes mellitus: Change in medication dosage
Percent change in medication dosage
Type 2 diabetes mellitus: Change in HbA1c
Absolute change in HbA1c
Hypertension: Change in number of medications
Absolute change in number of medications
Hypertension: Change in medication dosage
Percent change in medication dosage
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
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.
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.
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.
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.

Full Information

First Posted
December 1, 2021
Last Updated
March 10, 2023
Sponsor
Cleveland Clinic Akron General
Collaborators
The Cleveland Clinic, The University of Akron
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1. Study Identification

Unique Protocol Identification Number
NCT05174078
Brief Title
Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
Official Title
Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cleveland Clinic Akron General
Collaborators
The Cleveland Clinic, The University of Akron

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension, Pre-diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A quasi-randomized control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medically-Tailored Meals (MTM)
Arm Type
Experimental
Arm 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.
Arm Title
Produce Box and Recipes
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR).
Intervention Type
Other
Intervention Name(s)
Medically-tailored meals
Intervention Description
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
Intervention Name(s)
Produce box and recipes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in participants' body weight
Description
Percent weight loss
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Secondary Outcome Measure Information:
Title
Pre-type 2 diabetes mellitus: Change in number of medications
Description
Absolute change in number of medications
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Pre-type 2 diabetes mellitus: Change in medication dosage
Description
Percent change in medication dosage
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Pre-type 2 diabetes mellitus: Change in HbA1c
Description
Absolute change in HbA1c
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Type 2 diabetes mellitus: Change in number of medications
Description
Absolute change in number of medications
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Type 2 diabetes mellitus: Change in medication dosage
Description
Percent change in medication dosage
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Type 2 diabetes mellitus: Change in HbA1c
Description
Absolute change in HbA1c
Time Frame
From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Title
Hypertension: Change in number of medications
Description
Absolute change in number of medications
Time Frame
Baseline visit (W1) to 16 week visit
Title
Hypertension: Change in medication dosage
Description
Percent change in medication dosage
Time Frame
Baseline visit (W1) to 16 week visit
Title
Receipt of healthy food items: The Hunger Vital Sign scale
Description
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
Time Frame
Baseline visit (W1) to week 16 visit
Title
Receipt of healthy food items: Eating at America's Table scale
Description
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.
Time Frame
Baseline visit (W1) to week 16 visit
Title
Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale
Description
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.
Time Frame
Baseline visit (W1) to week 16 visit
Title
Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale
Description
Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome.
Time Frame
Baseline visit (W1) to 16-week visit
Title
Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale
Description
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.
Time Frame
Baseline visit (W1) to 16-week visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot B Davidson, MD, FAAFP
Organizational Affiliation
Cleveland Clinic Akron General
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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