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NCT Number: NCT05174078

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hypertension Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Type 2 Diabetes Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in participants' body weight

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

    Percent weight loss

Secondary outcomes

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

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

    Absolute change in number of medications

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

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

    Percent change in medication dosage

  3. Pre-type 2 diabetes mellitus: Change in HbA1c

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

    Absolute change in HbA1c

  4. Type 2 diabetes mellitus: Change in number of medications

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

    Absolute change in number of medications

  5. Type 2 diabetes mellitus: Change in medication dosage

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

    Percent change in medication dosage

  6. Type 2 diabetes mellitus: Change in HbA1c

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

    Absolute change in HbA1c

  7. Hypertension: Change in number of medications

    Time frame: Baseline visit (W1) to 16 week visit

    Absolute change in number of medications

  8. Hypertension: Change in medication dosage

    Time frame: Baseline visit (W1) to 16 week visit

    Percent change in medication dosage

  9. Receipt of healthy food items: The Hunger Vital Sign scale

    Time frame: Baseline visit (W1) to week 16 visit

    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

  10. Receipt of healthy food items: Eating at America's Table scale

    Time frame: Baseline visit (W1) to week 16 visit

    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.

  11. Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale

    Time frame: Baseline visit (W1) to week 16 visit

    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.

  12. Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale

    Time frame: Baseline visit (W1) to 16-week visit

    Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome.

  13. Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale

    Time frame: Baseline visit (W1) to 16-week visit

    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.

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Akron General

Other

Collaborators

  • The Cleveland Clinic
  • The University of Akron

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 30, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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