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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05174078
• Other study ID #: 21029
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Akron General Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Hypertension
• Obesity
• Pre-diabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Akron General	Akron	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Akron General Medical Center	The Cleveland Clinic, The University of Akron

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hypertension: Change in number of medications	Absolute change in number of medications	Baseline visit (W1) to 16 week visit
Secondary	Hypertension: Change in medication dosage	Percent change in medication dosage	Baseline visit (W1) to 16 week visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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