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

Not Applicable

Completed

• Conditions: Obesity; Hypertension; Pre-diabetes; Type 2 Diabetes

• Registration Number: NCT05174078
• Lead Sponsor: Cleveland Clinic Akron General

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Adults 18 years of age or older who are patients at Akron General Center for Family<br> Medicine<br><br> - Have body mass index (BMI) equal to or greater that 30kg/m2 AND<br><br> - Have at least one of the following diagnoses determined based on patients' problem<br> list in the electronic medical record (EMR) and the international classification of<br> diseases, 10th revision (ICD-10) codes:<br><br> 1. Pre-type 2 diabetes mellitus<br><br> 2. Type 2 diabetes mellitus<br><br> 3. Hypertension<br><br> - Have NOT participated in nutrition counseling at the University of Akron Nutrition<br> Center within the past 6 months<br><br>Exclusion Criteria:<br><br> - Food allergies<br><br> - Pregnant<br><br> - No access to internet<br><br> - Need English language interpretation<br><br> - Currently participating in a structured weight loss program or using weight loss<br> medications<br><br> - Any condition that, in the Investigator's judgement, interferes with the ability to<br> adhere to study requirements.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in participants' body weight

Secondary Outcome Measures

Name	Time	Method
Pre-type 2 diabetes mellitus: Change in number of medications;Pre-type 2 diabetes mellitus: Change in medication dosage;Pre-type 2 diabetes mellitus: Change in HbA1c;Type 2 diabetes mellitus: Change in number of medications;Type 2 diabetes mellitus: Change in medication dosage;Type 2 diabetes mellitus: Change in HbA1c;Hypertension: Change in number of medications;Hypertension: Change in medication dosage;Receipt of healthy food items: The Hunger Vital Sign scale;Receipt of healthy food items: Eating at America's Table scale;Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale;Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale;Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale