Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Cleveland Clinic Akron General
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in participants' body weight
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
- •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.
Outcomes
Primary Outcomes
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
- Type 2 diabetes mellitus: 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 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(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(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(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Receipt of healthy food items: The Hunger Vital Sign scale(Baseline visit (W1) to week 16 visit)
- Receipt of healthy food items: Eating at America's Table scale(Baseline visit (W1) to week 16 visit)
- Type 2 diabetes mellitus: 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(Baseline visit (W1) to 16 week visit)
- Hypertension: Change in medication dosage(Baseline visit (W1) to 16 week visit)
- Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale(Baseline visit (W1) to week 16 visit)
- Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale(Baseline visit (W1) to 16-week visit)
- Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale(Baseline visit (W1) to 16-week visit)