Food as Medicine Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate proof of concept that registered dietitian nutritionists (RDNs) can implement a Food as Medicine program that utilizes a grocery E-commerce platform in a food retail setting, and the process of measuring the outcomes is feasible.

Detailed Description
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The Academy of Nutrition and Dietetics Data Science Center (DSC) will implement the proposed prospective feasibility study. The study aims to measure change in nutrition problems, eating patterns, food purchasing patterns and health outcomes of participants who have agreed to receive a 6-month RDN-led Food as Medicine intervention program in the food retail setting. The intervention will be provided to all study participants and change will be evaluated in participants by comparing data at baseline and endline. The Food as Medicine intervention program will consist of: Personalized nutrition counseling (delivered in-person or telehealth, depending on preferences of the participant) by Hy-Vee RDNs. Personalized meal plans (based on program participants' individual anthropometrics, disease state, health goals, culture, food allergies / intolerances and eating preferences). The meal plans will be generated by the nutrition technology software, NutriStyle. Personalized shopping lists generated by a nutrition technology software (NutriStyle) and utilized for in-store grocery shopping, online grocery pick-up or online grocery delivery.

Official Title
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Registered Dietitian Nutritionist Led Food as Medicine Program in the Food Retail Setting: A Feasibility Study

Conditions
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Nutrition Disorders

Intervention / Treatment
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* Other: RDN Medical Nutrition Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years old Household/participant willing to utilize the shopping list provided No new medical diagnoses or medications (unrelated to the study intervention) within the last 3 months and no anticipated changes during the intervention period. (The participant may have a new medical diagnosis for which they are seeking MNT.) Nebraska or Iowa resident Minimum of one new self-reported diagnosis or an existing diagnosis that participant has not sought MNT for previously: Overweight/obesity, Hypertension, Cardiovascular disease, Pre-diabetes, Type 2 diabetes First visit with the RDN for the current medical diagnosis (may have received MNT for other conditions previously) Access to Hy-Vee Aisles Online and NutriStyle, through the computer or mobile app Willing to use Hy-Vee's Aisles Online e-commerce platform and NutriStyle Willing to meet with a Hy-Vee RDN regularly in person or via telehealth (and talk on the phone with the Hy-Vee RDN monthly) throughout the study intervention (6 months) Current Hy-Vee fuel saver card holder, or willing to obtain a fuel saver card Provide verbal and written communication and written informed consent in English Exclusion Criteria: Prescribed or taking over-the-counter weight loss medication at enrollment Prescribed corticosteroids or other drug known to interfere with glucose metabolism Scheduled for bariatric weight loss surgery during 6-month study intervention period Pregnant/lactating Currently working with another nutrition care professional

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: RDN Medical Nutrition Therapy|The RDNs will provide bi-monthly nutrition care, counseling, and dietary recommendations for a 6-month intervention, delivered either in-person or via telehealth, to the grocery store patrons during the study intervention. The RDN will provided care to the participant based upon the participant's unique dietary and nutritional needs. The RDN will provide nutrition recommendations and create meal plans via NutriStyle for the participants to follow. The meal plans will be uploaded into the grocery store's E-commerce shopping platform, which the participant can utilize to purchase foods that are needed to follow the RDNs nutrition recommendations for an individual person.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resolution of nutrition problem | Percent of resolution of nutrition problems | 6 months | 
| Change in eating pattern score | Picture your Plate Survey (Score ranges from minimum 0 to maximum 96 with 96 being the best score) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | pounds | 6 months | 
| Change in Body Mass Index (BMI) | kg/m2 | 6 months | 
| Change in waist circumference | inches | 6 months | 
| Change in total cholesterol (LDL, HDL, Triglycerides) | mg/dL | 6 months | 
| Change in fasting blood glucose | mg/dL | 6 months | 
| Change in blood pressure (systolic and diastolic) | mmHg | 6 months | 
| Change in basket size | Dollars spent per order | 6 months | 
| Change in perceived shopping list adherence | Perceived compliance score (Score ranges from 1 minimum to 10 maximum with 10 being the best score) | 6 months | 
| Change in shopping frequency | # orders place in the 6 month period vs. previous 6 months | 6 months | 
| Change in health quality of life | CDC's Health Related Quality of Life-14 Survey (Score is determined by overall healthy days vs. unhealthy days in a given month) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietitian, Feasibility, E-commerce