Food as Medicine Study
- Conditions
- Nutrition Disorders
- Registration Number
- NCT05346315
- Lead Sponsor
- Academy of Nutrition and Dietetics
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in resolution of nutrition problem 6 months Percent of resolution of nutrition problems
Change in eating pattern score 6 months Picture your Plate Survey (Score ranges from minimum 0 to maximum 96 with 96 being the best score)
- Secondary Outcome Measures
Name Time Method Change in body weight 6 months pounds
Change in waist circumference 6 months inches
Change in perceived shopping list adherence 6 months Perceived compliance score (Score ranges from 1 minimum to 10 maximum with 10 being the best score)
Change in Body Mass Index (BMI) 6 months kg/m2
Change in blood pressure (systolic and diastolic) 6 months mmHg
Change in shopping frequency 6 months # orders place in the 6 month period vs. previous 6 months
Change in total cholesterol (LDL, HDL, Triglycerides) 6 months mg/dL
Change in basket size 6 months Dollars spent per order
Change in health quality of life 6 months CDC's Health Related Quality of Life-14 Survey (Score is determined by overall healthy days vs. unhealthy days in a given month)
Change in fasting blood glucose 6 months mg/dL
Trial Locations
- Locations (3)
Amber Pharmacy
🇺🇸Omaha, Nebraska, United States
Linden Market Hy-Vee
🇺🇸Omaha, Nebraska, United States
Papillion Hy-Vee
🇺🇸Papillion, Nebraska, United States