Food as Medicine Study (FaM)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition Disorders
• Intervention / Treatment: Other: RDN Medical Nutrition Therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68138
      • Amber Pharmacy
    • Omaha, Nebraska, United States, 68154
      • Linden Market Hy-Vee
    • Papillion, Nebraska, United States, 68046
      • Papillion Hy-Vee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At least 18 years old; a resident of Nebraska or Iowa; have at least 1 of the following diagnoses that the person is not received nutrition counseling for: overweight / obesity, hypertension, cardiovascular disease, type 2 diabetes, or pre-diabetes; and willing to follow a meal plan and order groceries through Hy-Vee Aisles Online for 6-months.

Description

Inclusion Criteria:

1. 18+ years old
2. Household/participant willing to utilize the shopping list provided
3. 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.)
4. Nebraska or Iowa resident
5. 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
6. First visit with the RDN for the current medical diagnosis (may have received MNT for other conditions previously)
7. Access to Hy-Vee Aisles Online and NutriStyle, through the computer or mobile app
8. Willing to use Hy-Vee's Aisles Online e-commerce platform and NutriStyle
9. 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)
10. Current Hy-Vee fuel saver card holder, or willing to obtain a fuel saver card
11. Provide verbal and written communication and written informed consent in English

Exclusion Criteria:

1. Prescribed or taking over-the-counter weight loss medication at enrollment
2. Prescribed corticosteroids or other drug known to interfere with glucose metabolism
3. Scheduled for bariatric weight loss surgery during 6-month study intervention period
4. Pregnant/lactating
5. Currently working with another nutrition care professional

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academy of Nutrition and Dietetics
• Investigators: Principal Investigator: Constantina Papoutsakis, PhD, RD, Academy of Nutrition and Dietetics

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Feasibility; Dietitian; E-commerce
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: 1329215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No