Food as Medicine Study

Nutrition Disorders Clinical Trial

— FaM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05346315
• Other study ID #: 1329215
• Status: Active, not recruiting
• Start date: May 18, 2022
• Est. completion date: November 2023

Study information

• Verified date: May 2022
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Amber Pharmacy	Omaha	Nebraska
United States	Linden Market Hy-Vee	Omaha	Nebraska
United States	Papillion Hy-Vee	Papillion	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in resolution of nutrition problem	Percent of resolution of nutrition problems	6 months
Primary	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	Change in body weight	pounds	6 months
Secondary	Change in Body Mass Index (BMI)	kg/m2	6 months
Secondary	Change in waist circumference	inches	6 months
Secondary	Change in total cholesterol (LDL, HDL, Triglycerides)	mg/dL	6 months
Secondary	Change in fasting blood glucose	mg/dL	6 months
Secondary	Change in blood pressure (systolic and diastolic)	mmHg	6 months
Secondary	Change in basket size	Dollars spent per order	6 months
Secondary	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
Secondary	Change in shopping frequency	# orders place in the 6 month period vs. previous 6 months	6 months
Secondary	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