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Food as Medicine Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05346315
Acronym
FaM
Enrollment
80
Registered
2022-04-26
Start date
2022-05-18
Completion date
2023-11-30
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Disorders

Keywords

Dietitian, Feasibility, E-commerce

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.

Interventions

OTHERRDN 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.

Sponsors

Academy of Nutrition and Dietetics
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in resolution of nutrition problem6 monthsPercent of resolution of nutrition problems
Change in eating pattern score6 monthsPicture your Plate Survey (Score ranges from minimum 0 to maximum 96 with 96 being the best score)

Secondary

MeasureTime frameDescription
Change in waist circumference6 monthsinches
Change in total cholesterol (LDL, HDL, Triglycerides)6 monthsmg/dL
Change in fasting blood glucose6 monthsmg/dL
Change in blood pressure (systolic and diastolic)6 monthsmmHg
Change in body weight6 monthspounds
Change in perceived shopping list adherence6 monthsPerceived compliance score (Score ranges from 1 minimum to 10 maximum with 10 being the best score)
Change in shopping frequency6 months\# orders place in the 6 month period vs. previous 6 months
Change in health quality of life6 monthsCDC's Health Related Quality of Life-14 Survey (Score is determined by overall healthy days vs. unhealthy days in a given month)
Change in basket size6 monthsDollars spent per order
Change in Body Mass Index (BMI)6 monthskg/m2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026