Food as Medicine Study

NCT05346315 | Unknown

• 1 other identifier: 1329215
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Nutrition Disorders

Keywords

Dietitian; Feasibility; E-commerce

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change in body weight

  6 months

• Change in Body Mass Index (BMI)

  6 months

• Change in waist circumference

  6 months

• Change in total cholesterol (LDL, HDL, Triglycerides)

  6 months

• Change in fasting blood glucose

  6 months

Interventions

RDN Medical Nutrition Therapy OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead

Study Sites (3)

Amber Pharmacy

Omaha, Nebraska, 68138, United States

Location

Linden Market Hy-Vee

Omaha, Nebraska, 68154, United States

Location

Papillion Hy-Vee

Papillion, Nebraska, 68046, United States

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Constantina Papoutsakis, PhD, RD

  Academy of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: May 18, 2022
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)