Clinical trial NCT05346315: Food as Medicine Study
Official title: Registered Dietitian Nutritionist Led Food as Medicine Program in the Food Retail Setting: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Disorders
Keywords: Dietitian
Feasibility
E-commerce
Lead sponsor: Academy of Nutrition and Dietetics
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in resolution of nutrition problem
timeFrame: 6 months
measure: Change in eating pattern score
timeFrame: 6 months
Secondary outcomes:
measure: Change in body weight
timeFrame: 6 months
measure: Change in Body Mass Index (BMI)
timeFrame: 6 months
measure: Change in waist circumference
timeFrame: 6 months
measure: Change in total cholesterol (LDL, HDL, Triglycerides)
timeFrame: 6 months
measure: Change in fasting blood glucose
timeFrame: 6 months
measure: Change in blood pressure (systolic and diastolic)
timeFrame: 6 months
measure: Change in basket size
timeFrame: 6 months
measure: Change in perceived shopping list adherence
timeFrame: 6 months
measure: Change in shopping frequency
timeFrame: 6 months
measure: Change in health quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Amber Pharmacy
state: Nebraska
city: Omaha
country: United States
facility: Linden Market Hy-Vee
state: Nebraska
city: Papillion
country: United States
facility: Papillion Hy-Vee
state: Nebraska
Study officials:
affiliation: Academy of Nutrition and Dietetics
name: Constantina Papoutsakis, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: