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Food as Medicine Study (FaM)

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ClinicalTrials.gov Identifier: NCT05346315
Recruitment Status : Not yet recruiting
First Posted : April 26, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Academy of Nutrition and Dietetics

Study Description
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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.

Condition or disease Intervention/treatment
Nutrition Disorders 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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registered Dietitian Nutritionist Led Food as Medicine Program in the Food Retail Setting: A Feasibility Study
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nutrition

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Change in resolution of nutrition problem [ Time Frame: 6 months ]
    Percent of resolution of nutrition problems

  2. Change in eating pattern score [ Time Frame: 6 months ]
    Picture your Plate Survey (Score ranges from minimum 0 to maximum 96 with 96 being the best score)


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: 6 months ]
    pounds

  2. Change in Body Mass Index (BMI) [ Time Frame: 6 months ]
    kg/m2

  3. Change in waist circumference [ Time Frame: 6 months ]
    inches

  4. Change in total cholesterol (LDL, HDL, Triglycerides) [ Time Frame: 6 months ]
    mg/dL

  5. Change in fasting blood glucose [ Time Frame: 6 months ]
    mg/dL

  6. Change in blood pressure (systolic and diastolic) [ Time Frame: 6 months ]
    mmHg

  7. Change in basket size [ Time Frame: 6 months ]
    Dollars spent per order

  8. Change in perceived shopping list adherence [ Time Frame: 6 months ]
    Perceived compliance score (Score ranges from 1 minimum to 10 maximum with 10 being the best score)

  9. Change in shopping frequency [ Time Frame: 6 months ]
    # orders place in the 6 month period vs. previous 6 months

  10. Change in health quality of life [ Time Frame: 6 months ]
    CDC's Health Related Quality of Life-14 Survey (Score is determined by overall healthy days vs. unhealthy days in a given month)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05346315


Contacts
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Contact: Constantina Papoutsakis, PhD, RD 312-899-4721 cpapoutsakis@eatright.org
Contact: Allison Yoder, MA, RDN, LD ayoder@eatright.org

Locations
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United States, Nebraska
Amber Pharmacy
Omaha, Nebraska, United States, 68138
Contact: Megan Hall    402-896-4873      
Linden Market Hy-Vee
Omaha, Nebraska, United States, 68154
Contact: Shelly Asplin    402-493-2911 ext 164      
Papillion Hy-Vee
Papillion, Nebraska, United States, 68046
Contact: Laura Johansen    402-597-5790      
Sponsors and Collaborators
Academy of Nutrition and Dietetics
Investigators
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Principal Investigator: Constantina Papoutsakis, PhD, RD Academy of Nutrition and Dietetics
More Information
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Responsible Party: Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier: NCT05346315    
Other Study ID Numbers: 1329215
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Academy of Nutrition and Dietetics:
Dietitian
Feasibility
E-commerce
Additional relevant MeSH terms:
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Nutrition Disorders