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The Good Food Rx: Food-as-medicine Program

Primary Purpose

Hypertension, Diabetes Mellitus, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food as medicine
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals, 18-years old and older
  • Diagnosed with a chronic health morbidity such as hypertension, elevated A1C, hyperlipidemia and/or obesity.
  • A patient at UAMS East Family Medical Center in Helena, Arkansas.

Exclusion Criteria:

  • Participants 17-years old and younger are excluded from The Good Food Rx program.
  • Participants who are generally healthy and do not have chronic morbidities such hypertension, elevated A1C, hyperlipidemia and obesity.

Sites / Locations

  • UAMS East - Helena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational sessions plus a nutrition box and recipes

Arm Description

Monthly nutrition education sessions will be attended by the subjects and then each subject will receive a free nutrition box that includes recipes that pertain to the food contents in the prepackaged box

Outcomes

Primary Outcome Measures

Blood Pressure - 3 month
blood pressure will be collected
Blood Pressure - 6 month
blood pressure will be collected
Blood Pressure - 9 month
blood pressure will be collected
Blood Pressure - 12 month
blood pressure will be collected
hemoglobin A1C - 3 month
routine hemoglobin A1C will be determined
hemoglobin A1C - 6 month
routine hemoglobin A1C will be determined
hemoglobin A1C - 9 month
routine hemoglobin A1C will be determined
hemoglobin A1C - 12 month
routine hemoglobin A1C will be determined
Total Cholesterol - 6 month
total cholesterol will be determined from routine clinic visits
Total Cholesterol - 12 month
total cholesterol will be determined from routine clinic visits
Body Weight - 3 month
Body weigh in lbs will be collected at routine clinic visits
Body Weight - 6 month
Body weigh in lbs will be collected at routine clinic visits
Body Weight - 9 month
Body weigh in lbs will be collected at routine clinic visits
Body Weight - 12 month
Body weigh in lbs will be collected at routine clinic visits

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
October 17, 2023
Sponsor
University of Arkansas
Collaborators
USDA Beltsville Human Nutrition Research Center, Well Fed, Arkansas Community Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05541458
Brief Title
The Good Food Rx: Food-as-medicine Program
Official Title
Alleviating Chronic Morbidities and Food Insecurity by Launching a Food-as-medicine Program Called: The Good Food Rx
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
USDA Beltsville Human Nutrition Research Center, Well Fed, Arkansas Community Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study seeks to recruit 25 participants who meet program criteria by alleviating chronic morbidities that plague this region by providing participants with nutritional food boxes partnered with nutrition education classes to determine impact and potential benefits of using food as medicine. The key measures seeking to be examined in the program are reducing food insecurity, healthy food consumption, increased nutrition education, and a decrease in biometrics such as hypertension, A1C levels, hyperlipidemia indices, and obesity. UAMS East seeks to alleviate chronic morbidities and food insecurity by launching a food-as-medicine program called The Good Food Rx. The Good Food Rx Program couples established nutrition education classes participation with, at the same time, providing healthy curated nutritional food boxes to at-risk individuals.
Detailed Description
Study Design and Procedures In this study, the Principal Investigator, Director of Outreach, Food RX Program Coordinator and/or Heath Educator are considered "study personnel." The chronological study design of The Good Food Rx program are as follow: Participants will be identified for study/program participation by the Principal Investigator using medical health records and/or a referral from a UAMS East nurse or doctor. Flyers will also be present in the clinic for participant attraction. Prospective participants inquiring about the study will have their medical records reviewed by the Principal Investigator for enrollment qualification. Once identified, these prospective participants will be referred to the Director of Outreach or a Good Food Rx Coordinator and/or Health Educator who will contact them to schedule an appointment to discuss the study and sign the informed consent and HIPAA Research Authorization forms if so desired. The prospective participants will be asked to come to the clinic to meet with study personnel in their offices for this intake. This visit is considered a research-only function that will not consume any clinical space or clinical staff time. If a participant decides to be in the study, in addition to signing the informed consent and HIPAA Research Authorization forms , they will be asked to sign an enrollment application, a photography release agreement consent form and complete a pre - assessment nutritional profile. Upon enrollment, the participant will be expected to attend bi - monthly, 30 minutes to 1 hour, nutrition education classes facilitated by UAMS East outreach staff on a variety of subjects such as meal planning, reading food labels, portion awareness, smart shopping and budgeting, as well as other topic concerning healthy eating. These bi - monthly nutrition educational classes will be present in either a group setting or individually depending on participant attendance. Once the participant has completed the nutrition education sessions, they will receive a free nutrition box that includes recipes using the food contents from the prepackaged box. Participants will be in the active study for 12 months, where the participants will attend the nutrition education classes and have their routine laboratory data collected, followed by an additional 12 months where the same data collected during the active part of the study data will be collected from the participants' electronic medical records for comparison to the active portion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational sessions plus a nutrition box and recipes
Arm Type
Experimental
Arm Description
Monthly nutrition education sessions will be attended by the subjects and then each subject will receive a free nutrition box that includes recipes that pertain to the food contents in the prepackaged box
Intervention Type
Other
Intervention Name(s)
Food as medicine
Intervention Description
Encourage participants to make dietary changes by increasing consumption of nutritious foods, particularly fruits and vegetables. Reduce food insecurity by making it easier for participants to access nutritious foods to ensure they are eating a balanced diet. Increase nutrition literacy. Improve health-related outcomes of participants by decreasing chronic health conditions by decreasing health metrics using food as medicine.
Primary Outcome Measure Information:
Title
Blood Pressure - 3 month
Description
blood pressure will be collected
Time Frame
3 months
Title
Blood Pressure - 6 month
Description
blood pressure will be collected
Time Frame
6 months
Title
Blood Pressure - 9 month
Description
blood pressure will be collected
Time Frame
9 months
Title
Blood Pressure - 12 month
Description
blood pressure will be collected
Time Frame
12 months
Title
hemoglobin A1C - 3 month
Description
routine hemoglobin A1C will be determined
Time Frame
3 months
Title
hemoglobin A1C - 6 month
Description
routine hemoglobin A1C will be determined
Time Frame
6 months
Title
hemoglobin A1C - 9 month
Description
routine hemoglobin A1C will be determined
Time Frame
9 months
Title
hemoglobin A1C - 12 month
Description
routine hemoglobin A1C will be determined
Time Frame
12 months
Title
Total Cholesterol - 6 month
Description
total cholesterol will be determined from routine clinic visits
Time Frame
6 month
Title
Total Cholesterol - 12 month
Description
total cholesterol will be determined from routine clinic visits
Time Frame
12 month
Title
Body Weight - 3 month
Description
Body weigh in lbs will be collected at routine clinic visits
Time Frame
3 month
Title
Body Weight - 6 month
Description
Body weigh in lbs will be collected at routine clinic visits
Time Frame
6 month
Title
Body Weight - 9 month
Description
Body weigh in lbs will be collected at routine clinic visits
Time Frame
9 month
Title
Body Weight - 12 month
Description
Body weigh in lbs will be collected at routine clinic visits
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals, 18-years old and older Diagnosed with a chronic health morbidity such as hypertension, elevated A1C, hyperlipidemia and/or obesity. A patient at UAMS East Family Medical Center in Helena, Arkansas. Exclusion Criteria: Participants 17-years old and younger are excluded from The Good Food Rx program. Participants who are generally healthy and do not have chronic morbidities such hypertension, elevated A1C, hyperlipidemia and obesity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber K Norris, MD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS East - Helena
City
Helena
State/Province
Texas
ZIP/Postal Code
72390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Good Food Rx: Food-as-medicine Program

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