Clinical trial NCT05541458: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Obesity
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
name: Well Fed
name: Arkansas Community Foundation
First posted: 2022-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Blood Pressure - 3 month
timeFrame: 3 months
measure: Blood Pressure - 6 month
timeFrame: 6 months
measure: Blood Pressure - 9 month
timeFrame: 9 months
measure: Blood Pressure - 12 month
timeFrame: 12 months
measure: hemoglobin A1C - 3 month
timeFrame: 3 months
measure: hemoglobin A1C - 6 month
timeFrame: 6 months
measure: hemoglobin A1C - 9 month
timeFrame: 9 months
measure: hemoglobin A1C - 12 month
timeFrame: 12 months
measure: Total Cholesterol - 6 month
timeFrame: 6 month
measure: Total Cholesterol - 12 month
timeFrame: 12 month
measure: Body Weight - 3 month
timeFrame: 3 month
measure: Body Weight - 6 month
timeFrame: 6 month
measure: Body Weight - 9 month
timeFrame: 9 month
measure: Body Weight - 12 month
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Helena
country: United States
facility: UAMS East - Helena
state: Texas
Study officials:
affiliation: UAMS
name: Amber K Norris, MD
role: PRINCIPAL_INVESTIGATOR
References: