The Good Food Rx: Food-as-medicine Program

Obesity Clinical Trial

Official title:

Alleviating Chronic Morbidities and Food Insecurity by Launching a Food-as-medicine Program Called: The Good Food Rx

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05541458
• Other study ID #: 274352
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: April 2026

Study information

• Verified date: October 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension
• Obesity

Intervention

Other:
• Food as medicine
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.

Locations

Country	Name	City	State
United States	UAMS East - Helena	Helena	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Arkansas	Arkansas Community Foundation, USDA Beltsville Human Nutrition Research Center, Well Fed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure - 3 month	blood pressure will be collected	3 months
Primary	Blood Pressure - 6 month	blood pressure will be collected	6 months
Primary	Blood Pressure - 9 month	blood pressure will be collected	9 months
Primary	Blood Pressure - 12 month	blood pressure will be collected	12 months
Primary	hemoglobin A1C - 3 month	routine hemoglobin A1C will be determined	3 months
Primary	hemoglobin A1C - 6 month	routine hemoglobin A1C will be determined	6 months
Primary	hemoglobin A1C - 9 month	routine hemoglobin A1C will be determined	9 months
Primary	hemoglobin A1C - 12 month	routine hemoglobin A1C will be determined	12 months
Primary	Total Cholesterol - 6 month	total cholesterol will be determined from routine clinic visits	6 month
Primary	Total Cholesterol - 12 month	total cholesterol will be determined from routine clinic visits	12 month
Primary	Body Weight - 3 month	Body weigh in lbs will be collected at routine clinic visits	3 month
Primary	Body Weight - 6 month	Body weigh in lbs will be collected at routine clinic visits	6 month
Primary	Body Weight - 9 month	Body weigh in lbs will be collected at routine clinic visits	9 month
Primary	Body Weight - 12 month	Body weigh in lbs will be collected at routine clinic visits	12 month