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Clinical Trials/NCT05541458
NCT05541458CompletedNot Applicable

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

University of Arkansas2 sites in 1 country20 target enrollmentStarted: September 13, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Blood Pressure - 3 month

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Blood Pressure - 3 month

Time Frame: 3 months

blood pressure will be collected

Blood Pressure - 12 month

Time Frame: 12 months

blood pressure will be collected

Blood Pressure - 6 month

Time Frame: 6 months

blood pressure will be collected

Blood Pressure - 9 month

Time Frame: 9 months

blood pressure will be collected

hemoglobin A1C - 3 month

Time Frame: 3 months

routine hemoglobin A1C will be determined

hemoglobin A1C - 9 month

Time Frame: 9 months

routine hemoglobin A1C will be determined

hemoglobin A1C - 12 month

Time Frame: 12 months

routine hemoglobin A1C will be determined

Body Weight - 3 month

Time Frame: 3 month

Body weigh in lbs will be collected at routine clinic visits

hemoglobin A1C - 6 month

Time Frame: 6 months

routine hemoglobin A1C will be determined

Total Cholesterol - 6 month

Time Frame: 6 month

total cholesterol will be determined from routine clinic visits

Total Cholesterol - 12 month

Time Frame: 12 month

total cholesterol will be determined from routine clinic visits

Body Weight - 6 month

Time Frame: 6 month

Body weigh in lbs will be collected at routine clinic visits

Body Weight - 12 month

Time Frame: 12 month

Body weigh in lbs will be collected at routine clinic visits

Body Weight - 9 month

Time Frame: 9 month

Body weigh in lbs will be collected at routine clinic visits

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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