The Good Food Rx: Food-as-medicine Program

NCT05541458 | Completed

• 1 other identifier: 274352
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (14)

• Blood Pressure - 3 month

  blood pressure will be collected

  3 months

• Blood Pressure - 6 month

  blood pressure will be collected

  6 months

• Blood Pressure - 9 month

  blood pressure will be collected

  9 months

• Blood Pressure - 12 month

  blood pressure will be collected

  12 months

• hemoglobin A1C - 3 month

  routine hemoglobin A1C will be determined

  3 months

• hemoglobin A1C - 6 month

  routine hemoglobin A1C will be determined

  6 months

• hemoglobin A1C - 9 month

  routine hemoglobin A1C will be determined

  9 months

• hemoglobin A1C - 12 month

  routine hemoglobin A1C will be determined

  12 months

• Total Cholesterol - 6 month

  total cholesterol will be determined from routine clinic visits

  6 month

• Total Cholesterol - 12 month

  total cholesterol will be determined from routine clinic visits

  12 month

• Body Weight - 3 month

  Body weigh in lbs will be collected at routine clinic visits

  3 month

• Body Weight - 6 month

  Body weigh in lbs will be collected at routine clinic visits

  6 month

• Body Weight - 9 month

  Body weigh in lbs will be collected at routine clinic visits

  9 month

• Body Weight - 12 month

  Body weigh in lbs will be collected at routine clinic visits

  12 month

Study Arms (1)

Educational sessions plus a nutrition box and recipes

EXPERIMENTAL

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

Other: Food as medicine

Interventions

Food as medicine OTHER

* 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.

Educational sessions plus a nutrition box and recipes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• USDA Beltsville Human Nutrition Research Center: collaborator
• Well Fed: collaborator
• Arkansas Community Foundation: collaborator

Study Sites (1)

UAMS East - Helena

Helena, Texas, 72390, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Obesity

Interventions

Food; Dosage Forms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Amber K Norris, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: September 13, 2022
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-09

Locations

US (1)