HypertensionNCT05541458
The Good Food Rx: Food-as-medicine Program
A study testing Food as medicine in people with Hypertension and Diabetes Mellitus, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Obesity
- What is being tested?
- Food as medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 21 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alleviating Chronic Morbidities and Food Insecurity by Launching a Food-as-medicine Program Called: The Good Food Rx
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.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitus, Obesity
- Being tested
- Food as medicine
- Medical subject headings
- Hypertension, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food as medicineOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Food as medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure - 3 month
blood pressure will be collected
Measured: 3 months
Blood Pressure - 6 month
blood pressure will be collected
Measured: 6 months
Blood Pressure - 9 month
blood pressure will be collected
Measured: 9 months
Blood Pressure - 12 month
blood pressure will be collected
Measured: 12 months
hemoglobin A1C - 3 month
routine hemoglobin A1C will be determined
Measured: 3 months
hemoglobin A1C - 6 month
routine hemoglobin A1C will be determined
Measured: 6 months
hemoglobin A1C - 9 month
routine hemoglobin A1C will be determined
Measured: 9 months
hemoglobin A1C - 12 month
routine hemoglobin A1C will be determined
Measured: 12 months
Total Cholesterol - 6 month
total cholesterol will be determined from routine clinic visits
Measured: 6 month
Total Cholesterol - 12 month
total cholesterol will be determined from routine clinic visits
Measured: 12 month
Body Weight - 3 month
Body weigh in lbs will be collected at routine clinic visits
Measured: 3 month
Body Weight - 6 month
Body weigh in lbs will be collected at routine clinic visits
Measured: 6 month
Body Weight - 9 month
Body weigh in lbs will be collected at routine clinic visits
Measured: 9 month
Body Weight - 12 month
Body weigh in lbs will be collected at routine clinic visits
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start13 Sep 2022
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center, Well Fed, Arkansas Community Foundation
- Responsible party
- Sponsor
- Investigators
- Amber K Norris, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541458
- Sponsor's protocol ID
- 274352
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Chronic Morbidities and Food Insecurity by Launching a Food-as-medicine Program Called: The Good Food Rx
- ClinicalTrials.gov ID
- NCT05541458
- Acronym / sponsor ID
- 274352
- Conditions
- Hypertension, Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center, Well Fed, Arkansas Community Foundation
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational sessions plus a nutrition box and recipes | Experimental | Other: Food as medicineMonthly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Educational sessions plus a nutrition box and recipes |
Primary outcome
Blood Pressure - 3 month
Time frame: 3 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
Blood Pressure - 12 month
Time frame: 12 months
blood pressure will be collected
hemoglobin A1C - 3 month
Time frame: 3 months
routine hemoglobin A1C will be determined
hemoglobin A1C - 6 month
Time frame: 6 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
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 - 3 month
Time frame: 3 month
Body weigh in lbs will be collected at routine clinic visits
Body Weight - 6 month
Time frame: 6 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
Body Weight - 12 month
Time frame: 12 month
Body weigh in lbs will be collected at routine clinic visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber K Norris, MD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food as medicine in people with Hypertension and Diabetes Mellitus, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure - 3 month (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.