HypertensionNCT05926193
Food as Medicine Project
A study testing Tailor Food Bags in people with Hypertension, run by Duke University at 1 site in United States.
Trial summary
Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Tailor Food Bags
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 30 Aug 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult parent/legal guardian (age 18 or older)
- Documented essential hypertension (systolic BP >140 and/or diastolic BP >90, at least two documented clinical measurements)
- Self-reported African American or Latino
Who cannot join
- Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)
- Homelessness or insecure/transitional housing
- Inability to prepare or cook food for themselves
- Participants not living in Durham County, N.C.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arraigados Juntos - Rooted Together, Food as Medicine Project
Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond.
- Conditions
- Hypertension
- Being tested
- Tailor Food Bags
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailor Food BagsDietary supplement
Also called Nutrition Workshops
The treatment group will participate in 6 nutrition workshops over the course of 6 months as well as receive weekly food bags that have been tailored for a DASH diet.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Workshops | Experimental | Not described Receives: Dietary Supplement: Tailor Food Bags |
| No Workshops | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Systolic and diastolic BP will be documented at end of visit
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (1)
Patient satisfaction with culturally relevant foods
Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start30 Mar 2023
- Primary completion29 Jul 2023
- Study completion30 Aug 2023
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 Duke UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926193
- Sponsor's protocol ID
- Pro00111072
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arraigados Juntos - Rooted Together, Food as Medicine Project
- ClinicalTrials.gov ID
- NCT05926193
- Acronym / sponsor ID
- Pro00111072
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 3 Jul 2023 (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.
Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Workshops | Experimental | Dietary Supplement: Tailor Food Bags |
| No Workshops | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult parent/legal guardian (age 18 or older)
- Documented essential hypertension (systolic BP >140 and/or diastolic BP >90, at least two documented clinical measurements)
- Self-reported African American or Latino
Key exclusion criteria (5 listed)
- Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)
- Homelessness or insecure/transitional housing
- Inability to prepare or cook food for themselves
- Participants not living in Durham County, N.C.
- Pregnant women
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 |
|---|---|---|
| Tailor Food BagsAlso: Nutrition WorkshopsThe treatment group will participate in 6 nutrition workshops over the course of 6 months as well as receive weekly food bags that have been tailored for a DASH diet. | Dietary supplement | Nutrition Workshops |
Primary outcome
Change in blood pressure
Time frame: Baseline, 6 weeks, 12 weeks
Systolic and diastolic BP will be documented at end of visit
1 secondary outcome
Patient satisfaction with culturally relevant foods
Time frame: 12 weeks
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 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailor Food Bags in people with Hypertension, run by Duke University 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 5 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 22 Sep 2023. 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?
Change in blood pressure (time frame: Baseline, 6 weeks, 12 weeks). 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 22 Sep 2023.