HypertensionNCT05796648
Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
A study testing RN-CHeFRx in people with Hypertension and Obesity, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Hypertension, Obesity, Healthy Nutrition
- What is being tested?
- RN-CHeFRx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 15 Feb 2024
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identified as Black or of African descent
- female
- ≥ 18 years old
- baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30
Who cannot join
- inability to cook in their homes
- cognitive deficits impeding the ability to participate or provide informed consent
- current treatment for cancer
- liver or renal disease
- pregnancy
- lack of English language proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
Read the detailed description
The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity.
- Conditions
- Hypertension, Obesity, Healthy Nutrition, Blood Pressure
- Being tested
- RN-CHeFRx
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN-CHeFRxBehavioural
The RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Food is Medicine approach | Experimental | Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education. Receives: Behavioral: RN-CHeFRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the 12 week intervention
Completion will be measured by class attendance
Measured: Up to 12 weeks
Number of participants recruited
Patients recruited, screened, eligible and consented to participate in the study
Measured: Up to 12 weeks
Number of participants who complete data collection visits
Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens
Measured: Baseline to 4 months
Acceptability of the intervention
Assessed via participant feedback
Measured: Up to 12 weeks
Change in mean blood pressures (mmHg) during intervention
Change will be measured by comparing blood pressures from baseline to 12 weeks
Measured: Baseline to 12 weeks
dietary intake during intervention
Dietary intake at baseline and 12 weeks
Measured: Baseline to 12 weeks
Secondary outcomes (4)
Change in body weight during intervention
Change will be measured by comparing body weight obtained at baseline and 12 weeks
Measured: Up to 12 weeks
Change in body weight at 6 months
Change will be measured by comparing body weight (kg) obtained at 12 weeks and at 24 weeks.
Measured: 12 weeks to 24 weeks
Change in blood pressure at 6 months
Change will be measured by comparing systolic and diastolic blood pressure at 12 weeks to 24 weeks
Measured: 12 weeks to 24 weeks
Dietary intake during post-intervention
Dietary intake from 12 weeks to 24 weeks
Measured: 12 weeks to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jun 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
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 Illinois ChicagoThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Rush University
- Responsible party
- Principal investigator, Saria Lofton, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796648
- Sponsor's protocol ID
- 2022-0947
- Other IDs
- P50MD017349
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity
- ClinicalTrials.gov ID
- NCT05796648
- Acronym / sponsor ID
- 2022-0947
- Conditions
- Hypertension, Obesity, Healthy Nutrition, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Chicago, Rush University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 3 Apr 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.
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention - grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
Detailed description
The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food is Medicine approach | Experimental | Behavioral: RN-CHeFRxGroups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-identified as Black or of African descent
- female
- ≥ 18 years old
- baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30
Key exclusion criteria (6 listed)
- inability to cook in their homes
- cognitive deficits impeding the ability to participate or provide informed consent
- current treatment for cancer
- liver or renal disease
- pregnancy
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 |
|---|---|---|
| RN-CHeFRxThe RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care. | Behavioural | Food is Medicine approach |
Primary outcome
Number of participants who complete the 12 week intervention
Time frame: Up to 12 weeks
Completion will be measured by class attendance
Number of participants recruited
Time frame: Up to 12 weeks
Patients recruited, screened, eligible and consented to participate in the study
Number of participants who complete data collection visits
Time frame: Baseline to 4 months
Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens
Acceptability of the intervention
Time frame: Up to 12 weeks
Assessed via participant feedback
Change in mean blood pressures (mmHg) during intervention
Time frame: Baseline to 12 weeks
Change will be measured by comparing blood pressures from baseline to 12 weeks
dietary intake during intervention
Time frame: Baseline to 12 weeks
Dietary intake at baseline and 12 weeks
4 secondary outcomes
Change in body weight during intervention
Time frame: Up to 12 weeks
Change in body weight at 6 months
Time frame: 12 weeks to 24 weeks
Change in blood pressure at 6 months
Time frame: 12 weeks to 24 weeks
Dietary intake during post-intervention
Time frame: 12 weeks to 24 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 8 Jan 2025.
- 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 RN-CHeFRx in people with Hypertension and Obesity, run by University of Illinois Chicago 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 4 inclusion and 6 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 8 Jan 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?
Number of participants who complete the 12 week intervention (time frame: Up to 12 weeks). The study lists 6 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 8 Jan 2025.