HypertensionFIM-BCSNCT06504914
Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
A study testing Assigned Interventions 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, Nutrition, Healthy
- What is being tested?
- Assigned Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 Jun 2026
- 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/or BMI ≥ 25 - > 6 months post active cancer treatment
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: Developing FIM-BCS: A Lifestyle Modification for African-American Breast Cancer Survivors With Cardiovascular Risk Factors
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, Nutrition, Healthy
- Being tested
- Assigned Interventions
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsBehavioural
Behavioral: RN-CHeFRx 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 |
|---|---|---|
| Arms | Experimental | Participants will attend a 8 week intervention that includes cooking classes, grocery delivery and nutrition education. Receives: Behavioral: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the 8 week intervention
Completion will be measured by class attendance
Measured: [Time Frame: Up to 8 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start5 Feb 2024
- Primary completion1 May 2026
- Study completion1 Jun 2026
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504914
- Sponsor's protocol ID
- 2022-0966
- Acronym
- FIM-BCS
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2024
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing FIM-BCS: A Lifestyle Modification for African-American Breast Cancer Survivors With Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT06504914
- Acronym / sponsor ID
- FIM-BCS / 2022-0966
- Conditions
- Hypertension, Obesity, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 17 Jul 2024 (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 |
|---|---|---|
| Arms | Experimental | Behavioral: Assigned InterventionsParticipants will attend a 8 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/or BMI ≥ 25 - > 6 months post active cancer treatment
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 |
|---|---|---|
| Assigned InterventionsBehavioral: RN-CHeFRx The RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care. | Behavioural | Arms |
Primary outcome
Number of participants who complete the 8 week intervention
Time frame: [Time Frame: Up to 8 weeks]
Completion will be measured by class attendance
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 9 Oct 2026.
- 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 Assigned Interventions 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 9 Oct 2026. 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 8 week intervention (time frame: [Time Frame: Up to 8 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 9 Oct 2026.