Lifestyle Modification for High Blood Pressure and Obesity

(FIM-BCS Trial)

Overseen By Saria Lofton

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cancer, Liver disease, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Black women with both high blood pressure (hypertension) and obesity by enhancing their eating habits and better managing blood pressure. It features a 12-week program with cooking classes, grocery deliveries, and nutrition lessons. The trial incorporates RN-CHeFRx, a lifestyle modification program. It targets Black women with high blood pressure and a body mass index (BMI, a measure of body fat) of 30 or more. Participants should be able to cook at home and not have certain health conditions, such as cancer or liver disease. As an unphased trial, this study provides a unique opportunity for personalized lifestyle changes to improve health.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RN-CHeFRx intervention is safe for participants?

Research has shown that the RN-CHeFRx program, which includes cooking classes, grocery delivery, and nutrition education, aims to improve diet and lifestyle. Although specific safety data for RN-CHeFRx is unavailable, similar programs are generally safe. They involve everyday activities like cooking and food delivery, which are not known to cause harm.

In similar studies, participants did not experience serious problems from lifestyle changes like eating healthier. This program does not include drugs or medical procedures, which typically have more safety concerns. Prospective participants can expect activities that are part of daily life, designed to help manage blood pressure and weight through better eating habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RN-CHeFRx treatment because it takes a "Food is Medicine" approach to tackle high blood pressure and obesity, which is quite different from traditional medication or lifestyle advice. Instead of focusing solely on pills or restrictive diets, RN-CHeFRx involves interactive cooking classes, providing grocery deliveries, and offering nutrition education. This hands-on, educational method empowers participants to make healthier choices and maintain these lifestyle changes long-term, which is a fresh take on managing these conditions.

What evidence suggests that the RN-CHeFRx intervention could be effective for hypertension and obesity?

Research has shown that nurse-led care can help manage high blood pressure in the short term. One study found that this care lowered the systolic blood pressure compared to regular care. Additionally, losing even a small amount of weight can help maintain lower blood pressure over time for those who are overweight. Obesity is closely linked to a higher risk of high blood pressure and related health issues. Overall, these findings suggest that the RN-CHeFRx program, which includes cooking classes, grocery delivery, and nutrition education, could effectively improve blood pressure and eating habits in Black women with high blood pressure and obesity. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for African-American breast cancer survivors who are dealing with obesity and high blood pressure. It aims to help them improve their eating habits and manage blood pressure through a 12-week program involving grocery delivery, cooking classes, and nutrition education.

Inclusion Criteria

Self-identified as Black or of African descent

I am female.

My blood pressure is high or I have hypertension and my BMI is 30 or more.

Exclusion Criteria

Lack of English language proficiency

I have a history of liver or kidney disease.

I cannot cook in my home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the RN-CHeFRx intervention, which includes grocery delivery, cooking classes, and nutrition education

12 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 12 weeks, and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• RN-CHeFRx

Trial Overview The RN-CHeFRx intervention being tested includes three components: the delivery of groceries to participants' homes, cooking classes designed to teach healthy meal preparation, and educational sessions on nutrition. The goal is to see if this approach is practical and well-received by the participants.

How Is the Trial Designed?

Group I: Arms Experimental Treatment 1 Intervention

Participants will attend a 8 week intervention that includes cooking classes, grocery delivery and nutrition education.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101864/

Therapeutic Considerations in the Treatment of Obesity ... Controlled clinical trials of weight reduction have shown that hypertensive subjects who have lost weight but regained the weight over time maintain lower blood ...

2. nursingcenter.com nursingcenter.com/cearticle?an=00006205-202306000-00003&Journal_ID=54012&Issue_ID=6690539

Obesity-related hypertension: Implications for advanced ... Obesity is associated with an increased risk of developing hypertension (HTN) and other complications such as type 2 diabetes mellitus (T2DM), dyslipidemia, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056068/

The short and long-term efficacy of nurse-led interventions for ... Previous systematic reviews suggest that nurse-led interventions improve short-term blood pressure (BP) control for people with hypertension.

4. academic.oup.com academic.oup.com/eurjcn/article/23/1/21/7148296

Effectiveness of nurse-led interventions versus usual care to ... Effect on systolic blood pressure ... Based on pooled data, at 6 months or less, nurse-led care may reduce SBP compared with usual care (MD −6.48; ...

5. arch.astate.edu arch.astate.edu/cgi/viewcontent.cgi?article=1056&context=dnp-projects

Weight Loss and the Effects on Blood Pressure This DNP project will impact patients who are overweight and obese and have the potential to affect outcomes of those with elevated blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8972110/

Blood Pressure Control in Individuals With Hypertension ... This study aims to evaluate characteristics of participants with stage 2 hypertension who used Foodsmart and to assess changes in systolic blood pressure (SBP) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S266726852500018X

The consumption of fast food and obesity associated with ... This study's primary objective is to investigate how fast-food intake, portion size, obesity, and hypertension are related among Amman, Jordan, restaurant ...

8. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.22341

Ultra-Processed Food Consumption and Hypertension ... This study demonstrated that high consumption of UPF is associated with increased hypertension risk.

9. clinicalnutritionopenscience.com clinicalnutritionopenscience.com/article/S2667-2685(25)00018-X/pdf

The consumption of fast food and obesity associated with ... Participants' blood pressure level readings are categorized and shown in Table 2, 82 percent (n = 316) of the 386 individuals had normal blood ...