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Trial Title:
Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
NCT ID:
NCT06504914
Condition:
Hypertension
Obesity
Nutrition, Healthy
Conditions: Official terms:
Hypertension
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Assigned Interventions
Description:
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.
Arm group label:
Arms
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 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- self-identified as Black or of African descent
- female
- ≥ 18 years old
- baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Illinois Chicago
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
312-355-2125
Email:
slofto4@uic.edu
Start date:
February 5, 2024
Completion date:
January 2025
Lead sponsor:
Agency:
University of Illinois at Chicago
Agency class:
Other
Source:
University of Illinois at Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06504914
