Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Nutrition, Healthy; Hypertension; Obesity
• Interventions: Behavioral: Assigned Interventions

• Registration Number: NCT06504914
• Lead Sponsor: University of Illinois at Chicago

Brief 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

Study Timeline

• Study Start: 2024-02-05
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-11
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arms	Assigned Interventions	Food is Medicine approach Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education.

Primary Outcome Measures

Name	Time	Method
Number of participants who complete the 12 week intervention	[Time Frame: Up to 12 weeks]	Completion will be measured by class attendance

Trial Locations

Locations (1)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States