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NCT06504914 | RECRUITING | Hypertension


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

Condition or disease

Hypertension

Obesity

Nutrition, Healthy

Intervention/treatment

Assigned Interventions

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Masking Description : None (Open Label)
Primary Purpose : TREATMENT
Official Title : Developing FIM-BCS: A Lifestyle Modification for African-American Breast Cancer Survivors With Cardiovascular Risk Factors
Actual Study Start Date : 2024-02-05
Estimated Primary Completion Date : 2024-11
Estimated Study Completion Date : 2025-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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

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

Location Details

NCT06504914


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Locations


RECRUITING

United States, Illinois

University of Illinois Chicago

Chicago, Illinois, United States, 60612

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