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

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University of Illinois

Status

Enrolling

Conditions

Hypertension
Obesity
Nutrition, Healthy

Treatments

Behavioral: Assigned Interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT06504914
2022-0966

Details and patient eligibility

About

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.

Full 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

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Arms
Experimental group
Description:
Participants will attend a 8 week intervention that includes cooking classes, grocery delivery and nutrition education.
Treatment:
Behavioral: Assigned Interventions

Trial contacts and locations

1

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Central trial contact

Saria Lofton

Data sourced from clinicaltrials.gov

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