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Clinical Trials/NCT05796648
NCT05796648
Completed
Not Applicable

Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity

University of Illinois at Chicago1 site in 1 country18 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Illinois at Chicago
Enrollment
18
Locations
1
Primary Endpoint
Number of participants who complete the 12 week intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
February 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saria Lofton

Assistant Professor

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

  • self-identified as Black or of African descent
  • ≥ 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

Outcomes

Primary Outcomes

Number of participants who complete the 12 week intervention

Time Frame: Up to 12 weeks

Completion will be measured by class attendance

Acceptability of the intervention

Time Frame: Up to 12 weeks

Assessed via participant feedback

dietary intake during intervention

Time Frame: Baseline to 12 weeks

Dietary intake at baseline and 12 weeks

Number of participants recruited

Time Frame: Up to 12 weeks

Patients recruited, screened, eligible and consented to participate in the study

Number of participants who complete data collection visits

Time Frame: Baseline to 4 months

Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens

Change in mean blood pressures (mmHg) during intervention

Time Frame: Baseline to 12 weeks

Change will be measured by comparing blood pressures from baseline to 12 weeks

Secondary Outcomes

  • Change in body weight during intervention(Up to 12 weeks)
  • Change in body weight at 6 months(12 weeks to 24 weeks)
  • Change in blood pressure at 6 months(12 weeks to 24 weeks)
  • Dietary intake during post-intervention(12 weeks to 24 weeks)

Study Sites (1)

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