Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Blood Pressure; Healthy Nutrition
• Intervention / Treatment: Behavioral: RN-CHeFRx

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
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food is Medicine approach; Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete the 12 week intervention	Completion will be measured by class attendance	Up to 12 weeks
Number of participants recruited	Patients recruited, screened, eligible and consented to participate in the study	Up to 12 weeks
Number of participants who complete data collection visits	Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens	Baseline to 4 months
Acceptability of the intervention	Assessed via participant feedback	Up to 12 weeks
Change in mean blood pressures (mmHg) during intervention	Change will be measured by comparing blood pressures from baseline to 12 weeks	Baseline to 12 weeks
dietary intake during intervention	Dietary intake at baseline and 12 weeks	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight during intervention	Change will be measured by comparing body weight obtained at baseline and 12 weeks	Up to 12 weeks
Change in body weight at 6 months	Change will be measured by comparing body weight (kg) obtained at 12 weeks and at 24 weeks.	12 weeks to 24 weeks
Change in blood pressure at 6 months	Change will be measured by comparing systolic and diastolic blood pressure at 12 weeks to 24 weeks	12 weeks to 24 weeks
Dietary intake during post-intervention	Dietary intake from 12 weeks to 24 weeks	12 weeks to 24 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: University of Chicago; Rush University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: April 1, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Hypertension
• Other Study ID Numbers: 2022-0947; P50MD017349 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No