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

Not Applicable

Completed

• Conditions: Hypertension; Healthy Nutrition; Blood Pressure; Obesity
• Interventions: Behavioral: RN-CHeFRx

• Registration Number: NCT05796648
• 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 First Submitted: 2022-12-13
• Study First Submitted QC: 2023-04-01
• Study First Posted: 2023-04-03
• Study Start: 2023-06-01
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Food is Medicine approach	RN-CHeFRx	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	Up to 12 weeks	Completion will be measured by class attendance
Acceptability of the intervention	Up to 12 weeks	Assessed via participant feedback
dietary intake during intervention	Baseline to 12 weeks	Dietary intake at baseline and 12 weeks
Number of participants recruited	Up to 12 weeks	Patients recruited, screened, eligible and consented to participate in the study
Number of participants who complete data collection visits	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	Baseline to 12 weeks	Change will be measured by comparing blood pressures from baseline to 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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