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

NCT ID: NCT05796648

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-15

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.

Conditions

Hypertension; Obesity; Healthy Nutrition; Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Food is Medicine approach

Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education.

Group Type: EXPERIMENTAL

RN-CHeFRx

Intervention Type: BEHAVIORAL

The RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

Rush University

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Saria Lofton

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

P50MD017349

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-0947

Identifier Type: -

Identifier Source: org_study_id