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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05796648
• Other study ID #: 2022-0947
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Rush University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete the 12 week intervention	Completion will be measured by class attendance	Up to 12 weeks
Primary	Number of participants recruited	Patients recruited, screened, eligible and consented to participate in the study	Up to 12 weeks
Primary	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
Primary	Acceptability of the intervention	Assessed via participant feedback	Up to 12 weeks
Primary	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
Primary	dietary intake during intervention	Dietary intake at baseline and 12 weeks	Baseline to 12 weeks
Secondary	Change in body weight during intervention	Change will be measured by comparing body weight obtained at baseline and 12 weeks	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	Dietary intake during post-intervention	Dietary intake from 12 weeks to 24 weeks	12 weeks to 24 weeks