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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05796648
Other study ID # 2022-0947
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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