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

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05796648

Collaborator

University of Chicago (Other), Rush University (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Obesity Healthy Nutrition Blood Pressure	Behavioral: RN-CHeFRx	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants who complete the 12 week intervention [Up to 12 weeks]
Completion will be measured by class attendance
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
Acceptability of the intervention [Up to 12 weeks]
Assessed via participant feedback
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
dietary intake during intervention [Baseline to 12 weeks]
Dietary intake at baseline and 12 weeks

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Illinois at Chicago
University of Chicago
Rush University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saria Lofton, Assistant Professor, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT05796648

Other Study ID Numbers:

2022-0947

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Obesity

Study Results

No Results Posted as of Apr 4, 2023