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

Primary Purpose

Hypertension, Obesity, Healthy Nutrition

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RN-CHeFRx

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

University of Illinois Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Food is Medicine approach

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants who complete the 12 week intervention

Completion will be measured by class attendance

Number of participants recruited

Patients recruited, screened, eligible and consented to participate in the study

Number of participants who complete data collection visits

Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens

Acceptability of the intervention

Assessed via participant feedback

Change in mean blood pressures (mmHg) during intervention

Change will be measured by comparing blood pressures from baseline to 12 weeks

dietary intake during intervention

Dietary intake at baseline and 12 weeks

Secondary Outcome Measures

Change in body weight during intervention

Change will be measured by comparing body weight obtained at baseline and 12 weeks

Change in body weight at 6 months

Change will be measured by comparing body weight (kg) obtained at 12 weeks and at 24 weeks.

Change in blood pressure at 6 months

Change will be measured by comparing systolic and diastolic blood pressure at 12 weeks to 24 weeks

Dietary intake during post-intervention

Dietary intake from 12 weeks to 24 weeks

Full Information

NCT ID

NCT05796648

First Posted

December 13, 2022

Last Updated

September 27, 2023

Sponsor

University of Illinois at Chicago

Collaborators

University of Chicago, Rush University

1. Study Identification

Unique Protocol Identification Number

NCT05796648

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

Collaborators

University of Chicago, Rush University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Obesity, Healthy Nutrition, Blood Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Food is Medicine approach

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

RN-CHeFRx

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants who complete the 12 week intervention

Description

Completion will be measured by class attendance

Time Frame

Up to 12 weeks

Title

Number of participants recruited

Description

Patients recruited, screened, eligible and consented to participate in the study

Time Frame

Up to 12 weeks

Title

Number of participants who complete data collection visits

Description

Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens

Time Frame

Baseline to 4 months

Title

Acceptability of the intervention

Description

Assessed via participant feedback

Time Frame

Up to 12 weeks

Title

Change in mean blood pressures (mmHg) during intervention

Description

Change will be measured by comparing blood pressures from baseline to 12 weeks

Time Frame

Baseline to 12 weeks

Title

dietary intake during intervention

Description

Dietary intake at baseline and 12 weeks

Time Frame

Baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Change in body weight during intervention

Description

Change will be measured by comparing body weight obtained at baseline and 12 weeks

Time Frame

Up to 12 weeks

Title

Change in body weight at 6 months

Description

Change will be measured by comparing body weight (kg) obtained at 12 weeks and at 24 weeks.

Time Frame

12 weeks to 24 weeks

Title

Change in blood pressure at 6 months

Description

Change will be measured by comparing systolic and diastolic blood pressure at 12 weeks to 24 weeks

Time Frame

12 weeks to 24 weeks

Title

Dietary intake during post-intervention

Description

Dietary intake from 12 weeks to 24 weeks

Time Frame

12 weeks to 24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

University of Illinois Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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