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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 2024 by University of Illinois at Chicago
Sponsor
University of Illinois at Chicago
Information Provided by (Responsible Party)
Saria Lofton
Clinicaltrials.gov Identifier
NCT05796648
Other Study ID Numbers:
2022-0947
First Submitted
December 12, 2022
First Posted
April 2, 2023
Last Update Posted
January 7, 2025
Last Verified
October 2024

ClinicalTrials.gov processed this data on January 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
HypertensionObesityHealthy NutritionBlood Pressure
Behavioral: RN-CHeFRx

Study Design

Study TypeInterventional
Actual Enrollment18 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitlePreparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity
Study Start DateMay 31, 2023
Actual Primary Completion DateFebruary 14, 2024
Actual Study Completion DateFebruary 14, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
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
  1. Number of participants who complete the 12 week intervention
    Completion will be measured by class attendance
  2. Number of participants recruited
    Patients recruited, screened, eligible and consented to participate in the study
  3. Number of participants who complete data collection visits
    Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens
  4. Acceptability of the intervention
    Assessed via participant feedback
  5. Change in mean blood pressures (mmHg) during intervention
    Change will be measured by comparing blood pressures from baseline to 12 weeks
  6. dietary intake during intervention
    Dietary intake at baseline and 12 weeks
Secondary Outcome Measures
  1. Change in body weight during intervention
    Change will be measured by comparing body weight obtained at baseline and 12 weeks
  2. Change in body weight at 6 months
    Change will be measured by comparing body weight (kg) obtained at 12 weeks and at 24 weeks.
  3. Change in blood pressure at 6 months
    Change will be measured by comparing systolic and diastolic blood pressure at 12 weeks to 24 weeks
  4. Dietary intake during post-intervention
    Dietary intake from 12 weeks to 24 weeks

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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

Sponsors and CollaboratorsUniversity of Illinois at Chicago
Locations
University of Illinois Chicago | Chicago Illinois, United States, 60612