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

ClinicalTrials.gov processed this data on September 27, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified September 2023 by University of Illinois at Chicago, University of Chicago, Rush University

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 13, 2022
First Posted: April 3, 2023
Last Update Posted: September 28, 2023
Last Verified: September 2023
History of Changes

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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 Disease Intervention/Treatment
  • Hypertension
  • Obesity
  • Healthy Nutrition
  • Blood Pressure
  • Behavioral: RN-CHeFRx

Study Design

Study TypeInterventional
Anticipated Enrollment24 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 DateJune 1, 2023
Anticipated Primary Completion DateSeptember 30, 2023
Anticipated Study Completion DateDecember 31, 2023

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 [Up to 12 weeks]
    Completion will be measured by class attendance
  2. Number of participants recruited [Up to 12 weeks]
    Patients recruited, screened, eligible and consented to participate in the study
  3. 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
  4. Acceptability of the intervention [Up to 12 weeks]
    Assessed via participant feedback
  5. 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
  6. dietary intake during intervention [Baseline to 12 weeks]
    Dietary intake at baseline and 12 weeks

Secondary Outcome Measures

  1. Change in body weight during intervention [Up to 12 weeks]
    Change will be measured by comparing body weight obtained at baseline and 12 weeks
  2. 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.
  3. 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
  4. Dietary intake during post-intervention [12 weeks to 24 weeks]
    Dietary intake from 12 weeks to 24 weeks

Eligibility Criteria

Ages Eligible for Study 18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study Female
Accepts Healthy Volunteers No
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 Collaborators University of Illinois at Chicago, University of Chicago, Rush University
University of Chicago, Rush University
Locations
  • University of Illinois Chicago | Chicago, Illinois, United States, 60612

More Information

Additional Relevant MeSH Terms

  • Hypertension
  • Obesity
  • Overweight
  • Overnutrition
  • Nutrition Disorders
  • Body Weight
  • Vascular Diseases
  • Cardiovascular Diseases