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Completed

NCT Number: NCT05796648

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

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.

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Key information

Conditions

Hypertension Blood Pressure Body Weight Cardiovascular Diseases Healthy Nutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RN-CHeFRx

Behavioral

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

Primary outcomes

  1. Number of participants who complete the 12 week intervention

    Time frame: Up to 12 weeks

    Completion will be measured by class attendance

  2. Number of participants recruited

    Time frame: Up to 12 weeks

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

  3. Number of participants who complete data collection visits

    Time frame: Baseline to 4 months

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

  4. Acceptability of the intervention

    Time frame: Up to 12 weeks

    Assessed via participant feedback

  5. Change in mean blood pressures (mmHg) during intervention

    Time frame: Baseline to 12 weeks

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

  6. dietary intake during intervention

    Time frame: Baseline to 12 weeks

    Dietary intake at baseline and 12 weeks

Secondary outcomes

  1. Change in body weight during intervention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 weeks to 24 weeks

    Dietary intake from 12 weeks to 24 weeks

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Rush University
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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