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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Hypertension, Healthy Nutrition, Blood Pressure

Intervention / Treatment
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* Behavioral: RN-CHeFRx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food is Medicine approach<br>Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education. | Behavioral: RN-CHeFRx<br>* The RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete the 12 week intervention | Completion will be measured by class attendance | Up to 12 weeks | 
| Number of participants recruited | Patients recruited, screened, eligible and consented to participate in the study | Up to 12 weeks | 
| Number of participants who complete data collection visits | Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens | Baseline to 4 months | 
| Acceptability of the intervention | Assessed via participant feedback | Up to 12 weeks | 
| Change in mean blood pressures (mmHg) during intervention | Change will be measured by comparing blood pressures from baseline to 12 weeks | Baseline to 12 weeks | 
| dietary intake during intervention | Dietary intake at baseline and 12 weeks | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight during intervention | Change will be measured by comparing body weight obtained at baseline and 12 weeks | Up to 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. | 12 weeks to 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 | 12 weeks to 24 weeks | 
| Dietary intake during post-intervention | Dietary intake from 12 weeks to 24 weeks | 12 weeks to 24 weeks |