Blood Pressure, Healthy Nutrition, Hypertension, Obesity
Conditions
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.
Interventions
BEHAVIORALRN-CHeFRx
The RN-CHeFRx trial to enhance dietary intake and blood pressure control in Black women with hypertension and obesity compared to usual care.
Sponsors
University of Chicago
Rush University
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the 12 week intervention | Up to 12 weeks | Completion will be measured by class attendance |
| Number of participants recruited | Up to 12 weeks | Patients recruited, screened, eligible and consented to participate in the study |
| 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 |
| Acceptability of the intervention | Up to 12 weeks | Assessed via participant feedback |
| 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 |
| dietary intake during intervention | Baseline to 12 weeks | Dietary intake at baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight during intervention | Up to 12 weeks | Change will be measured by comparing body weight obtained at baseline and 12 weeks |
| 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. |
| 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 |
| Dietary intake during post-intervention | 12 weeks to 24 weeks | Dietary intake from 12 weeks to 24 weeks |
Countries
United States
Outcome results
None listed