Clinical trial NCT05796648: Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
Official title: Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Obesity
Healthy Nutrition
Blood Pressure
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Rush University
First posted: 2023-04-03
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who complete the 12 week intervention
timeFrame: Up to 12 weeks
measure: Number of participants recruited
timeFrame: Up to 12 weeks
measure: Number of participants who complete data collection visits
timeFrame: Baseline to 4 months
measure: Acceptability of the intervention
timeFrame: Up to 12 weeks
measure: Change in mean blood pressures (mmHg) during intervention
timeFrame: Baseline to 12 weeks
measure: dietary intake during intervention
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in body weight during intervention
timeFrame: Up to 12 weeks
measure: Change in body weight at 6 months
timeFrame: 12 weeks to 24 weeks
measure: Change in blood pressure at 6 months
timeFrame: 12 weeks to 24 weeks
measure: Dietary intake during post-intervention
timeFrame: 12 weeks to 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References: