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

NCT05796648 | Completed

• 2 other identifiers: 2022-0947P50MD017349
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obesity; Healthy Nutrition; Blood Pressure

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change in body weight during intervention

  Up to 12 weeks

• Change in body weight at 6 months

  12 weeks to 24 weeks

• Change in blood pressure at 6 months

  12 weeks to 24 weeks

• Dietary intake during post-intervention

  12 weeks to 24 weeks

Study Arms (1)

Food is Medicine approach

EXPERIMENTAL

Groups of 10 will attend a 12 week intervention that includes cooking classes, grocery delivery and nutrition education.

Behavioral: RN-CHeFRx

Interventions

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.

Food is Medicine approach

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identified as Black or of African descent
• female
• ≥ 18 years old
• baseline blood pressure ≥130/85 or diagnosed with hypertension and BMI ≥ 30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Chicago: collaborator
• Rush University: collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: April 3, 2023
• Study Start: June 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: January 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)