Preparing a Food Is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women With Hypertension and Obesity
ClinicalTrials.gov processed this data on July 29, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified July 2024 by University of Illinois at Chicago, University of Chicago, Rush University
Sponsor
University of Illinois at ChicagoInformation Provided by (Responsible Party)
Saria LoftonClinicaltrials.gov Identifier
NCT05796648Other Study ID Numbers: 2022-0947
First Submitted: December 13, 2022
First Posted: April 3, 2023
Last Update Posted: July 30, 2024
Last Verified: July 2024
History of Changes
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Study 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.| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 18 participants |
| Design Allocation | N/A |
| Interventional Model | Single Group Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | Preparing a Food Is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women With Hypertension and Obesity |
| Study Start Date | June 1, 2023 |
| Actual Primary Completion Date | September 30, 2023 |
| Actual Study Completion Date | February 15, 2024 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 99 Years (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | University of Illinois at Chicago, University of Chicago, Rush University |
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| University of Chicago, Rush University | |
| Locations |
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More Information
Additional Relevant MeSH Terms
- Hypertension
- Obesity
- Overweight
- Overnutrition
- Nutrition Disorders
- Body Weight
- Vascular Diseases
- Cardiovascular Diseases