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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD017961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The goal of this clinical trial is to determine the impact of a home-delivered foods and kitchen skills program on health and nutrition in adults with high blood pressure and food insecurity.
Researchers will compare Food Resources & Kitchen Skills (FoRKS) and Enhanced Usual Care (EUC) to evaluate the effects on mean systolic blood pressure (SPB), HbA1c, food security and nutrition.
Participants will complete 24-hr blood pressure monitoring, standard blood pressure measurements, weight, finger stick for A1c point-of-care testing, and questionnaires.
This behavioral randomized controlled trial will evaluate nutritious food delivery and cooking classes (FoRKS) versus enhanced usual care (EUC) in adults with food insecurity and systolic blood pressure of ≥120 mm Hg. This project seeks to evaluate the potential for hands-on training in food management skills to create lasting improvements in food security, self-efficacy, nutrition, and risk factor reduction in persons with prevalent chronic disease.
Adults who pass the telephone screen will be invited to complete a blood pressure check for final eligibility determination. Participants must receive an average systolic read of ≥120 mmHG across 3 standard BP readings with designated wait periods; a maximum of 5 readings may be attempted to receive 3 successful measurements necessary to calculate the average. Participants who meet criteria and give informed consent will complete a full baseline assessment consisting of questionnaires, finger stick for A1c point-of-care testing, weight, and 24-hour ambulatory blood pressure before randomization to one of two arms:
Assessments will be completed around Week 16 as the primary endpoint, and around Week 24 for maintenance evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care (EUC) | Active Comparator | Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex. |
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| Food Resources & Kitchen Skills (FoRKS) | Experimental | Participants randomized to FoRKS will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS intervention. Following HTN SMES completion, FoRKS continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Resources & Kitchen Skills (FoRKS) | Behavioral | Food Resources & Kitchen Skills (FoRKS) includes 5 weeks of hypertension classes followed by 11 weeks of home-delivered Mediterranean-style ingredient kits and virtual cooking classes with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel O Clark, PhD | Contact | 317-274-9292 | daniclar@iu.edu | |
| Lyndsi R Moser, BA, CCRP | Contact | 317-963-7301 | lrhabegg@iupui.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel O Clark, PhD | Indiana University | Principal Investigator |
| Richard Holden, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Enhanced Usual Care (EUC) | Behavioral | Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes. |
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