NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions

African Americans have higher rates of diabetes, obesity, heart disease, and high blood pressure. In addition, middle-aged non-Hispanic Black adults develop multiple chronic conditions (MCCs) at an earlier age, which share most of the same risk factors, including poor diet and physical inactivity. The major goal of the proposed project is to develop a culturally tailored intervention focused on improving awareness, knowledge, diet quality, and physical activity in a cohort of AA adults with MCCs.

Study Overview

• Status: Completed
• Conditions: Hypertension; Type 2 Diabetes; Heart Disease; Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Behavioral: Nutrition Matters

Detailed Description

Chronic diseases and their risk factors are more common and severe for African Americans (AAs) and other racial and ethnic minority groups. The CDC reports that non-Hispanic Blacks are 30% more likely to have high blood pressure and twice as likely as White adults to be diagnosed with diabetes and heart disease or suffer a stroke. In addition, middle-aged non-Hispanic Black adults have higher levels of chronic disease burden and develop multiple chronic conditions (MCCs) at an earlier age. Since chronic diseases share most of the same risk factors, including poor diet and physical inactivity, the inherent potential exists for prevention. Food is Medicine refers to a spectrum of services and health interventions that recognize and respond to the critical link between nutrition and chronic illness. By addressing nutritional needs within the context of health care, Food is Medicine interventions play an important role in preventing and/or managing many of the chronic conditions that drive health care costs. In addition, social support is a key factor influencing health behavior change and aids in successful weight loss, weight management, and obesity program adherence. Thus, this project proposes to pilot a 12-week Food is Medicine intervention with a 3-month follow-up to improve awareness, knowledge, and healthy lifestyle behaviors - primarily nutrition and physical activity in a cohort of AA adults with MCCs. The proposed project will focus on health equity in that it will include nutrition education, interactive cooking demonstrations, the provision of healthy food, and organized walking groups necessary for improved rates of behavior change and the formation of new habits. The proposed project aims to improve physical activity and dietary intakes that influence diabetes, high blood pressure (directly linked to kidney health), and cardiovascular health that disproportionately affect the AA community.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27110
      • Winston-Salem State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• African American
• Age 35-64 years old
• must have been diagnosed with pre diabetes or diabetes and have one other diagnosed chronic condition, including obesity (BMI >35), hypertension, and heart disease.

Exclusion Criteria:

• Individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Church Group; Participants recruited from a church congregation were enrolled in this group.	Behavioral: Nutrition Matters; The intervention will consist of two components: educational sessions and a structured PA component. The primary purpose of the educational sessions is to increase experimental group participants' scientific knowledge and skills in healthy cooking and eating. NUTRITION-MATTERS includes weekly 1.5-hour education sessions for a total of 12 weeks. The sessions will be sequenced carefully to blend brief lectures by experts, experience sharing by participants, and an interactive cooking demonstration. All participants will be provided with $20 of food that corresponds to the cooking demonstration and recipes in the participant handbook.The curriculum will include evidence based information on managing chronic diseases with nutrition and will be culturally tailored to include foods, music, and/or same race/ethnicity role models.
Active Comparator: Community Group; Participants are recruited from the community and Winston-Salem State University and enrolled in the intervention	Behavioral: Nutrition Matters; The intervention will consist of two components: educational sessions and a structured PA component. The primary purpose of the educational sessions is to increase experimental group participants' scientific knowledge and skills in healthy cooking and eating. NUTRITION-MATTERS includes weekly 1.5-hour education sessions for a total of 12 weeks. The sessions will be sequenced carefully to blend brief lectures by experts, experience sharing by participants, and an interactive cooking demonstration. All participants will be provided with $20 of food that corresponds to the cooking demonstration and recipes in the participant handbook.The curriculum will include evidence based information on managing chronic diseases with nutrition and will be culturally tailored to include foods, music, and/or same race/ethnicity role models.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake	24-hour Dietary Recalls	From enrollment to 3 months following the 12 week intervention (24 weeks)
Hemoglobin a1c	Hemoglobin a1c	From enrollment to 3 months following the 12 week intervention (24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Behaviors	Three-Factor Eating Questionnaire-Revised 18-Item Version	From enrollment to 3 months following the 12 week intervention (24 weeks)
Body Weight	Body Weight in pounds	From enrollment to 3 months following the 12 week intervention (24 weeks)
Waist circumference	Waist circumference in inches	From enrollment to 3 months following the 12 week intervention (24 weeks)
Blood pressure	Blood pressure was measured via sphygmomanometer	From enrollment to 3 months following the 12 week intervention (24 weeks)
Lipid Profile	Levels of LDL, HDL, total cholesterol, and triglycerides were measured	From enrollment to 3 months following the 12 week intervention (24 weeks)
Qualitative Data	Focus groups will be conducted to collect qualitative data. Research questions that will guide the focus groups are 1) What are the perceived barriers to healthy eating and accessing nutritious foods? (2) What intervention and cultural factors impact nutritional and physical activity behavioral changes in AAs? (3) What types of support aided in program adherence and behavioral changes?	3 months following the 12 week intervention

Collaborators and Investigators

• Sponsor: Winston Salem State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Multiple Chronic Conditions; Disease; Heart Diseases; Chronic Disease
• Other Study ID Numbers: FY2024-73; U24DK132715 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No