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

NCT ID: NCT06933940

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-04-15

Brief Summary

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.

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.

Conditions

Type 2 Diabetes; Hypertension; Obesity and Obesity-related Medical Conditions; Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Church Group

Participants recruited from a church congregation were enrolled in this group.

Group Type: EXPERIMENTAL

Nutrition Matters

Intervention Type: BEHAVIORAL

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.

Community Group

Participants are recruited from the community and Winston-Salem State University and enrolled in the intervention

Group Type: ACTIVE_COMPARATOR

Nutrition Matters

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Winston Salem State University

OTHER

Sponsor Role: lead

Responsible Party

Krista D. Sowell, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Winston-Salem State University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

U24DK132715

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FY2024-73

Identifier Type: -

Identifier Source: org_study_id