Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06933940
Enrollment
26
Registered
2025-04-18
Start date
2024-09-01
Completion date
2025-04-15
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALNutrition 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of North Carolina, Chapel Hill
CollaboratorOTHER
Winston Salem State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dietary IntakeFrom enrollment to 3 months following the 12 week intervention (24 weeks)24-hour Dietary Recalls
Hemoglobin a1cFrom enrollment to 3 months following the 12 week intervention (24 weeks)Hemoglobin a1c

Secondary

MeasureTime frameDescription
Waist circumferenceFrom enrollment to 3 months following the 12 week intervention (24 weeks)Waist circumference in inches
Blood pressureFrom enrollment to 3 months following the 12 week intervention (24 weeks)Blood pressure was measured via sphygmomanometer
Eating BehaviorsFrom enrollment to 3 months following the 12 week intervention (24 weeks)Three-Factor Eating Questionnaire-Revised 18-Item Version
Qualitative Data3 months following the 12 week interventionFocus 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?
Lipid ProfileFrom enrollment to 3 months following the 12 week intervention (24 weeks)Levels of LDL, HDL, total cholesterol, and triglycerides were measured
Body WeightFrom enrollment to 3 months following the 12 week intervention (24 weeks)Body Weight in pounds

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026