Clinical trial NCT06933940: NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions
Official title: NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Obesity and Obesity-related Medical Conditions
Heart Disease
Lead sponsor: Winston Salem State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of North Carolina, Chapel Hill
First posted: 2025-04-18
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Dietary Intake
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Hemoglobin a1c
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Secondary outcomes:
measure: Eating Behaviors
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Body Weight
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Waist circumference
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Blood pressure
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Lipid Profile
timeFrame: From enrollment to 3 months following the 12 week intervention (24 weeks)
measure: Qualitative Data
timeFrame: 3 months following the 12 week intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Winston-Salem State University
state: North Carolina
Study officials:
References: