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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06933940
• Lead Sponsor: Winston Salem State University

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.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-01
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study Completion: 2025-04-15
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dietary Intake	From enrollment to 3 months following the 12 week intervention (24 weeks)	24-hour Dietary Recalls
Hemoglobin a1c	From enrollment to 3 months following the 12 week intervention (24 weeks)	Hemoglobin a1c

Secondary Outcome Measures

Name	Time	Method
Eating Behaviors	From enrollment to 3 months following the 12 week intervention (24 weeks)	Three-Factor Eating Questionnaire-Revised 18-Item Version
Body Weight	From enrollment to 3 months following the 12 week intervention (24 weeks)	Body Weight in pounds
Waist circumference	From enrollment to 3 months following the 12 week intervention (24 weeks)	Waist circumference in inches
Blood pressure	From enrollment to 3 months following the 12 week intervention (24 weeks)	Blood pressure was measured via sphygmomanometer
Lipid Profile	From enrollment to 3 months following the 12 week intervention (24 weeks)	Levels of LDL, HDL, total cholesterol, and triglycerides were measured
Qualitative Data	3 months following the 12 week intervention	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?

Trial Locations

Locations (1)

Winston-Salem State University; 🇺🇸 Winston-Salem, North Carolina, United States