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Completed

NCT Number: NCT06933940

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Matters

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.

Primary outcomes

  1. Dietary Intake

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    24-hour Dietary Recalls

  2. Hemoglobin a1c

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Hemoglobin a1c

Secondary outcomes

  1. Eating Behaviors

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Three-Factor Eating Questionnaire-Revised 18-Item Version

  2. Body Weight

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Body Weight in pounds

  3. Waist circumference

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Waist circumference in inches

  4. Blood pressure

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Blood pressure was measured via sphygmomanometer

  5. Lipid Profile

    Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)

    Levels of LDL, HDL, total cholesterol, and triglycerides were measured

  6. Qualitative Data

    Time frame: 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

    • 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?

Sponsors and collaborators

Lead sponsor

Winston Salem State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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