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

NCT06933940 | Completed

• 2 other identifiers: FY2024-73U24DK132715
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Dietary Intake

  24-hour Dietary Recalls

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

• Hemoglobin a1c

  Hemoglobin a1c

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

Secondary Outcomes (6)

• Eating Behaviors

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

• Body Weight

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

• Waist circumference

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

• Blood pressure

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

• Lipid Profile

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

Study Arms (2)

Church Group

EXPERIMENTAL

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

Behavioral: Nutrition Matters

Community Group

ACTIVE COMPARATOR

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

Behavioral: Nutrition Matters

Interventions

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.

Church Group; Community Group

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity

Sponsors & Collaborators

• Winston Salem State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Winston-Salem State University

Winston-Salem, North Carolina, 27110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Obesity; Heart Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)