Type 2 DiabetesNCT06933940
NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions
A study testing Nutrition Matters in people with Type 2 Diabetes and Hypertension, run by Winston Salem State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Nutrition Matters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Winston-Salem State University
Winston-Salem, North Carolina, 27110
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Hypertension, Obesity and Obesity-related Medical Conditions, Heart Disease
- Being tested
- Nutrition Matters
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Obesity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition MattersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Church Group | Experimental | Participants recruited from a church congregation were enrolled in this group. Receives: Behavioral: Nutrition Matters |
| Community Group | Active comparator | Participants are recruited from the community and Winston-Salem State University and enrolled in the intervention Receives: Behavioral: Nutrition Matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake
24-hour Dietary Recalls
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Hemoglobin a1c
Hemoglobin a1c
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Secondary outcomes (6)
Eating Behaviors
Three-Factor Eating Questionnaire-Revised 18-Item Version
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Body Weight
Body Weight in pounds
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Waist circumference
Waist circumference in inches
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Blood pressure
Blood pressure was measured via sphygmomanometer
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Lipid Profile
Levels of LDL, HDL, total cholesterol, and triglycerides were measured
Measured: From enrollment to 3 months following the 12 week intervention (24 weeks)
Qualitative Data
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?
Measured: 3 months following the 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Sep 2024
- Primary completion1 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Salem State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Krista D. Sowell, PhD, Winston Salem State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933940
- Sponsor's protocol ID
- FY2024-73
- Other IDs
- U24DK132715
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT06933940
- Acronym / sponsor ID
- FY2024-73
- Conditions
- Type 2 Diabetes, Hypertension, Obesity and Obesity-related Medical Conditions, Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Winston Salem State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Church Group | Experimental | Behavioral: Nutrition MattersParticipants recruited from a church congregation were enrolled in this group. |
| Community Group | Active comparator | Behavioral: Nutrition MattersParticipants are recruited from the community and Winston-Salem State University and enrolled in the intervention |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition MattersThe 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. | Behavioural | Church Group, Community Group |
Primary outcome
Dietary Intake
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
24-hour Dietary Recalls
Hemoglobin a1c
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Hemoglobin a1c
6 secondary outcomes
Eating Behaviors
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Body Weight
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Waist circumference
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Blood pressure
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Lipid Profile
Time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)
Qualitative Data
Time frame: 3 months following the 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Matters in people with Type 2 Diabetes and Hypertension, run by Winston Salem State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Intake (time frame: From enrollment to 3 months following the 12 week intervention (24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.