DiabetesNCT07560969
Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
A study testing Culturally-tailored, enhanced adaption of Diabetes Prevention Program in people with Diabetes and Physical Activity, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Physical Activity, Food Security
- What is being tested?
- Culturally-tailored, enhanced adaption of Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 28 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Members of a participating church or user of a participating church's outreach services
- Age 18 years or older
- Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or ([body mass index > 24 or history of gestational diabetes] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)
Who cannot join
- Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
- Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn
- Individuals who are not able to engage in low-impact physical activity
- Individuals who do not speak English
- Individuals who live in a household with a participant in this study at a different church
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Missouri-Kansas City
Kansas City, Missouri, 64108
Jenifer E Allsworth, PhD, 816-235-1781, allsworthj@umkc.edu
About this study
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.
The main questions it aims to answer are:
Read more
- Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
- How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?
Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.
Participants will
- Attend DPP sessions delivered in community settings (e.g., churches)
- Receive lifestyle education focused on diet, physical activity, and weight loss
- Engage in physical activity (including in-class exercise sessions [E-DPP only] and community-based options)
- Receive support for healthy eating, including food deliveries ([E-DPP only]), food selection guidance, and referrals to food assistance programs
- Receive information and support for accessing community resources for food and physical activity
Read the detailed description
This study is a cluster-randomized clinical trial designed to evaluate the effectiveness of an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) compared to a standard culturally tailored DPP (S-DPP) among African American adults with prediabetes residing in low-income, socially vulnerable communities. The trial will enroll approximately 408 participants across 12 community-based sites (churches), which will be randomized to deliver either S-DPP or E-DPP to minimize contamination across intervention conditions.
Both intervention arms are grounded in the evidence-based DPP lifestyle intervention and incorporate cultural tailoring strategies to improve relevance and acceptability in African American communities. The enhanced intervention builds upon this foundation by explicitly addressing multilevel social determinants that influence engagement in healthy eating and physical activity. Specifically, E-DPP integrates structural supports to improve access to healthy foods and safe, low-cost physical activity opportunities, alongside strategies to address social stigma related to obesity, poverty, and food insecurity.
The E-DPP includes additional components delivered during and between sessions. These include provision of fruits and vegetables during sessions, experiential activities focused on healthy food selection and budgeting, and facilitated linkage to community food resources such as food pantries and assistance programs. Physical activity support includes structured in-session exercise and guidance on accessing community-based physical activity programs. Participants in the E-DPP arm will also receive tailored text messaging designed to reinforce behavior change, promote utilization of community resources, and reduce stigma-related barriers to engagement.
The intervention is delivered over a 12-month period, with assessments conducted at baseline, 6 months, and 12 months. A community-engaged approach informs intervention design and implementation, ensuring alignment with local context and resources. The study is guided by theoretical frameworks that emphasize the role of social and structural determinants in shaping health behaviors and outcomes.
In addition to evaluating intervention effects, the study will examine potential mediators and moderators of weight loss, including social determinant-related stressors, access to resources, and psychosocial factors. A concurrent process evaluation will assess intervention fidelity, dose, participant engagement, acceptability, and feasibility, as well as cost-related considerations. These data will inform identification of key intervention components and support future scalability and dissemination of the enhanced program in underserved communities.
- Conditions
- Diabetes, Physical Activity, Food Security, Nutrition Security
- Being tested
- Culturally-tailored, enhanced adaption of Diabetes Prevention Program
- Keywords
- diabetes, obesity, community-based participatory research, Weight loss, Cluster randomized trial, lifestyle change program, faith-based organizations, African American
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-tailored, enhanced adaption of Diabetes Prevention ProgramBehavioural
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance). Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery. Participants use Wi-Fi scales and fitness trackers to support behavior change. The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.
| Study group | Role | What they receive |
|---|---|---|
| Standard Diabetes Prevention Program (S-DPP) | Active comparator | Standard DPP (S-DPP) is a 12-month, in-person lifestyle intervention based on the CDC PreventT2 curriculum, delivered by community peer coaches across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Each session includes weigh-ins with REDCap capture, review of self-monitoring logs for diet, activity, and goals, and guided delivery of the curriculum. Participants receive Wi-Fi scales and fitness trackers to support weight loss and physical activity tracking. Certain sessions provide information on local, low- or no-cost food and physical activity resources to support and maintain behavior change. Receives: Behavioral: Culturally-tailored, enhanced adaption of Diabetes Prevention Program |
| Enhanced Diabetes Prevention Program (E-DPP) | Experimental | Enhanced DPP (E-DPP) is a 12-month intervention based on the CDC PreventT2 curriculum that integrates digital tools, community resources, and culturally tailored supports across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Sessions include weigh-ins with REDCap capture, review of self-monitoring logs, and guided curriculum delivery. Participants receive Wi-Fi scales and fitness trackers and access tailored text messages with DPP content and resource links. Coaches provide additional messaging support. The model also includes in-class healthy food distribution and culturally tailored physical activity sessions, as well as information on local low- or no-cost resources to support sustained behavior change. Receives: Behavioral: Culturally-tailored, enhanced adaption of Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
Measured: Baseline, 6 months, 12 months
Secondary outcomes (10)
Nutrition security
Self-reported nutrition security
Measured: Baseline, 6 months, 12 months
Dietary intake
Self-reported dietary quality that assesses alignment with US dietary guidelines
Measured: Baseline, 6 months, 12 months
DPP Attendance
Number of DPP sessions attended
Measured: 6 months
Physical activity (subjective)
Self-reported physical activity
Measured: Baseline, 6 months, 12 months
Physical activity (objective)
Physical activity measured by accelerometer
Measured: Baseline, 6 months
Use of community resources for food access
Self-reported use of food access community resources
Measured: Baseline, 6 months, 12 months
Use of community resources for physical activity
Self-reported use of physical activity community resources
Measured: Baseline, 6 months, 12 months
Blood pressure
Measured systolic and diastolic blood pressure
Measured: Baseline, 6 months, 12 months
Glycosylated hemoglobin
Measured A1c categorized via American Diabetes Association guidelines
Measured: Baseline, 6 months, 12 months
Food security
Self-reported measure of household food security
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start4 Jan 2027 (estimated)
- Primary completion28 Feb 2031 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This intervention adapts the CDC PreventT2 Diabetes Prevention Program (DPP) into two delivery models over 12 months, led by community peer coaches with student support and structured around 22 sessions (16 core, 6 maintenance). Both models emphasize engagement, self-monitoring, and culturally tailored support, with data captured via REDCap. Standard DPP (S-DPP) delivers in-person sessions following the PreventT2 curriculum. Coaches conduct outreach, lead a pre-session on disparities, goal setting, and barriers, and facilitate sessions with weigh-ins, tracking review, and curriculum delivery. Participants receive Wi-Fi scales and Fitbits. Enhanced DPP (E-DPP) integrates digital tools, resource navigation, and partnerships. Participants receive tailored text messages, track behaviors, and access resources. Coaches provide messaging support. The model includes food distributions and tailored physical activity sessions to address barriers and support behavior change.
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City, University of Massachusetts, Amherst, San Diego State University, University of Kansas
- Responsible party
- Principal investigator, Jenifer Allsworth, University of Missouri, Kansas City
- Investigators
- Jenifer E Jenifer, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560969
- Sponsor's protocol ID
- 2130354
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data for participants will be shared in an NIH-approved repository or made available by request from the PIs.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
- ClinicalTrials.gov ID
- NCT07560969
- Acronym / sponsor ID
- 2130354
- Conditions
- Diabetes, Physical Activity, Food Security, Nutrition Security
- Keywords
- diabetes, obesity, community-based participatory research, Weight loss, Cluster randomized trial, lifestyle change program, faith-based organizations, African American
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City, University of Massachusetts, Amherst, San Diego State University, University of Kansas
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 1 May 2026 (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.
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.
The main questions it aims to answer are:
- Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
- How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?
Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.
Participants will
- Attend DPP sessions delivered in community settings (e.g., churches)
- Receive lifestyle education focused on diet, physical activity, and weight loss
- Engage in physical activity (including in-class exercise sessions [E-DPP only] and community-based options)
- Receive support for healthy eating, including food deliveries ([E-DPP only]), food selection guidance, and referrals to food assistance programs
- Receive information and support for accessing community resources for food and physical activity
Detailed description
This study is a cluster-randomized clinical trial designed to evaluate the effectiveness of an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) compared to a standard culturally tailored DPP (S-DPP) among African American adults with prediabetes residing in low-income, socially vulnerable communities. The trial will enroll approximately 408 participants across 12 community-based sites (churches), which will be randomized to deliver either S-DPP or E-DPP to minimize contamination across intervention conditions.
Both intervention arms are grounded in the evidence-based DPP lifestyle intervention and incorporate cultural tailoring strategies to improve relevance and acceptability in African American communities. The enhanced intervention builds upon this foundation by explicitly addressing multilevel social determinants that influence engagement in healthy eating and physical activity. Specifically, E-DPP integrates structural supports to improve access to healthy foods and safe, low-cost physical activity opportunities, alongside strategies to address social stigma related to obesity, poverty, and food insecurity.
The E-DPP includes additional components delivered during and between sessions. These include provision of fruits and vegetables during sessions, experiential activities focused on healthy food selection and budgeting, and facilitated linkage to community food resources such as food pantries and assistance programs. Physical activity support includes structured in-session exercise and guidance on accessing community-based physical activity programs. Participants in the E-DPP arm will also receive tailored text messaging designed to reinforce behavior change, promote utilization of community resources, and reduce stigma-related barriers to engagement.
The intervention is delivered over a 12-month period, with assessments conducted at baseline, 6 months, and 12 months. A community-engaged approach informs intervention design and implementation, ensuring alignment with local context and resources. The study is guided by theoretical frameworks that emphasize the role of social and structural determinants in shaping health behaviors and outcomes.
In addition to evaluating intervention effects, the study will examine potential mediators and moderators of weight loss, including social determinant-related stressors, access to resources, and psychosocial factors. A concurrent process evaluation will assess intervention fidelity, dose, participant engagement, acceptability, and feasibility, as well as cost-related considerations. These data will inform identification of key intervention components and support future scalability and dissemination of the enhanced program in underserved communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This intervention adapts the CDC PreventT2 Diabetes Prevention Program (DPP) into two delivery models over 12 months, led by community peer coaches with student support and structured around 22 sessions (16 core, 6 maintenance). Both models emphasize engagement, self-monitoring, and culturally tailored support, with data captured via REDCap. Standard DPP (S-DPP) delivers in-person sessions following the PreventT2 curriculum. Coaches conduct outreach, lead a pre-session on disparities, goal setting, and barriers, and facilitate sessions with weigh-ins, tracking review, and curriculum delivery. Participants receive Wi-Fi scales and Fitbits. Enhanced DPP (E-DPP) integrates digital tools, resource navigation, and partnerships. Participants receive tailored text messages, track behaviors, and access resources. Coaches provide messaging support. The model includes food distributions and tailored physical activity sessions to address barriers and support behavior change.
| Arm | Type | Receives |
|---|---|---|
| Standard Diabetes Prevention Program (S-DPP) | Active comparator | Behavioral: Culturally-tailored, enhanced adaption of Diabetes Prevention ProgramStandard DPP (S-DPP) is a 12-month, in-person lifestyle intervention based on the CDC PreventT2 curriculum, delivered by community peer coaches across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Each session includes weigh-ins with REDCap capture, review of self-monitoring logs for diet, activity, and goals, and guided delivery of the curriculum. Participants receive Wi-Fi scales and fitness trackers to support weight loss and physical activity tracking. Certain sessions provide information on local, low- or no-cost food and physical activity resources to support and maintain behavior change. |
| Enhanced Diabetes Prevention Program (E-DPP) | Experimental | Behavioral: Culturally-tailored, enhanced adaption of Diabetes Prevention ProgramEnhanced DPP (E-DPP) is a 12-month intervention based on the CDC PreventT2 curriculum that integrates digital tools, community resources, and culturally tailored supports across 22 sessions (16 core, 6 maintenance). Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers. Sessions include weigh-ins with REDCap capture, review of self-monitoring logs, and guided curriculum delivery. Participants receive Wi-Fi scales and fitness trackers and access tailored text messages with DPP content and resource links. Coaches provide additional messaging support. The model also includes in-class healthy food distribution and culturally tailored physical activity sessions, as well as information on local low- or no-cost resources to support sustained behavior change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Members of a participating church or user of a participating church's outreach services
- Age 18 years or older
- Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or ([body mass index > 24 or history of gestational diabetes] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)
Key exclusion criteria (5 listed)
- Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
- Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn
- Individuals who are not able to engage in low-impact physical activity
- Individuals who do not speak English
- Individuals who live in a household with a participant in this study at a different church
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 |
|---|---|---|
| Culturally-tailored, enhanced adaption of Diabetes Prevention ProgramThis intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance). Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery. Participants use Wi-Fi scales and fitness trackers to support behavior change. The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability. | Behavioural | Enhanced Diabetes Prevention Program (E-DPP), Standard Diabetes Prevention Program (S-DPP) |
Primary outcome
Weight loss
Time frame: Baseline, 6 months, 12 months
Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
10 secondary outcomes
Nutrition security
Time frame: Baseline, 6 months, 12 months
Dietary intake
Time frame: Baseline, 6 months, 12 months
DPP Attendance
Time frame: 6 months
Physical activity (subjective)
Time frame: Baseline, 6 months, 12 months
Physical activity (objective)
Time frame: Baseline, 6 months
Use of community resources for food access
Time frame: Baseline, 6 months, 12 months
Use of community resources for physical activity
Time frame: Baseline, 6 months, 12 months
Blood pressure
Time frame: Baseline, 6 months, 12 months
Glycosylated hemoglobin
Time frame: Baseline, 6 months, 12 months
Food security
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified study data for participants will be shared in an NIH-approved repository or made available by request from the PIs.
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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.
Jenifer E Jenifer, PhD principal investigator
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-tailored, enhanced adaption of Diabetes Prevention Program in people with Diabetes and Physical Activity, run by University of Missouri, Kansas City 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 5 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: opening soon, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenifer E Allsworth, PhD (816-235-1781, allsworthj@umkc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Baseline, 6 months, 12 months). 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 9 Jun 2026.