Type 2 Diabetes MellitusNCT06848244
Preventing Type 2 Diabetes in Black Emergent Adult
A study testing Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) in people with Type 2 Diabetes Mellitus and Binge-Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Binge-Eating Disorder, Binge Eating
- What is being tested?
- Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to Dec 2030
- 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 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Black women
- between 18-25 years of age
- BMI ≥ 25 kg/m^2
- At least one binge eating episode weekly
- Prediabetic
- Have access to a smartphone
Who cannot join
- Have no internet access
- Currently type 2 diabetic
- Currently pregnant
- Are in substance use treatment
- Have received prior or planned bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Type 2 Diabetes in Black Emergent Adult Women At-Risk for Binge-Eating Disorder
Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).
Read the detailed description
Aim 1. Use formative research to gather recommendations to Tailor AAT+DPP to Black Emergent Adult (EA) Women (Year 1).
Aim 2. Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED (Year 2).
Aim 3. Conduct a pilot randomized trial to examine the feasibility and acceptability, and preliminary efficacy of the adapted AAT+ DPP intervention (Years 3-4; Analysis Year 5).
- Conditions
- Type 2 Diabetes Mellitus, Binge-Eating Disorder, Binge Eating, Obesity
- Being tested
- Appetite Awareness Training (AAT), Diabetes Prevention Program (DPP)
- Medical subject headings
- Diabetes Mellitus, Type 2, Binge-Eating Disorder, Bulimia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appetite Awareness Training (AAT)Behavioural
Participants will receive the AAT delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.
Diabetes Prevention Program (DPP)Behavioural
Participants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) | Experimental | Participants are randomized into the AAT and DPP groups and receive content from both programs for 12 months. Receives: Behavioral: Appetite Awareness Training (AAT); Behavioral: Diabetes Prevention Program (DPP) |
| Diabetes Prevention Program (DPP) only | Experimental | Participants are randomized into the DPP group and will be able to access the program's content. Receives: Behavioral: Diabetes Prevention Program (DPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Binge Eating Episodes from Baseline to Month 6
Participants will self-monitor and complete surveys on binge eating episodes.
Measured: Baseline, 6 months
Change from Baseline to Month 6 in weight regain
Participant body weight will be measured by trained research staff using calibrated digital scales. Participants will be in light indoor clothing, with pockets emptied, and belts and shoes removed.
Measured: Baseline, 6 months
Secondary outcomes (1)
Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6
Participants will provide plasma samples to examine the risk for type 2 diabetes mellitus.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start30 Jun 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Rachel Goode, PhD,MPH,LCSW, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848244
- Sponsor's protocol ID
- 25-0125
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2025
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Type 2 Diabetes in Black Emergent Adult Women At-Risk for Binge-Eating Disorder
- ClinicalTrials.gov ID
- NCT06848244
- Acronym / sponsor ID
- 25-0125
- Conditions
- Type 2 Diabetes Mellitus, Binge-Eating Disorder, Binge Eating, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Feb 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.
Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).
Detailed description
Aim 1. Use formative research to gather recommendations to Tailor AAT+DPP to Black Emergent Adult (EA) Women (Year 1).
Aim 2. Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED (Year 2).
Aim 3. Conduct a pilot randomized trial to examine the feasibility and acceptability, and preliminary efficacy of the adapted AAT+ DPP intervention (Years 3-4; Analysis Year 5).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) | Experimental | Behavioral: Appetite Awareness Training (AAT), Behavioral: Diabetes Prevention Program (DPP)Participants are randomized into the AAT and DPP groups and receive content from both programs for 12 months. |
| Diabetes Prevention Program (DPP) only | Experimental | Behavioral: Diabetes Prevention Program (DPP)Participants are randomized into the DPP group and will be able to access the program's content. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Black women
- between 18-25 years of age
- BMI ≥ 25 kg/m^2
- At least one binge eating episode weekly
- Prediabetic
Key exclusion criteria (5 listed)
- Have no internet access
- Currently type 2 diabetic
- Currently pregnant
- Are in substance use treatment
- Have received prior or planned bariatric surgery
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 |
|---|---|---|
| Appetite Awareness Training (AAT)Participants will receive the AAT delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months. | Behavioural | Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) |
| Diabetes Prevention Program (DPP)Participants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months. | Behavioural | Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP), Diabetes Prevention Program (DPP) only |
Primary outcome
Change in number of Binge Eating Episodes from Baseline to Month 6
Time frame: Baseline, 6 months
Participants will self-monitor and complete surveys on binge eating episodes.
Change from Baseline to Month 6 in weight regain
Time frame: Baseline, 6 months
Participant body weight will be measured by trained research staff using calibrated digital scales. Participants will be in light indoor clothing, with pockets emptied, and belts and shoes removed.
1 secondary outcome
Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6
Time frame: Baseline, 6 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 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Rachel Goode, PhD,MPH,LCSW principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) in people with Type 2 Diabetes Mellitus and Binge-Eating Disorder, run by University of North Carolina, Chapel Hill 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 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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?
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?
Change in number of Binge Eating Episodes from Baseline to Month 6 (time frame: Baseline, 6 months). 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 25 Aug 2026.