Type 2 DiabetesNCT05741125
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
A study testing DSME + ASE intervention (Centering Appetite) in people with Type 2 Diabetes and Binge Eating, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Binge Eating
- What is being tested?
- DSME + ASE intervention (Centering Appetite)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2025to 1 Mar 2027
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals are eligible if they
- identify as a Non-Hispanic, AA
- are over 18 years of age
- have an A1c value > 7.5
- have a working Smartphone
- complete binge eating screening
Who cannot join
- Individuals will be excluded if they:
- have major end-organ type 2 diabetes mellitus complications
- have a history of weight loss surgery
- are currently pregnant
- in substance use treatment or are involved in another weight reduction program.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rachel W. Goode
Kannapolis, North Carolina, 28081
UNC Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.
Read the detailed description
Using a randomized clinical trial design examine the feasibility and acceptability of a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention for (n=60) African Americans (AA) with type 2 diabetes who report uncontrolled eating in North Carolina. Sixty AAs will be randomized to the Centering Appetite intervention or the control group. Over the 6 months, Centering Appetite participants will have two intervention sessions supplemented by monthly booster sessions and weekly messages related to the program. The control group will also receive two intervention sessions and weekly nutrition tutorials. The study will examine the following: recruitment feasibility, attendance/retention, treatment adherence, intervention, HbA1c, and binge eating.
- Conditions
- Type 2 Diabetes, Binge Eating
- Being tested
- DSME + ASE intervention (Centering Appetite)
- Keywords
- Bing Eating, Type 2 Diabetes, African Americans, Digital
- Medical subject headings
- Diabetes Mellitus, Type 2, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSME + ASE intervention (Centering Appetite)Behavioural
Also called Improving Appetite Self-Regulation in African American Adults with Type 2 Diabetes
The intervention will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app.
| Study group | Role | What they receive |
|---|---|---|
| DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite) | Experimental | The Diabetes Self-Management Education and Support (DSMES) + Appetite Self-Regulation (ASE) intervention includes two, 45-60-minute group sessions delivered via telehealth. These sessions will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app. Receives: Behavioral: DSME + ASE intervention (Centering Appetite) |
| Control | No intervention | Control group participants will attend two remotely delivered DSMES sessions that will offer content commonly. They will also receive weekly emails providing content from the American Association of Diabetes Educators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Measured: Baseline
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Measured: Month 6
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
The number of potential participants who attended intervention sessions versus the number of persons who enrolled in the study and did not attend intervention sessions.
Measured: Month 6
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Percentage of participants retained in the study following enrollment.
Measured: Month 6
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Percentage of participants who adheres to study protocol.
Measured: Month 6
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
Participant satisfaction will be measured using a self-report scale at month 6. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). This is a 4-item scale with 1 being the lowest measure and 5 being the highest measure.
Measured: Month 6
Secondary outcomes (4)
Changes in HbA1C
Participant HbA1C will be measured using a glycohemoglobin analyzer.
Measured: Baseline, Month 6
Changes in Weight
Participant body weight will be measured by trained research staff using a calibrated digital scale.
Measured: Baseline, Month 6
Changes in Blood Pressures (Systolic and Diastolic pressure)
Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.
Measured: Baseline, Month 6
Changes in Binge Eating Episodes
Participant binge eating episodes will be measured using the Binge Eating Scale (BES). This is a 16-item psychological self-assessment tool used to assess the severity of binge eating behavior. Minimum values are: 0-17 which indicates non-binge eating, and the maximum values are anything greater than 27, which indicates severe binge eating.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start22 Jan 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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 at Chapel Hil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741125
- Sponsor's protocol ID
- 22-2237
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2023
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
- ClinicalTrials.gov ID
- NCT05741125
- Acronym / sponsor ID
- 22-2237
- Conditions
- Type 2 Diabetes, Binge Eating
- Keywords
- Bing Eating, Type 2 Diabetes, African Americans, Digital
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Feb 2023 (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 purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.
Detailed description
Using a randomized clinical trial design examine the feasibility and acceptability of a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention for (n=60) African Americans (AA) with type 2 diabetes who report uncontrolled eating in North Carolina. Sixty AAs will be randomized to the Centering Appetite intervention or the control group. Over the 6 months, Centering Appetite participants will have two intervention sessions supplemented by monthly booster sessions and weekly messages related to the program. The control group will also receive two intervention sessions and weekly nutrition tutorials. The study will examine the following: recruitment feasibility, attendance/retention, treatment adherence, intervention, HbA1c, and binge eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite) | Experimental | Behavioral: DSME + ASE intervention (Centering Appetite)The Diabetes Self-Management Education and Support (DSMES) + Appetite Self-Regulation (ASE) intervention includes two, 45-60-minute group sessions delivered via telehealth. These sessions will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app. |
| Control | No intervention | –Control group participants will attend two remotely delivered DSMES sessions that will offer content commonly. They will also receive weekly emails providing content from the American Association of Diabetes Educators. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals are eligible if they
- identify as a Non-Hispanic, AA
- are over 18 years of age
- have an A1c value > 7.5
- have a working Smartphone
Key exclusion criteria (5 listed)
- have major end-organ type 2 diabetes mellitus complications
- have a history of weight loss surgery
- are currently pregnant
- in substance use treatment or are involved in another weight reduction program.
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 |
|---|---|---|
| DSME + ASE intervention (Centering Appetite)Also: Improving Appetite Self-Regulation in African American Adults with Type 2 DiabetesThe intervention will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app. | Behavioural | DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite) |
Primary outcome
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
Time frame: Baseline
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
Time frame: Month 6
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
Time frame: Month 6
The number of potential participants who attended intervention sessions versus the number of persons who enrolled in the study and did not attend intervention sessions.
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Time frame: Month 6
Percentage of participants retained in the study following enrollment.
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Time frame: Month 6
Percentage of participants who adheres to study protocol.
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
Time frame: Month 6
Participant satisfaction will be measured using a self-report scale at month 6. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). This is a 4-item scale with 1 being the lowest measure and 5 being the highest measure.
4 secondary outcomes
Changes in HbA1C
Time frame: Baseline, Month 6
Changes in Weight
Time frame: Baseline, Month 6
Changes in Blood Pressures (Systolic and Diastolic pressure)
Time frame: Baseline, Month 6
Changes in Binge Eating Episodes
Time frame: Baseline, Month 6
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 4 Sep 2026.
- 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.
Rachel Goode, PhD, MPH, LCSW principal investigator
University of North Carolina at Chapel Hil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSME + ASE intervention (Centering Appetite) in people with Type 2 Diabetes and Binge Eating, run by University of North Carolina, Chapel Hill at 2 sites 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline (time frame: Baseline). The study lists 6 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 4 Sep 2026.