Binge EatingNCT05693896
Treating Binge Eating and Obesity Digitally in Women
A study testing Centering Appetite in people with Binge Eating and Binge-Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating, Binge-Eating Disorder, Weight Gain Prevention
- What is being tested?
- 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
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age with pre-diabetes,
- Have an (A1c between 5.7%-6.4%),
- BMI ≥ 30 kg/m^2,
- have and regularly use a Bluetooth-enabled smartphone,
- report at least one binge eating episode weekly,
- work or live within 30 miles of Kannapolis, NC,
- Have not used prescription weight loss medications (like Wegovy, Zepbound, or Ozempic) in the past 3 months
Who cannot join
- currently pregnant,
- Are currently taking or have taken within the prior 3 months (12 weeks) a GLP-1,
- in substance abuse treatment,
- involved in another weight reduction program,
- have a history of anorexia,
- are purging,
Show all 9Show fewer
- currently in treatment for eating difficulties,
- are concurrent intravenous drug users
- consume >4 alcoholic beverages/day
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
UNC-Chapel Hill
Chapel Hill, North Carolina, 27599
Rachel Goode, PhD,MPH
About this study
Official title: Treating Binge Eating and Obesity Digitally in Women: A Feasibility Study (LISTEN Study)
More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.
Read the detailed description
Aim 1. Modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for Black women (BMI > 30 kg/m^2) who binge eat.
Aim 1a. Identify the barriers and facilitators to detecting and treating binge eating in Black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population.
Aim 1b. Conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool.
Aim 2. In a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.
- Conditions
- Binge Eating, Binge-Eating Disorder, Weight Gain Prevention, Obesity
- Being tested
- Centering Appetite
- Medical subject headings
- Bulimia, Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centering AppetiteBehavioural
A digital treatment of Appetite Awareness Treatment (AAT) and behavioral weight loss treatment (BWL) over 6 months, delivered remotely using Zoom. The goal of AAT is to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants diagnosed with Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in response to non-appetite stimuli, and prevent weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Centering Appetite Intervention, Then Attention- Control Group | Experimental | Participants randomized to the attention-control group will participate remotely via a smartphone app and online lessons. The intervention will build participants' self-efficacy to reduce binge eating and to assist them in preventing weight gain. Receives: Behavioral: Centering Appetite |
| Attention- Control Group, Then Centering Appetite Intervention | No intervention | Participants randomized to the centering appetite intervention group will receive weekly psychoeducation emails about general wellness topics, discussion of binge eating, diet, and physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
Measured: 4 month
Retention: Percentage of Participants Retained in the Study
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Measured: 6 months
Attendance: Percentage of Intervention Sessions Attended
Percentage of intervention sessions attended for the duration of the study by each participant.
Measured: 6 months
Secondary outcomes (4)
Change from Baseline to Month 4 in weight regain
Participant body weight will be measured by trained research staff using calibrated digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.
Measured: Baseline, 4 months
Change from Baseline to Month 6 in weight regain
Participant body weight will be measured by trained research staff using calibrated digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.
Measured: Baseline, 6 months
Change in number of Binge Eating Episodes from Baseline to Month 4
Participant binge eating episodes will be self-monitored via the digital health tool.
Measured: Baseline, 4 months
Change in number of Binge Eating Episodes from Baseline to Month 6
Participant binge eating episodes will be self-monitored via the digital health tool.
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 posted23 Jan 2023
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Goode, PhD,MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693896
- Sponsor's protocol ID
- 21-2718
- Other IDs
- 5K23DK129832
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2023
- Last updated
- 10 Aug 2026
- Results posted
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Binge Eating and Obesity Digitally in Women: A Feasibility Study (LISTEN Study)
- ClinicalTrials.gov ID
- NCT05693896
- Acronym / sponsor ID
- 21-2718
- Conditions
- Binge Eating, Binge-Eating Disorder, Weight Gain Prevention, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jan 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.
More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.
Detailed description
Aim 1. Modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for Black women (BMI > 30 kg/m^2) who binge eat.
Aim 1a. Identify the barriers and facilitators to detecting and treating binge eating in Black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population.
Aim 1b. Conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool.
Aim 2. In a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centering Appetite Intervention, Then Attention- Control Group | Experimental | Behavioral: Centering AppetiteParticipants randomized to the attention-control group will participate remotely via a smartphone app and online lessons. The intervention will build participants' self-efficacy to reduce binge eating and to assist them in preventing weight gain. |
| Attention- Control Group, Then Centering Appetite Intervention | No intervention | –Participants randomized to the centering appetite intervention group will receive weekly psychoeducation emails about general wellness topics, discussion of binge eating, diet, and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years of age with pre-diabetes,
- Have an (A1c between 5.7%-6.4%),
- BMI ≥ 30 kg/m^2,
- have and regularly use a Bluetooth-enabled smartphone,
- report at least one binge eating episode weekly,
Key exclusion criteria (9 listed)
- currently pregnant,
- Are currently taking or have taken within the prior 3 months (12 weeks) a GLP-1,
- in substance abuse treatment,
- involved in another weight reduction program,
- have a history of anorexia,
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 |
|---|---|---|
| Centering AppetiteA digital treatment of Appetite Awareness Treatment (AAT) and behavioral weight loss treatment (BWL) over 6 months, delivered remotely using Zoom. The goal of AAT is to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants diagnosed with Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in response to non-appetite stimuli, and prevent weight gain. | Behavioural | Centering Appetite Intervention, Then Attention- Control Group |
Primary outcome
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
Time frame: 4 month
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
Retention: Percentage of Participants Retained in the Study
Time frame: 6 months
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Attendance: Percentage of Intervention Sessions Attended
Time frame: 6 months
Percentage of intervention sessions attended for the duration of the study by each participant.
4 secondary outcomes
Change from Baseline to Month 4 in weight regain
Time frame: Baseline, 4 months
Change from Baseline to Month 6 in weight regain
Time frame: Baseline, 6 months
Change in number of Binge Eating Episodes from Baseline to Month 4
Time frame: Baseline, 4 months
Change in number of Binge Eating Episodes 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 10 Aug 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.
Rachel Goode, PhD,MPH 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 Centering Appetite in people with Binge Eating 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 7 inclusion and 9 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 10 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?
Contact Tyisha Harper, MBA (704-250-5085, tyharper@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study (time frame: 4 month). The study lists 3 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 10 Aug 2026.