ClinicalTrials.gg
Not yet recruitingNCT05693896Updated Aug 10, 2026

Treating Binge Eating and Obesity Digitally in Women

An interventional study of Centering Appetite in Binge Eating, Binge-Eating Disorder and Weight Gain Prevention, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Binge Eating
  • Binge-Eating Disorder
  • Weight Gain Prevention
  • Obesity
03

In context

Bulimia

173 studies on the registry are indexed under Bulimia; 33 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 143 interventional studies indexed under Bulimia.

Browse Bulimia studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.

Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age with pre-diabetes,
  • Have an (A1c between 5.7%-6.4%),
  • ≥ 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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • currently in treatment for eating difficulties,
  • are concurrent intravenous drug users
  • consume >4 alcoholic beverages/day
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Centering Appetite Intervention, Then Attention- Control Group

    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.

    Behavioral: Centering Appetite

  • No intervention
    Attention- Control Group, Then Centering Appetite 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.

Interventions

  • BehavioralCentering Appetite

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 month

  2. Retention: Percentage of Participants Retained in the Study

    Percentage of eligible participants who were enrolled and retained in the study through the 6 months.

    Time frame: 6 months

  3. Attendance: Percentage of Intervention Sessions Attended

    Percentage of intervention sessions attended for the duration of the study by each participant.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 4 months

  2. 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.

    Time frame: Baseline, 6 months

  3. 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.

    Time frame: Baseline, 4 months

  4. 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.

    Time frame: Baseline, 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 68 non-industry interventional studies with no phase under Bulimia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 12 months is below that.

Counting every sponsor, half of 70 studies reached it within 26 months; a quarter within 10 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2023
First posted
Jan 23, 2023
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05693896
Responsible party
Sponsor
First posted
Jan 23, 2023
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Tyisha Harper, MBA
Contact
tyharper@unc.edu
704-250-5085
Rachel Goode, PhD,MPH
principal investigator · University of North Carolina, Chapel Hill

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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