Treating Binge Eating and Obesity Digitally in Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Binge-Eating Disorder; Binge Eating; Weight Gain Prevention
• Intervention / Treatment: Behavioral: Centering Appetite

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyisha Harper, MBA; Phone Number: 704-250-5085; Email: tyharper@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill
      • Contact: Rachel Goode, PhD,MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention: Percentage of Participants Retained in the Study	Percentage of eligible participants who were enrolled and retained in the study through the 6 months.	6 months
Attendance: Percentage of Intervention Sessions Attended	Percentage of intervention sessions attended for the duration of the study by each participant.	6 months
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.	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 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.	Baseline, 6 months
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.	Baseline, 4 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.	Baseline, 4 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Rachel Goode, PhD,MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Hyperphagia; Signs and Symptoms, Digestive; Overweight; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Bulimia; Obesity; Binge-Eating Disorder
• Other Study ID Numbers: 21-2718; 5K23DK129832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No