Treating Binge Eating and Obesity Digitally in Black Women

NCT ID: NCT05693896

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Centering Appetite

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Over 18 years of age,
• 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,
• complete the screening questionnaire

Exclusion Criteria

• currently pregnant,
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Goode, PhD,MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tyisha Harper, MBA

Role: CONTACT

tyharper@unc.edu

704-250-5085

Facility Contacts

Rachel Goode, PhD,MPH

Role: primary

Other Identifiers

5K23DK129832

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-2718

Identifier Type: -

Identifier Source: org_study_id