Treating Binge Eating and Obesity Digitally in Black Women

NCT05693896 | Recruiting

• 2 other identifiers: 21-27185K23DK129832
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating; Binge-Eating Disorder; Weight Gain Prevention; Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  3 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.

  6 months

• Attendance: Percentage of Intervention Sessions Attended

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

  6 months

Secondary Outcomes (4)

• Change from Baseline to Month 3 in weight regain

  Baseline, 3 months

• Change from Baseline to Month 6 in weight regain

  Baseline, 6 months

• Change in number of Binge Eating Episodes from Baseline to Month 3

  Baseline, 3 months

• Change in number of Binge Eating Episodes from Baseline to Month 6

  Baseline, 6 months

Study Arms (2)

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.

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.

Interventions

Centering Appetite 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.

Centering Appetite Intervention, Then Attention- Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Bulimia; Binge-Eating Disorder; Obesity

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Rachel Goode, PhD,MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyisha Harper, MBA

CONTACT

704-250-5085; tyharper@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)