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NCT Number: NCT05693896

Treating Binge Eating and Obesity Digitally in Black Women

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.

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Key information

Conditions

Binge Eating Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Weight Gain Prevention

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Rachel Goode, PhD,MPH

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study

    Time frame: 3 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.

  2. 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.

  3. Attendance: Percentage of Intervention Sessions Attended

    Time frame: 6 months

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

Secondary outcomes

  1. Change from Baseline to Month 3 in weight regain

    Time frame: Baseline, 3 months

    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.

  2. Change from Baseline to Month 6 in weight regain

    Time frame: Baseline, 6 months

    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.

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

    Time frame: Baseline, 3 months

    Participant binge eating episodes will be self-monitored via the digital health tool.

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

    Time frame: Baseline, 6 months

    Participant binge eating episodes will be self-monitored via the digital health tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Tyisha Harper, MBA

CONTACT

[email protected]

704-250-5085

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

Treating Binge Eating and Obesity Digitally in Black Women: A Feasibility Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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