Treating Binge Eating and Obesity Digitally in Black Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693896
• Other study ID #: 21-2718
• Secondary ID: 5K23DK129832-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Tyisha Harper, MBA
• Phone: 704-250-5085
• Email: tyharper[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity
• Weight Gain
• Weight Gain Prevention

Intervention

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.

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Attendance: Percentage of Intervention Sessions Attended	Percentage of intervention sessions attended for the duration of the study by each participant.	6 months
Secondary	Change from Baseline to Month 3 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, 3 months
Secondary	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
Secondary	Change in number of Binge Eating Episodes from Baseline to Month 3	Participant binge eating episodes will be self-monitored via the digital health tool.	Baseline, 3 months
Secondary	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