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Clinical Trials/NCT05693896
NCT05693896
Recruiting
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country60 target enrollmentJanuary 15, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Binge Eating
Sponsor
University of North Carolina, Chapel Hill
Enrollment
60
Locations
1
Primary Endpoint
Attendance: Percentage of Intervention Sessions Attended
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2025
End Date
December 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Attendance: Percentage of Intervention Sessions Attended

Time Frame: 6 months

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

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.

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.

Secondary Outcomes

  • 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 from Baseline to Month 3 in weight regain(Baseline, 3 months)
  • Change in number of Binge Eating Episodes from Baseline to Month 6(Baseline, 6 months)

Study Sites (1)

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