MedPath

Treating Binge Eating and Obesity Digitally in Black Women

Not Applicable
Not yet recruiting
Conditions
Binge-Eating Disorder
Obesity
Binge Eating
Weight Gain Prevention
Interventions
Behavioral: Centering Appetite
Registration Number
NCT05693896
Lead Sponsor
University of North Carolina, Chapel Hill
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
60
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Centering Appetite Intervention, Then Attention- Control GroupCentering AppetiteParticipants 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.
Primary Outcome Measures
NameTimeMethod
Attendance: Percentage of Intervention Sessions Attended6 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 Study3 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 Study6 months

Percentage of eligible participants who were enrolled and retained in the study through the 6 months.

Secondary Outcome Measures
NameTimeMethod
Change from Baseline to Month 6 in weight regainBaseline, 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.

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

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

Change from Baseline to Month 3 in weight regainBaseline, 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.

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

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

Trial Locations

Locations (1)

UNC-Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

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