Treating Binge Eating and Obesity Digitally in Black Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Centering Appetite.
- Who it may be relevant to
- Registry conditions: Binge Eating, Binge-Eating Disorder, Weight Gain Prevention, Obesity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treating Binge Eating and Obesity Digitally in Black Women: A Feasibility Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study [Time frame: 3 month]
- Retention: Percentage of Participants Retained in the Study [Time frame: 6 months]
- Attendance: Percentage of Intervention Sessions Attended [Time frame: 6 months]
Secondary outcome measures (4)
- Change from Baseline to Month 3 in weight regain [Time frame: Baseline, 3 months]
- Change from Baseline to Month 6 in weight regain [Time frame: Baseline, 6 months]
- Change in number of Binge Eating Episodes from Baseline to Month 3 [Time frame: Baseline, 3 months]
- Change in number of Binge Eating Episodes from Baseline to Month 6 [Time frame: Baseline, 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UNC-Chapel Hill — Chapel Hill
Identifiers
NCT: NCT05693896 · 21-2718 · 5K23DK129832