Binge Eating, Binge-Eating Disorder, Obesity, Weight Gain Prevention
Conditions
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.
Interventions
BEHAVIORALCentering 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.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years of age with pre-diabetes, * Have an (A1c between 5.7%-6.4%), * 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, * Have not used prescription weight loss medications (like Wegovy, Zepbound, or Ozempic) in the past 3 months
Exclusion criteria
* currently pregnant, * Are currently taking or have taken within the prior 3 months (12 weeks) a GLP-1, * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study | 4 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 | 6 months | Percentage of eligible participants who were enrolled and retained in the study through the 6 months. |
| Attendance: Percentage of Intervention Sessions Attended | 6 months | Percentage of intervention sessions attended for the duration of the study by each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Month 4 in weight regain | Baseline, 4 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 from Baseline to Month 6 in weight regain | 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. |
| Change in number of Binge Eating Episodes from Baseline to Month 4 | Baseline, 4 months | Participant binge eating episodes will be self-monitored via the digital health tool. |
| Change in number of Binge Eating Episodes from Baseline to Month 6 | Baseline, 6 months | Participant binge eating episodes will be self-monitored via the digital health tool. |
Countries
United States
Contacts
CONTACTTyisha Harper, MBA
PRINCIPAL_INVESTIGATORRachel Goode, PhD,MPH
University of North Carolina, Chapel Hill
Outcome results
None listed