Treating Binge Eating and Obesity Digitally in Black Women

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05693896
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
60
1
2
11
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Centering Appetite
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Treating Binge Eating and Obesity Digitally in Black Women: A Feasibility Study
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Centering Appetite Intervention, Then Attention- Control Group

Participants 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.

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.

No Intervention: Attention- Control Group, Then Centering Appetite Intervention

Participants randomized to the centering appetite intervention group will receive weekly psychoeducation emails about general wellness topics, discussion of binge eating, diet, and physical activity.

Outcome Measures

Primary Outcome Measures

  1. Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study [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.

  2. 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.

  3. Attendance: Percentage of Intervention Sessions Attended [6 months]

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

Secondary Outcome Measures

  1. Change from Baseline to Month 3 in weight regain [Baseline, 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.

  2. 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.

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

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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UNC-Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Rachel Goode, PhD,MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT05693896
Other Study ID Numbers:
  • 21-2718
  • 5K23DK129832-02
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023