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Treating Binge Eating and Obesity Digitally in Black Women

Primary Purpose

Binge Eating, Binge-Eating Disorder, Weight Gain Prevention

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Centering Appetite
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Binge Eating

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UNC-Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Centering Appetite Intervention, Then Attention- Control Group

Attention- Control Group, Then Centering Appetite Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
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
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Attendance: Percentage of Intervention Sessions Attended
Percentage of intervention sessions attended for the duration of the study by each participant.

Secondary Outcome Measures

Change from Baseline to Month 3 in weight regain
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
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 3
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
Participant binge eating episodes will be self-monitored via the digital health tool.

Full Information

First Posted
January 11, 2023
Last Updated
January 11, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05693896
Brief Title
Treating Binge Eating and Obesity Digitally in Black Women
Official Title
Treating Binge Eating and Obesity Digitally in Black Women: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating, Binge-Eating Disorder, Weight Gain Prevention, Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Centering Appetite Intervention, Then Attention- Control Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention- Control Group, Then Centering Appetite Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Centering Appetite
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study
Description
Recruitment is defined as the number of potential eligible adults screened for the study versus the number of persons who enrolled in the study.
Time Frame
3 month
Title
Retention: Percentage of Participants Retained in the Study
Description
Percentage of eligible participants who were enrolled and retained in the study through the 6 months.
Time Frame
6 months
Title
Attendance: Percentage of Intervention Sessions Attended
Description
Percentage of intervention sessions attended for the duration of the study by each participant.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline to Month 3 in weight regain
Description
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.
Time Frame
Baseline, 3 months
Title
Change from Baseline to Month 6 in weight regain
Description
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.
Time Frame
Baseline, 6 months
Title
Change in number of Binge Eating Episodes from Baseline to Month 3
Description
Participant binge eating episodes will be self-monitored via the digital health tool.
Time Frame
Baseline, 3 months
Title
Change in number of Binge Eating Episodes from Baseline to Month 6
Description
Participant binge eating episodes will be self-monitored via the digital health tool.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyisha Harper, MBA
Phone
704-250-5085
Email
tyharper@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Goode, PhD,MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Goode, PhD,MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Binge Eating and Obesity Digitally in Black Women

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