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Reducing Binge Eating to Prevent Weight Gain in Black Women

Primary Purpose

Binge Eating, Weight Loss, Weight Gain Prevention

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appetite Awareness Treatment + Lifestyle Modification
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Individuals are eligible if they are:

  • non-Latino Black women,
  • over 18 years of age,
  • have a BMI ≥ 25kg/m^2,
  • use a Bluetooth-enabled smartphone,
  • report at least one binge eating episode weekly, and
  • complete the screening.

Exclusion Criteria:

Individuals will be excluded if they:

  • are currently pregnant,
  • are in substance abuse treatment,
  • are involved in another weight reduction program,
  • have a history of anorexia,
  • are purging,
  • are currently in treatment for eating difficulties,
  • are concurrent intravenous drug users or consume >4 alcoholic beverages/day.

Sites / Locations

  • Nutrition Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)

Control

Arm Description

Participants will receive an 8-week Appetite Awareness Training (AAT) program using a group format, will be provided a smart scale (with bluetooth connection) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessment will be conducted at 0, 2, and 6 months.

Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.

Outcomes

Primary Outcome Measures

Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Feasibility (Retention): Percentage of Participants Retained in the Study
Percentage of participants retained in the study following enrollment through month 6
Feasibility (Attendance): Percentage of Sessions That Were Attended
Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100.

Secondary Outcome Measures

Median Weight Change From Baseline to Month 4
Measured in Kg
Median Weight Change From Baseline to Month 6
Measured in Kg
Mean Change in Binge Eating Scale Score From Baseline to Month 2
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Mean Change in Binge Eating Scale Score From Baseline to Month 6
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Mean Objective Binge Eating Episodes
Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6.

Full Information

First Posted
May 8, 2018
Last Updated
December 9, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03531112
Brief Title
Reducing Binge Eating to Prevent Weight Gain in Black Women
Official Title
Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to COVID-19
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating intervention, Appetite Awareness Training (AAT) to reduce binge eating and prevent weight gain for Black women with a BMI > 25 kg/m^2 and with weekly binge eating episodes. Intervention participants will receive a 8-week group AAT intervention, and will also receive bluetooth-connected scales for daily weighing. Participants will also receive tailored feedback on self-weighing frequency and weight change. The investigators will follow-up with participants at six months.
Detailed Description
Aim 1. Using an experimental design, examine the feasibility and acceptability of 6-month AAT (N=40) in North Carolina. Forty overweight and obese (BMI ≥ 25 kg/m^2) community-based Black women will be randomized to the AAT intervention or wait-list control (who will eventually receive the intervention). AAT participants will meet weekly for 8 weeks, followed by a 4-month period of daily weighing and weekly tailored feedback only. The study will examine the following: recruitment feasibility, attendance/retention, adherence, satisfaction, and barriers to completion. Aim 2: At 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms and (b) weight, blood pressure, and waist circumference for participants in the intervention vs. control group. H_1: Participants in the AAT intervention will report less binge and overeating and gain less weight than those in the control group at 2 and 6 months. Secondary aim: Examine characteristics (e.g., baseline BMI, severity of binge eating, frequency of self-weighing) related to change in binge eating and weight.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed study will use a randomized clinical trial design. A sample of 40 black women who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT intervention: AAT or a wait-list control group (delayed intervention group). AAT participants will receive an 8-week AAT program using a group format, and will be provided a smart scale (with bluetooth-connection for automatic data reporting) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessments will be conducted at 0, 2, and 6 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)
Arm Type
Experimental
Arm Description
Participants will receive an 8-week Appetite Awareness Training (AAT) program using a group format, will be provided a smart scale (with bluetooth connection) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessment will be conducted at 0, 2, and 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Intervention Type
Behavioral
Intervention Name(s)
Appetite Awareness Treatment + Lifestyle Modification
Intervention Description
The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
Primary Outcome Measure Information:
Title
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
Description
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time Frame
Month 6
Title
Feasibility (Retention): Percentage of Participants Retained in the Study
Description
Percentage of participants retained in the study following enrollment through month 6
Time Frame
Month 6
Title
Feasibility (Attendance): Percentage of Sessions That Were Attended
Description
Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100.
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Median Weight Change From Baseline to Month 4
Description
Measured in Kg
Time Frame
Baseline, Month 4
Title
Median Weight Change From Baseline to Month 6
Description
Measured in Kg
Time Frame
Baseline, Month 6
Title
Mean Change in Binge Eating Scale Score From Baseline to Month 2
Description
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time Frame
Baseline, Month 2
Title
Mean Change in Binge Eating Scale Score From Baseline to Month 6
Description
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time Frame
Baseline, Month 6
Title
Mean Objective Binge Eating Episodes
Description
Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6.
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-identify as a female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals are eligible if they are: non-Latino Black women, over 18 years of age, have a BMI ≥ 25kg/m^2, use a Bluetooth-enabled smartphone, report at least one binge eating episode weekly, and complete the screening. Exclusion Criteria: Individuals will be excluded if they: are currently pregnant, are in substance abuse treatment, are involved in another weight reduction program, have a history of anorexia, are purging, are currently in treatment for eating difficulties, are concurrent intravenous drug users or consume >4 alcoholic beverages/day.
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
Nutrition Research Institute
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Binge Eating to Prevent Weight Gain in Black Women

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