Reducing Binge Eating to Prevent Weight Gain in Black Women

Weight Loss Clinical Trial

Official title:

Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03531112
• Other study ID #: 18-0784
• Secondary ID: P30DK056350
• Status: Terminated
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: July 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Body Weight
• Bulimia
• Weight Gain
• Weight Gain Prevention
• Weight Loss

Intervention

Behavioral:
• Appetite Awareness Treatment + Lifestyle Modification
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.

Locations

Country	Name	City	State
United States	Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 6
Primary	Feasibility (Retention): Percentage of Participants Retained in the Study	Percentage of participants retained in the study following enrollment through month 6	Month 6
Primary	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.	Month 2
Secondary	Median Weight Change From Baseline to Month 4	Measured in Kg	Baseline, Month 4
Secondary	Median Weight Change From Baseline to Month 6	Measured in Kg	Baseline, Month 6
Secondary	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.	Baseline, Month 2
Secondary	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.	Baseline, Month 6
Secondary	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.	up to 6 months