Reducing Binge Eating to Prevent Weight Gain in Black Women

Not Applicable

Terminated

• Conditions: Binge Eating; Weight Loss; Weight Gain Prevention
• Interventions: Behavioral: Appetite Awareness Treatment + Lifestyle Modification

• Registration Number: NCT03531112
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-21
• Study Start: 2019-01-12
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Status Verified: 2021-07
• Results First Submitted: 2021-09-30
• Results First Submitted QC: 2021-11-10
• Results First Posted: 2021-12-09
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)	Appetite Awareness Treatment + Lifestyle Modification	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.

Primary Outcome Measures

Name	Time	Method
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study	Month 6	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	Month 6	Percentage of participants retained in the study following enrollment through month 6
Feasibility (Attendance): Percentage of Sessions That Were Attended	Month 2	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

Name	Time	Method
Median Weight Change From Baseline to Month 6	Baseline, Month 6	Measured in Kg
Median Weight Change From Baseline to Month 4	Baseline, Month 4	Measured in Kg
Mean Objective Binge Eating Episodes	up to 6 months	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.
Mean Change in Binge Eating Scale Score From Baseline to Month 2	Baseline, 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	Baseline, 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.

Trial Locations

Locations (1)

Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States