Reducing Binge Eating to Prevent Weight Gain in Black Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Binge Eating, Weight Loss, Weight Gain Prevention

Intervention / Treatment
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* Behavioral: Appetite Awareness Treatment + Lifestyle Modification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)<br>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. | Behavioral: Appetite Awareness Treatment + Lifestyle Modification<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Feasibility (Retention): Percentage of Participants Retained in the Study | Percentage of participants retained in the study following enrollment through month 6 | 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. | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Weight Change From Baseline to Month 4 | Measured in Kg | Baseline, Month 4 | 
| Median Weight Change From Baseline to Month 6 | Measured in Kg | Baseline, Month 6 | 
| 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 | 
| 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 | 
| 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 |