Reducing Binge Eating to Prevent Weight Gain in Black Women
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|ClinicalTrials.gov Identifier: NCT03531112|
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Binge Eating Weight Loss Weight Gain Prevention||Behavioral: Appetite Awareness Treatment||Not Applicable|
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/m²) 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 2 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study|
|Actual Study Start Date :||January 12, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Appetite Awareness Treatment
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
The goal of Appetite Awareness Treatment (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. The AAT intervention includes eight 60-minute group sessions. 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.
No Intervention: Control
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.
- Feasibility (Recruitment): Total number of participants who were eligible and enrolled in the study [ Time Frame: Month 6 ]Total number of participants who were eligible and enrolled in the study
- Feasibility (Retention): Percentage of participants retained in the study [ Time Frame: Month 6 ]Percentage of participants retained in the study following enrollment through month 6
- Feasibility (Attendance): Percentage of sessions that were attended [ Time Frame: Month 2 ]Percentage of sessions that were attended
- Percent weight change from Baseline to Month 2 [ Time Frame: Baseline, Month 2 ]Measured in Kg
- Percent weight change from Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]Measured in Kg
- Mean Change in Binge Eating Scale Score from Baseline to Month 2 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531112
|Contact: Rachel W. Goode, PhD, MPHemail@example.com|
|United States, North Carolina|
|Nutrition Research Institute||Recruiting|
|Kannapolis, North Carolina, United States, 28081|
|Contact: Jomari Torres, MD 704-250-5062|
|Principal Investigator: Rachel W. Goode, PhD, MPH|
|Principal Investigator:||Rachel Goode, PhD, MPH||University of North Carolina, Chapel Hill|