- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531112
Reducing Binge Eating to Prevent Weight Gain in Black Women
Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Kannapolis, North Carolina, United States, 28081
- Nutrition Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
Time Frame: 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.
|
Month 6
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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
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Month 6
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Feasibility (Attendance): Percentage of Sessions That Were Attended
Time Frame: 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.
|
Month 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Weight Change From Baseline to Month 4
Time Frame: Baseline, Month 4
|
Measured in Kg
|
Baseline, Month 4
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Median Weight Change From Baseline to Month 6
Time Frame: Baseline, Month 6
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Measured in Kg
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Baseline, Month 6
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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.
|
Baseline, Month 2
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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.
|
Baseline, Month 6
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Mean Objective Binge Eating Episodes
Time Frame: up to 6 months
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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.
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up to 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0784
- P30DK056350 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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