Trial Outcomes & Findings for Reducing Binge Eating to Prevent Weight Gain in Black Women (NCT NCT03531112)
NCT ID: NCT03531112
Last Updated: 2021-12-17
Results Overview
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
TERMINATED
NA
20 participants
Month 6
2021-12-17
Participant Flow
Study terminated prior to enrollment of control participants.
Participant milestones
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM): 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
0
|
|
Overall Study
Month 4
|
17
|
0
|
|
Overall Study
Month 6 (Follow-Up)
|
13
|
0
|
|
Overall Study
COMPLETED
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Binge Eating to Prevent Weight Gain in Black Women
Baseline characteristics by cohort
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=20 Participants
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.
|
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
—
|
46.4 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
—
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
—
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
—
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
—
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Study terminated prior to enrollment of control participants. The number of potential participants screened for study eligibility
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=30 Participants
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.
|
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
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: Study terminated prior to enrollment of control participants.
Percentage of participants retained in the study following enrollment through month 6
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=20 Participants
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.
|
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 (Retention): Percentage of Participants Retained in the Study
|
85 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Month 2Population: Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.
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.
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=17 Participants
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.
|
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 (Attendance): Percentage of Sessions That Were Attended
|
56 percentage of sessions per participant
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.
Measured in Kg
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=17 Participants
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.
|
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.
|
|---|---|---|
|
Median Weight Change From Baseline to Month 4
|
0 Kg
Interval -1.1 to 1.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Study terminated prior to enrollment of control participants. Data not included for seven participants who discontinued.
Measured in Kg
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=13 Participants
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.
|
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.
|
|---|---|---|
|
Median Weight Change From Baseline to Month 6
|
-0.2 Kg
Interval -0.9 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 2Population: Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Study terminated prior to enrollment of control participants.
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.
Outcome measures
| Measure |
Appetite Awareness Treatment + Lifestyle Modification
n=17 Participants
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.
|
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.
|
|---|---|---|
|
Mean Objective Binge Eating Episodes
Baseline
|
6.5 binge eating episodes
Standard Deviation 7.8
|
—
|
|
Mean Objective Binge Eating Episodes
Month 4
|
2.1 binge eating episodes
Standard Deviation 5.1
|
—
|
|
Mean Objective Binge Eating Episodes
Month 6
|
2.6 binge eating episodes
Standard Deviation 6.9
|
—
|
Adverse Events
Appetite Awareness Treatment + Lifestyle Modification
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rachel Goode, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place