Trial Outcomes & Findings for Reducing Binge Eating to Prevent Weight Gain in Black Women (NCT 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.

Recruitment status

TERMINATED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Month 6

Results posted on

2021-12-17

Participant Flow

Study terminated prior to enrollment of control participants.

Participant milestones

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

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=5 Participants	—	46.4 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	—	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	—	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	—	20 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	—	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: 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

Outcome measures
Measure	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.	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.
Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study	—	20 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Study terminated prior to enrollment of control participants.

Percentage of participants retained in the study following enrollment through month 6

Outcome measures

Outcome measures
Measure	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.	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.
Feasibility (Retention): Percentage of Participants Retained in the Study	—	85 percentage of participants

PRIMARY outcome

Timeframe: Month 2

Population: 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

Outcome measures
Measure	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.	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.
Feasibility (Attendance): Percentage of Sessions That Were Attended	—	56 percentage of sessions per participant

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.

Measured in Kg

Outcome measures

Outcome measures
Measure	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.	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.
Median Weight Change From Baseline to Month 4	—	0 Kg Interval -1.1 to 1.4

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Study terminated prior to enrollment of control participants. Data not included for seven participants who discontinued.

Measured in Kg

Outcome measures

Outcome measures
Measure	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.	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.
Median Weight Change From Baseline to Month 6	—	-0.2 Kg Interval -0.9 to 0.5

SECONDARY outcome

Timeframe: Baseline, Month 2

Population: 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 6

Population: 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 months

Population: 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

Outcome measures
Measure	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.	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.
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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 919-962-6429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place