Trial Outcomes & Findings for Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating (NCT NCT04088097)
NCT ID: NCT04088097
Last Updated: 2024-10-10
Results Overview
Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Post (4 months)
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Cognitive-Behavioral Therapy
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioral Therapy
n=25 Participants
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
n=25 Participants
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.20 years
STANDARD_DEVIATION 1.66 • n=5 Participants
|
14.88 years
STANDARD_DEVIATION 1.33 • n=7 Participants
|
14.54 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non Binary
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Binge Eating Episodes
|
12.04 episodes of behavior
STANDARD_DEVIATION 9.19 • n=5 Participants
|
13.57 episodes of behavior
STANDARD_DEVIATION 19.11 • n=7 Participants
|
12.77 episodes of behavior
STANDARD_DEVIATION 14.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post (4 months)Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Outcome measures
| Measure |
Cognitive-Behavioral Therapy
n=21 Participants
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
n=19 Participants
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
|---|---|---|
|
Binge (Loss-of-control) Eating Episode Frequency
|
1.52 episodes of behavior
Standard Deviation 2.09
|
6.05 episodes of behavior
Standard Deviation 10.35
|
PRIMARY outcome
Timeframe: Post (4 months)Percent BMI change
Outcome measures
| Measure |
Cognitive-Behavioral Therapy
n=21 Participants
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
n=20 Participants
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
|---|---|---|
|
Weight (e.g., Percent Loss)
|
.02 percentage of baseline BMI
Standard Deviation .13
|
.01 percentage of baseline BMI
Standard Deviation .06
|
SECONDARY outcome
Timeframe: Short-Term Follow-Up (3 months after end of treatment)Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire)
Outcome measures
| Measure |
Cognitive-Behavioral Therapy
n=23 Participants
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
n=17 Participants
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
|---|---|---|
|
Binge (Loss-of-control) Eating Episode Frequency
|
2.04 episodes of behavior
Standard Deviation 2.92
|
5.94 episodes of behavior
Standard Deviation 9.59
|
SECONDARY outcome
Timeframe: Short-Term Follow-Up (3 months after end of treatment)Percent BMI change
Outcome measures
| Measure |
Cognitive-Behavioral Therapy
n=23 Participants
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating: Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
|
Control Condition
n=18 Participants
Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition.
|
|---|---|---|
|
Weight (e.g., Percent Loss)
|
.02 percentage of baseline BMI
Standard Deviation .14
|
.01 percentage of baseline BMI
Standard Deviation .06
|
Adverse Events
Cognitive-Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place