Binge Eating, Eating Disorders in Adolescence, Overweight and Obesity
Conditions
Keywords
adolescent, cognitive-behavioral therapy, loss of control eating
Brief summary
This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.
Detailed description
Youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. As there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. Among adults, cognitive-behavioral therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. This study will develop a new CBT treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). This study will also test the efficacy of the newly-developed CBT for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.
Interventions
BEHAVIORALCognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating
Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
OTHERControl Condition
Educational and informational materials on adolescent health and nutrition.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
To be included, adolescents must: 1. Be in the age range ≥12 years old and ≤17 years old; 2. Have a BMI that places them above the 85th percentile based on their age and sex; 3. Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months; 4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions); 5. Read, comprehend, and write English at a sufficient level to complete study-related materials; 6. Be available for participation in the study for 7 months.
Exclusion criteria
Prospective participants will be excluded if the adolescent: 1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality); 2. Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems); 3. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension); 4. Is pregnant or breastfeeding; 5. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite; 6. Began taking hormonal contraceptives less than 3 months prior; 7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder); 8. Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or 9. Is participating in another clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge (Loss-of-control) Eating Episode Frequency | Post (4 months) | Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire) |
| Weight (e.g., Percent Loss) | Post (4 months) | Percent BMI change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge (Loss-of-control) Eating Episode Frequency | Short-Term Follow-Up (3 months after end of treatment) | Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire) |
| Weight (e.g., Percent Loss) | Short-Term Follow-Up (3 months after end of treatment) | Percent BMI change |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Control Condition Educational materials related to adolescent health and nutrition.
Control Condition: Educational and informational materials on adolescent health and nutrition. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Cognitive-Behavioral Therapy | Control Condition |
|---|---|---|---|
| Age, Continuous | 14.54 years STANDARD_DEVIATION 1.53 | 14.20 years STANDARD_DEVIATION 1.66 | 14.88 years STANDARD_DEVIATION 1.33 |
| Binge Eating Episodes | 12.77 episodes of behavior STANDARD_DEVIATION 14.62 | 12.04 episodes of behavior STANDARD_DEVIATION 9.19 | 13.57 episodes of behavior STANDARD_DEVIATION 19.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 22 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 17 Participants | 18 Participants |
| Region of Enrollment United States | 50 Participants | 25 Participants | 25 Participants |
| Sex/Gender, Customized Female | 30 Participants | 17 Participants | 13 Participants |
| Sex/Gender, Customized Male | 19 Participants | 8 Participants | 11 Participants |
| Sex/Gender, Customized Non Binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Binge (Loss-of-control) Eating Episode Frequency
Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Time frame: Post (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Binge (Loss-of-control) Eating Episode Frequency | 1.52 episodes of behavior | Standard Deviation 2.09 |
| Control Condition | Binge (Loss-of-control) Eating Episode Frequency | 6.05 episodes of behavior | Standard Deviation 10.35 |
p-value: 0.01ANOVA
Primary
Weight (e.g., Percent Loss)
Percent BMI change
Time frame: Post (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Weight (e.g., Percent Loss) | .02 percentage of baseline BMI | Standard Deviation 0.13 |
| Control Condition | Weight (e.g., Percent Loss) | .01 percentage of baseline BMI | Standard Deviation 0.06 |
p-value: 0.75ANOVA
Secondary
Binge (Loss-of-control) Eating Episode Frequency
Eating episodes will be assessed by questionnaire (Eating Disorder Examination Questionnaire)
Time frame: Short-Term Follow-Up (3 months after end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Binge (Loss-of-control) Eating Episode Frequency | 2.04 episodes of behavior | Standard Deviation 2.92 |
| Control Condition | Binge (Loss-of-control) Eating Episode Frequency | 5.94 episodes of behavior | Standard Deviation 9.59 |
p-value: 0.03ANOVA
Secondary
Weight (e.g., Percent Loss)
Percent BMI change
Time frame: Short-Term Follow-Up (3 months after end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Weight (e.g., Percent Loss) | .02 percentage of baseline BMI | Standard Deviation 0.14 |
| Control Condition | Weight (e.g., Percent Loss) | .01 percentage of baseline BMI | Standard Deviation 0.06 |