Evaluating the Feasibility of a Stepped-care Approach to Treating Adolescents With Binge and Loss of Control Eating

Binge eating affects a significant number of adolescents. Among adolescents seeking obesity
treatment, rates of binge eating behavior range from 20-36%. Studies of non-treatment seeking
adolescents have also identified high rates of binge eating, suggesting that this behavior is
not exclusive to clinical samples. Moreover, as in adults, binge eating in youth is
associated with numerous psychosocial problems, including depression, anxiety, low
self-esteem, body dissatisfaction and weight concern.

Stepped-care models provide a lower intensity treatment and modify subsequent treatment
intensity based on early treatment response. A stepped-care model would build upon the
clinical treatment resources already established at the study site.

In this study, the investigators will conduct a small pilot of the stepped-care model. All
participants will begin with the same initial treatment, an introductory behavioral weight
loss group for parents and adolescents with abnormal weight gain and/or overweight/obesity.
Early responders will continue in this treatment for an additional 12 weeks. Participants who
show a weaker early response will be assigned to a higher intensity individualized treatment.
All participants will receive 16 weeks of treatment.Assessments will occur at three time
points: prior to intervention (baseline), mid-treatment (4 weeks), and end of treatment (16
weeks). The investigators will assess the feasibility, acceptability, and preliminary
effectiveness of the stepped care approach. These data will inform the development of a
subsequent RCT.

Adolescent Inclusion Criteria:

- Overweight (BMI ≥85% percentile for age and gender according to the CDC Growth Charts)

- Males and females ages 13 to 18 years

- Must endorse loss of control (LOC) eating

- Adolescent must reside with the primary participating caregiver who is also willing to
participate in the study

Caregiver Inclusion Criteria:

- Participating caregiver must be at least 18 years of age

- Participating caregiver must reside with the adolescent

- Participating caregiver must be willing to participate in the standard intervention

- Participating caregiver may be another relative (i.e., grandparents) or legal guardian
as long as he/she resides with the adolescent and has primary responsibility for the
child.

Adolescent Exclusion Criteria:

- Non-English speaking

- Medical condition(s) that may be associated with unintentional weight change (e.g.,
hypothalamic injury, Prader Willi, or malignancy)

- Uncontrolled diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl
(subjects with glucose intolerance or "prediabetes" will be eligible for study
participation)

- Use of oral glucocorticoids, atypical antipsychotics, weight loss medications,
diuretic medication or an investigational medication within 3 months of study
participation

- Medical condition(s) that may be negatively impacted by exercise

- Psychiatric, cognitive, physical or developmental conditions that would impair the
adolescent's ability to complete assessments, participate in a group, or conduct
physical activity

- Reports of compensatory behaviors (i.e., vomiting, laxative, abuse, excessive
exercise) in the past 3 months

- Current pregnancy or plan to become pregnant during study period

- Previous participation in Clinical Trials #(INSERT)

- Current participation in another weight loss program

- Personal history of weight loss surgery

- Weight in excess of 400 pounds

- Admission to a psychiatric hospital within the past year.

In addition, adolescents will be excluded from participation (and referred for further
evaluation) based on the results of baseline psychological assessments under the following
circumstances: 1) clinically significant depression, evidenced RCADS or or during screening
/ behavioral interview; 2) active suicidality as reported on surveys or during screening /
behavioral interview; 3) clinically significant eating disorder based on assessments or
during screening/behavioral interview.

Adolescents taking metformin, oral contraceptives, tricyclic antidepressants (TCAs),
selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be eligible
for participation; however, subjects must be on a stable dose of medication for at least 3
months prior to study participation.

Caregiver Exclusion Criteria:

- Non-English speaking

- Psychiatric, cognitive, physical or developmental conditions that would impair the
parent's ability to respond to assessments or support adolescent's participation.

In the event that a participant is deemed eligible to participate based on initial
criteria, but subsequently develops a condition listed for exclusion after participation in
the study has begun, the investigative team will review the specific case to assess the
impact of the newly discovered condition on the subject's ability to safely continue
participation and the quality of the data that will be collected from the subject.