Evaluating the Feasibility of a Stepped-care Approach to Treating Adolescents With Binge and Loss of Control Eating
Overweight and Obesity, Pediatric Obesity, Eating, Binge
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring adolescence, adolescent, binge eating, loss-of-control eating, behavioral weight loss, weight management, acceptance commitment therapy, overweight, obesity
Eligibility Criteria
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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Behavioral Weight Loss (BWL) Treatment
Acceptance-Based Binge Eating Treatment
All participants will participate in 4 weeks of group based behavioral weight lost treatment in the intervention called Pathways to Health. Based on early treatment response (improvement in binge eating), participants will be assigned to either continue in this arm for the remaining 12 weeks of treatment (early strong responders) or be assigned to the 2nd arm of this study.
After 4 weeks of standard BWL treatment, early weak responders will be assigned to individual acceptance-based treatment for the remaining 12 weeks of treatment.