Status:
TERMINATED
Evaluating the Feasibility of a Stepped-care Approach to Treating Adolescents With Binge and Loss of Control Eating
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Overweight and Obesity
Pediatric Obesity
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
There are limited evidence-based treatments for adolescents with binge eating and fewer specifically targeting adolescents with both binge eating and overweight/obesity. The existing research for adol...
Detailed Description
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 ha...
Eligibility Criteria
Inclusion
- Adolescent
- 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
- 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
- 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
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03404713
Start Date
February 15 2018
End Date
November 7 2018
Last Update
October 15 2024
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298