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

NCT03404713 | Terminated

• 1 other identifier: HM20010755
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 adolescents with overweight/obesity and loss of control (LOC) eating supports a stepped-care model of treatment in which enhanced behavioral weight loss treatment is the first line of treatment followed by more intensive therapeutic treatment for individuals with remaining emotional eating difficulties. Thus, in this proposed study, the investigators will systematically develop a stepped-care protocol and manualized interventions for adolescents with LOC and binge eating behaviors. The investigators will then evaluate the feasibility and acceptability of the interventions in a pilot trial and gather preliminary outcome data to inform development of a subsequent randomized controlled trial.

Conditions

Overweight and Obesity; Pediatric Obesity; Eating, Binge

Keywords

adolescence; adolescent; binge eating; loss-of-control eating; behavioral weight loss; weight management; acceptance commitment therapy; overweight; obesity

Outcome Measures

Primary Outcomes (1)

• Change in objective and subjective binge and loss-of-control eating episodes as measured by the Eating Disorder Examination

  The overeating module of the Eating Disorder Examination (EDE) assesses frequency of adolescents' objective and subjective binge and loss-of-control eating episodes during the last 28 days. Change in frequency of these episodes from baseline will be assessed at 4 weeks and 16 weeks.

  Baseline, mid-treatment (4 weeks), and end of treatment (16 weeks)

Secondary Outcomes (3)

• Change in emotional eating as measured by the Emotional Eating Scale for Adolescents Questionnaire

  Baseline, mid-treatment (4 weeks), and end of treatment (16 weeks)

• Change in anxiety and depressive symptoms as measured by the Revised Child Anxiety and Depression scales

  Baseline, mid-treatment (4 weeks), and end of treatment (16 weeks)

• Change in self-esteem as measured by the Rosenberg Self-Esteem Scale

  Baseline, mid-treatment (4 weeks), and end of treatment (16 weeks)

Study Arms (2)

Standard Behavioral Weight Loss (BWL) Treatment

ACTIVE COMPARATOR

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.

Behavioral: Pathways to Health

Acceptance-Based Binge Eating Treatment

EXPERIMENTAL

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.

Behavioral: Pathways to Health; Behavioral: Be4U

Interventions

Pathways to Health BEHAVIORAL

Manualized sessions will follow an acceptance based behavioral weight loss treatment approach, including guided goal-setting and self-monitoring, identifying barriers and solutions, contingency management, stimulus control, dealing with setbacks and relapse prevention. Daily food and physical activity are logged and monitored. Parents learn strategies to support and facilitate their child's weight management via family-based change.

Acceptance-Based Binge Eating Treatment; Standard Behavioral Weight Loss (BWL) Treatment

Be4U BEHAVIORAL

This intervention is grounded in Cognitive Behavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), and Acceptance and Commitment Therapy (ACT). The core elements include regulating eating patterns, self-monitoring, developing openness to an acceptance perspective, fostering a willingness to accept distress, teaching defusion from distressing thoughts and feelings, practicing mindful awareness, fostering self-as-context, and directing patients towards clarifying and focusing on life values. Self-monitoring of eating behaviors and emotions are encouraged using a free app that facilitates electronic self-monitoring of eating patterns and symptoms. For participants who elect not to use this app, paper self-monitoring records are provided.

Also known as: Acceptance-Based Binge Eating Intervention (ABBT)

Acceptance-Based Binge Eating Treatment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Pediatric Obesity; Bulimia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Study Officials

• Rachel W Gow, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each eligible participant receives the same standard group treatment for the first four weeks. Early responders continue in that treatment for an additional 12 weeks. Early weak responders are assigned to a higher intensity individualized treatment for the next 12 weeks.

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 19, 2018
• Study Start: February 15, 2018
• Primary Completion: September 10, 2018
• Study Completion: November 7, 2018
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)