Overview

This trial is active, not recruiting.

Condition obesity
Sponsor New York State Psychiatric Institute
Start date January 2010
End date December 2016
Trial size 186 participants
Trial identifier NCT01079377, #6035/#7001R

Summary

This study will examine the interaction of psychological factors and serious overweight to determine if particular patterns of psychological symptoms are helpful in predicting outcomes of weight loss surgery.

Patients from the Center of Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal prospective study of psychopathology among severely obese adolescents. Additionally, the psychological symptoms of this group will be compared to other treatment-seeking obese adolescents.

The investigators hypothesize that:

1. Adolescents receiving bariatric surgery will demonstrate significant reductions in body weight, eating pathology, and other symptoms after receiving bariatric surgery.

2. Adolescents enrolled in the bariatric surgery program will report more psychological problems than other treatment-seeking obese adolescents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Adolescents at the Center for Adolescent Bariatric Surgery, Columbia University Medical Center

Primary Outcomes

Measure
Psychological Symptoms
time frame: 8 assessment points: (1) baseline pre-surgery, (2) 2 weeks pre-surgery, (3) 3 months post-surgery, (4) 6 months post-surgery, (5) 9 months post-surgery, (6) 12 months post-surgery, (7) 18 months post-surgery, (8) 24 months post-surgery

Secondary Outcomes

Measure
Treatment Compliance
time frame: 8 assessment points: (1) Baseline pre-surgery, (2) 2 weeks pre-surgery, (3) 3 months post-surgery, (4) 6 months post-surgery, (5) 9 months post-surgery, (6) 12 months post-surgery, (7) 18 months post-surgery, (8) 12 months post-surgery

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

Longitudinal assessments: Inclusion Criteria: - enrolled in the Center for Adolescent Bariatric Surgery (CABS) at the Morgan Stanley Children's Hospital of New York Presbyterian - entered the CABS program between the ages of 12 and 17, between the ages of 12 and 18 when entering the study - adolescents speak English - parents speak English or Spanish Exclusion Criteria: - DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ < 70) CONTROL GROUP (obese treatment-seeking adolescents) Inclusion Criteria: - enrolled in the Maxcor Program for Overweight Education and Reduction (POWER) Program - Between the ages of 14 and 18 - adolescents speak English - parents speak English or Spanish Exclusion Criteria: - DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ < 70) CONTROL GROUP (normal-weight adolescents) Inclusion Criteria: - body mass index between 25th and 85th percentile for sex - between the ages of 14 and 18 - adolescents speak English - parents speak English Exclusion Criteria: - DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ < 70)

Additional Information

Official title Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
Principal investigator Robyn Sysko, Ph.D.
Description With increasing rates of overweight and obesity among children and adolescents in the United States, there is an urgent need for effective weight loss treatments for younger patients. Recently, bariatric surgery has been considered as a treatment for seriously overweight adolescents because of the potential for substantial decreases in weight and subsequent improvements in physical health. This study will examine the interaction of psychological factors and serious overweight to determine if particular patterns of psychological symptoms (psychological phenotypes) are helpful in predicting outcomes of bariatric surgery. Patients from the Center for Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal prospective study of psychopathology among severely obese adolescents. The final aim of this project is to compare psychological symptoms between obese adolescents seeking bariatric surgery, other treatment-seeking obese adolescents, and normal-weight comparison adolescents. We will evaluate the effect of psychiatric symptoms on adherence to postsurgery follow-up appointments and weight loss. This research will be broadly applicable to the study of interactions between psychological factors and compliance with treatment for youth with chronic health conditions.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.