Clinical trial NCT01079377: Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
Official title: Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Adolescents
Bariatric Surgery
Psychological Symptoms
Cognitive Behavioral Therapy
Telemedicine
Longitudinal
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent Surgical Candidates, Obese Comparison Subjects, Normal-Weight Comparison Subjects

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Psychological Symptoms
timeFrame: 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
timeFrame: 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
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Robyn Sysko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: