Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01079377
First received: March 2, 2010
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    The measures of psychological symptoms at each time point will include:

    1. Eating and Activity Measures
    2. Depressive Symptom Measures
    3. Impulsivity Measures
    4. Measures of other relevant factors, including body mass index, family functioning, and quality of life.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Clinician rated measures of compliance and adherence to treatment recommendations.


Estimated Enrollment: 186
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adolescent Surgical Candidates
Adolescents at the Center for Adolescent Bariatric Surgery, Columbia University Medical Center

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescent Surgical Candidates, Obese Comparison Subjects, Normal-Weight Comparison Subjects

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079377

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Robyn Sysko, Ph.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01079377     History of Changes
Other Study ID Numbers: #6035/#7001R
Study First Received: March 2, 2010
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Adolescents
Bariatric Surgery
Psychological Symptoms
Cognitive Behavioral Therapy
Telemedicine
Longitudinal

ClinicalTrials.gov processed this record on October 20, 2014