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Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

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ClinicalTrials.gov Identifier: NCT01079377
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease
Obesity

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.

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
Study Start Date : January 2010
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 5, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Adolescent Surgical Candidates
Adolescents at the Center for Adolescent Bariatric Surgery, Columbia University Medical Center
Obese Treatment-Seeking Adolescents
Obese Treatment-Seeking Adolescents, Maxcor Program for Overweight Education and Reduction (POWER) Program
Normal-Weight Adolescents
Normal-Weight Adolescents



Primary Outcome Measures :
  1. 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 ]

    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 :
  1. 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 ]
    Clinician rated measures of compliance and adherence to treatment recommendations.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01079377     History of Changes
Other Study ID Numbers: #6035/#7001R
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

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