NCT01079377

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. 1.Adolescents receiving bariatric surgery will demonstrate significant reductions in body weight, eating pathology, and other symptoms after receiving bariatric surgery.
  2. 2.Adolescents enrolled in the bariatric surgery program will report more psychological problems than other treatment-seeking obese adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2017

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

7 years

First QC Date

March 2, 2010

Last Update Submit

August 21, 2018

Conditions

Obesity

Keywords

AdolescentsBariatric SurgeryPsychological SymptomsCognitive Behavioral TherapyTelemedicineLongitudinal

Outcome Measures

Primary Outcomes (1)

  • Psychological Symptoms

    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.

    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 (1)

  • Treatment Compliance

    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

Study Arms (3)

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

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ \< 70)
  • CONTROL GROUP (obese treatment-seeking adolescents)
  • 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
  • DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ \< 70)
  • CONTROL GROUP (normal-weight adolescents)
  • body mass index between 25th and 85th percentile for sex
  • between the ages of 14 and 18
  • adolescents speak English
  • parents speak English
  • DSM-IV Diagnosis of Mild, Moderate, or Severe Mental Retardation (e.g., IQ \< 70)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robyn Sysko, Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 3, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2017

Study Completion

January 5, 2017

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

US(1)