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临床试验/NCT01079377
NCT01079377已完成不适用

Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Psychological Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Psychological Symptoms

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leora David

Research Scientist

New York State Psychiatric Institute

研究点 (1)

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