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Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program

21 augusti 2018 uppdaterad av: Leora David, New York State Psychiatric Institute

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • New York, New York, Förenta staterna, 10032
        • New York State Psychiatric Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Psychological Symptoms
Tidsram: 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.
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Compliance
Tidsram: 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.
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Robyn Sysko, Ph.D., New York State Psychiatric Institute

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 januari 2017

Avslutad studie (Faktisk)

5 januari 2017

Studieregistreringsdatum

Först inskickad

2 mars 2010

Först inskickad som uppfyllde QC-kriterierna

2 mars 2010

Första postat (Uppskatta)

3 mars 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

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