Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
21. august 2018 oppdatert 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:
- Adolescents receiving bariatric surgery will demonstrate significant reductions in body weight, eating pathology, and other symptoms after receiving bariatric surgery.
- Adolescents enrolled in the bariatric surgery program will report more psychological problems than other treatment-seeking obese adolescents.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10032
- New York State Psychiatric Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adolescent Surgical Candidates, Obese Comparison Subjects, Normal-Weight Comparison Subjects
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Adolescent Surgical Candidates
Adolescents at the Center for Adolescent Bariatric Surgery, Columbia University Medical Center
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Obese Treatment-Seeking Adolescents
Obese Treatment-Seeking Adolescents, Maxcor Program for Overweight Education and Reduction (POWER) Program
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Normal-Weight Adolescents
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Psychological Symptoms
Tidsramme: 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
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The measures of psychological symptoms at each time point will include:
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment Compliance
Tidsramme: 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
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Clinician rated measures of compliance and adherence to treatment recommendations.
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Robyn Sysko, Ph.D., New York State Psychiatric Institute
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2010
Primær fullføring (Faktiske)
1. januar 2017
Studiet fullført (Faktiske)
5. januar 2017
Datoer for studieregistrering
Først innsendt
2. mars 2010
Først innsendt som oppfylte QC-kriteriene
2. mars 2010
Først lagt ut (Anslag)
3. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- #6035/#7001R
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