Psychosocial Issues and Bariatric Surgery (LABS3)
Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Although no robust predictors of response have been identified, pilot data that will be presented and reviewed suggest that surgery has profound effects on eating behaviors and psychosocial functioning, and that these factors may affect postoperative weight control.
The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery among a geographically, ethnically, and racially diverse sample of men and women undergoing bariatric surgery. This project unites experts in the areas of psychopathology, eating behaviors and quality of life to conduct a naturalistic study using state-of-the-art assessment tools; to document the relationships among psychosocial factors; and to examine psychosocial predictors of surgical outcomes.
A tanulmány áttekintése
Állapot
Részletes leírás
Primary Objective. Despite the obvious impact of bariatric surgery procedures on intake, no study to date has included a careful assessment of psychological factors, feeding patterns, energy intake and eating problems in this group of patients longitudinally. The Investigators believe that a careful examination of the structure of eating behavior and eating problems (e.g. vomiting) would be very helpful in guiding bariatric surgeons and dieticians who work with this group of patients in terms of dietary advice and recommendations, and with the prediction of eating problems and poor nutrient intake in the subgroup that develops such problems. This study involves prospective assessment of psychosocial outcomes of surgery by adding a supplemental battery to the LABS-2 assessment schedule. Conducting assessments at three of the LABS clinical sites assures the geographic, ethnic, and racial diversity of the sample, and hence enhances the potential to identify a subgroup or subgroups of patients susceptible to poor outcomes after surgery and the generalizability of study results.
This study would also include an evaluation of psychopathological and behavioral variables that might impact on weight loss and weight regain, and psychosocial complications post-operatively, as well as quality of life.
The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for up to 7 years after the surgical intervention.
The Investigators believe that the instruments and procedures selected will allow a detailed examination of psychopathology, eating pathology and quality of life in detail.
The Investigators believe that the measures and tasks added at year 7 will allow the examination of theories of affect regulation, cognitive control, and reward processing in understanding postsurgical outcomes regarding pathological eating behavior and alcohol/substance use and their shared similarities as well as underlying neurobiological systems.
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
-
-
North Dakota
-
Fargo, North Dakota, Egyesült Államok, 58103
- Neuropsychiatric Research Institute
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- Previous enrollment in LABS-1 and LABS-2.
- BMI at baseline of greater than or equal to 35.
Exclusion Criteria:
- Informed consent not obtained
- Type 1 Diabetes Mellitus
- Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits)
- Unable to communicate with local study staff
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Psychopathology as measured by the SCID
Időkeret: annually up to 7 years post bariatric surgery
|
Structured Clinical Interview for DSM-IV, Patients Edition (SCID) will be administered to assess comorbid Axis I psychopathology.
|
annually up to 7 years post bariatric surgery
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Quality of life as measured by the IWQOL
Időkeret: annually up to 7 years post bariatric surgery
|
Impact of Weight on Quality of Life Questionnaire: This is a 31-item, self-report, obesity-specific quality of life measure that will be utilized to assess quality of life.
|
annually up to 7 years post bariatric surgery
|
|
Change in Quality of life as measured by the SF-36
Időkeret: annually up to 7 years post bariatric surgery
|
ShortForm-36: The SF-36 is a 36-item questionnaire that assesses functioning and quality of life as it relates to health status.
|
annually up to 7 years post bariatric surgery
|
|
Change in Depression as measured by the BDI
Időkeret: annually up to 7 years post bariatric surgery
|
Beck Depression Inventory: The BDI is a 21-item instrument that is widely used to assess depressive symptoms.
|
annually up to 7 years post bariatric surgery
|
|
Change in Eating behaviors as measured by the EDE
Időkeret: annually up to 7 years post bariatric surgery
|
Eating Disorder Examination: The diagnostic version of the EDE will be used as the primary measure of eating behavior and pathology.
|
annually up to 7 years post bariatric surgery
|
|
Change in Impulse Control as measured by the SCID-ICD module
Időkeret: annually up to 7 years post bariatric surgery
|
The impulse control module of the SCID will be administered to assess impulsive/compulsive disorders for participants.
|
annually up to 7 years post bariatric surgery
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Affect regulation as measured by the DERS
Időkeret: 7 year post bariatric surgery
|
Difficulties in Emotion Regulation Scale: The DERS is a 36-item self-report questionnaire that assesses six domains of emotion dysregulation and has been found to have acceptable internal consistency as well as adequate test-retest reliability and construct validity.
|
7 year post bariatric surgery
|
|
Affect regulation as measured by the AIM
Időkeret: 7 years post bariatric surgery
|
Affect Intensity Measure:The AIM is a 40-item self-report measure of positive and negative emotional intensity and reactivity.
|
7 years post bariatric surgery
|
|
Impulsivity
Időkeret: 7 years post bariatric surgery
|
UPPS-P Impulsive Behavior Scale: This is a 59-item self-report measure assessing five dimensions of impulsivity.
Only the negative urgency and positive urgency subscales will be administered.
|
7 years post bariatric surgery
|
|
Behavioral inhibition as measured by the SPSRQ
Időkeret: 7 years post bariatric surgery
|
Sensitivity to Punishment and Sensitivity to Reward Questionnaire: This is a 44-item self-report measure that is based on Gray's behavioral inhibition and activation motivational systems conceptualization, and assesses sensitivity to punishment and reward.
|
7 years post bariatric surgery
|
|
Temperament as measured by the ATQ
Időkeret: 7 years post bariatric surgery
|
Effortful Control Scale of the Adult Temperament Questionnaire: This 19-item self-report measure assesses several components of dispositional effortful control, including attentional control (i.e., ability to voluntarily focus or shift attention), inhibitory control (i.e., ability to inhibit behavior), and activation control (i.e., ability to activate behavior as needed).
|
7 years post bariatric surgery
|
|
Cognitive Control as measured by the Go/No-Go Task
Időkeret: 7 years post bariatric surgery
|
Go/No-Go Task: This computerized task assesses the capacity for suppressing previously reinforced responses.
|
7 years post bariatric surgery
|
|
Cognitive Control as measured by the Delay Discounting Task
Időkeret: 7 years post bariatric surgery
|
Delay Discounting Task: Delay discounting tasks require participants to choose between receiving a larger amount of money after a delay versus receiving a smaller amount immediately.
|
7 years post bariatric surgery
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: James E. Mitchell, MD, Neuropsychiatric Research Institute
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 5R01DK084979-06 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Depressziós rendellenesség
-
Hôpital le VinatierMég nincs toborzásBorderline Personality Disorder BPDFranciaország
-
Corestemchemon, Inc.Még nincs toborzásNeuromyelitis Optica Spectrum Disorder Relapszus
-
Linkoeping UniversityBefejezveWhiplash Associated DisorderSvédország
-
University of CalgaryVivo Cura HealthToborzásWhiplash Associated Disorder (WAD)Kanada
-
University Hospitals, LeicesterBefejezveWhiplash Associated DisorderEgyesült Királyság
-
Kyunghee University Medical CenterUniversity of TsukubaBefejezveWhiplash Associated Disorder (WAD)Koreai Köztársaság
-
University Hospital, Strasbourg, FranceMég nincs toborzásAutizmus spektrum zavar | Borderline Personality Disorder BPD | a Premenstruális Diszfóriás Zavar (PMDD)
-
Uskudar UniversityBeykoz University; Istanbul Nisantasi UniversityAktív, nem toborzóTesti diszmorf rendellenesség | Szteroid visszaélés | Body Dismorphic Disorder (BDD), Altípus: IzomdiszmorfiaPulyka
-
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.Még nincs toborzásNeuromyelitis Optica Spectrum Disorder (NMOSD)
-
Samsung Medical CenterBefejezveNeuromyelitis Optica Spectrum Disorder (NMOSD)