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Psychosocial Issues and Bariatric Surgery (LABS3)

19 augustus 2019 bijgewerkt door: Neuropsychiatric Research Institute, Fargo, North Dakota

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

202

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58103
        • Neuropsychiatric Research Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients will be approached for inclusion into LABS1 and LABS2 at the Sanford Surgery Department, Fargo ND, at the University of Pittsburgh Medical Center and at Cornell/Columbia Medical Center in New York. LABS3 Psychosocial participants will be selected from those individuals participating in LABS1 and LABS2.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Psychopathology as measured by the SCID
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Quality of life as measured by the IWQOL
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Affect regulation as measured by the DERS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Neuropsychiatric Research Institute, Fargo, North Dakota

Medewerkers

Columbia University
University of Pittsburgh
Duquesne University

Onderzoekers

  • Hoofdonderzoeker: James E. Mitchell, MD, Neuropsychiatric Research Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2010

Primaire voltooiing (Werkelijk)

30 juni 2019

Studie voltooiing (Werkelijk)

30 juni 2019

Studieregistratiedata

Eerst ingediend

6 juli 2015

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2015

Eerst geplaatst (Schatting)

13 juli 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2019

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2019

Laatst geverifieerd

1 augustus 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 5R01DK084979-06 (Subsidie/contract van de Amerikaanse NIH)

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