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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
North Dakota
-
Fargo, North Dakota, Estados Unidos, 58103
- Neuropsychiatric Research Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Psychopathology as measured by the SCID
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Quality of life as measured by the IWQOL
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Affect regulation as measured by the DERS
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: James E. Mitchell, MD, Neuropsychiatric Research Institute
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 5R01DK084979-06 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .