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Eating Behavior, Food Craving and Relation to Excessive Weight Gain in Patients Submitted to Liver Transplantation

19 gennaio 2018 aggiornato da: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
Excessive weight gain, obesity and metabolic syndrome are highly prevalent in patients undergoing liver transplantation. Traditional methods of assessing dietary intake have failed to demonstrate an association between these problems and dietary intake. Patients with an indication for transplantation due to ethanolic cirrhosis, ex-smokers and those with a previous history of overweight were identified as being at greater risk for overweight and metabolic syndrome, and these factors may be related to the change in eating behavior after the operation. Objective: To evaluate the eating behavior, the occurrence of food craving and relation to weight gain, overweight and obesity after liver transplantation. Method: This is a cross-sectional study in which adult and elderly patients in follow-up at the Hepatic Transplant Outpatient Clinic of the Alpha Institute of Gastroenterology of the Federal University of Minas Gerais were evaluated for eating behavior and food craving. The evaluation of the eating behavior was performed with the help of the Three Factor Eating Questionnaire-R21 (TFEQ-R21), translated version and validated for Portuguese. Food Craving Questionnaires State (FCQ-S) and Trait (FCQ-T) and the Brazilian Inventory of Foods Related to Craving (FCI-Br) were used in the translated and validated versions for Portuguese. Demographic, lifestyle, clinical and anthropometric variables of the evaluated patients were obtained through electronic medical records. Weight gain was assessed by the difference between the current weight and the first post-transplant outpatient weight.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

301

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Brasile
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasile
        • Hospital of Clinics of the University Federal of Minas Gerais

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients who undergone liver transplantation at least 18 years of age, who were regularly followed up at the Bias Fortes outpatient clinic

Descrizione

Inclusion Criteria:

  • Patients who undergone liver transplantation
  • At least 18 years of age
  • Patients regularly followed up at the Bias Fortes outpatient clinic
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Patients who were unable to write and who did not have an accompanying person present as a literate person
  • Pregnant or nursing women

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Altro
  • Prospettive temporali: Trasversale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Eating behavior
Lasso di tempo: 40 minutes
The evaluation of the eating behavior was performed with the help of the Three Factor Eating Questionnaire-R21 (TFEQ-R21), translated version and validated for Portuguese. This is a self-report questionnaire composed of 21 items, with 4 response options for questions 1 to 20 and question 21 is evaluated on a likert 8-point scale. TFEQ-R21 evaluates 3 types of eating behavior: cognitive restriction (CR), emotional eating (EE) and uncontrolled eating (UE). The CR scale assesses the tendency to control food intake in order to influence body weight and body shape, with 6 items in scale. The EE scale measures the propensity to overeat in relation to negative mood states, e.g., when feeling lonely, anxious, or depressed, has 6 items. The UE scale assesses the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, has 9 of items in scale. Each score ranges from 0 to 100, with higher score indicative of greater level in the eating behavior of interest.
40 minutes

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Food Craving Questionnaires State (FCQ-S)
Lasso di tempo: 20 minutes
The FCQ-State consists of 15 questions, grouped into five dimensions: An intense desire to eat (Desire); anticipation of positive reinforcement that may result from eating (Pos R); anticipation of relief from negative states and feelings as a result of eating (Neg R); thoughts of preoccupation with food and lack of control over eating (Lack Co); and craving as part of the sensation of hunger, a physiological state (Hunger). Participants must answer each question related to what they are feeling at the moment, using a Likert scale of five points, the extremes of which are "(1) strongly disagree" and "(5) strongly agree". The full-scale score corresponds to the sum of the scores obtained in each dimension, which is calculated by simply adding them. Total scores can vary from 15 to 75.
20 minutes
Food Craving Questionnaires Trait (FCQ-T)
Lasso di tempo: 20 minutes
consume food (Plan); environmental cues that may trigger food craving (Environ); thoughts or preoccupation with food (Thoughts); craving as a physiological state (Hunger); possible lack of control over eating if food is being eaten (Lack Co); emotions that may be experienced before or during food cravings or eating (Emotion); and guilt that may be experienced because of cravings and/or giving in to them (Guilt). The answers are recorded on a Likert scale, ranging from "(1) never or not applicable" to "(6) Always," referring to the frequency with each statement applies to the participant. Full-scale and factor-scale totals are obtained by the sum of the corresponding item scores. Thus, the overall score can range from 39 to 234.
20 minutes
Brazilian Inventory of Foods Related to Craving (FCI-Br)
Lasso di tempo: 20 minutes
The Brazilian Inventory of Foods Related to Craving (FCI-Br) begins with a short definition of food cravings behavior, followed by the question ''Over the past month, how often have you experienced a craving for the food listed below?''. Each of the foods listed was evaluated using a five point Likert scale ranging from: "(1) never" to "(5) almost every day". The total score of each FCI-Br subscale was calculated by adding the scores obtained for each item that comprised it.
20 minutes

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Demographic, lifestyle, clinical and anthropometric variables
Lasso di tempo: 40 minutes
Own Checklist - Demographic variables as well as habitual life style, clinical and anthropometric characteristics were assessed. Clinical variables encompassed indication for LTx, time since LTx and current immunossupressive drugs. Self reported current and past smoking and alcohol consumption were also collected. The patients' weight (kilograms) on the first outpatient visit after LTx was collected from their medical recorders, it is regularly measured with patients wearing light street clothing, no shoes, on a calibrated mechanical scale (Filizola®). Current height (meters) and weight (kilograms) of patients were measured on the day of the interview. Considering these weights, weight gain was assessed by the difference between the current weight and the first post-LTx outpatient weight. Nutritional status was defined according to body mass index (BMI) values as underweight, BMI <18.5 kg/m²; normal weight, BMI 18.5-24.9 kg/m²; overweight, BMI 24.9-29.9 kg/m² and obese, BMI >30 kg/m².
40 minutes

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Federal University of Minas Gerais

Collaboratori

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 agosto 2016

Completamento primario (Effettivo)

23 febbraio 2017

Completamento dello studio (Effettivo)

23 febbraio 2017

Date di iscrizione allo studio

Primo inviato

6 gennaio 2018

Primo inviato che soddisfa i criteri di controllo qualità

19 gennaio 2018

Primo Inserito (Effettivo)

26 gennaio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 gennaio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 gennaio 2018

Ultimo verificato

1 gennaio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAAE - 10726313.3.0000.5149

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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