Eating Behavior, Food Craving and Relation to Excessive Weight Gain in Patients Submitted to Liver Transplantation
19 janvier 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
301
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brésil
- Hospital of Clinics of the University Federal of Minas Gerais
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
N/A
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients who undergone liver transplantation at least 18 years of age, who were regularly followed up at the Bias Fortes outpatient clinic
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Autre
- Perspectives temporelles: Transversale
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Eating behavior
Délai: 40 minutes
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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.
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40 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Food Craving Questionnaires State (FCQ-S)
Délai: 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.
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20 minutes
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Food Craving Questionnaires Trait (FCQ-T)
Délai: 20 minutes
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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.
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20 minutes
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Brazilian Inventory of Foods Related to Craving (FCI-Br)
Délai: 20 minutes
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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.
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20 minutes
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Demographic, lifestyle, clinical and anthropometric variables
Délai: 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.
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40 minutes
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 août 2016
Achèvement primaire (Réel)
23 février 2017
Achèvement de l'étude (Réel)
23 février 2017
Dates d'inscription aux études
Première soumission
6 janvier 2018
Première soumission répondant aux critères de contrôle qualité
19 janvier 2018
Première publication (Réel)
26 janvier 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 janvier 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAAE - 10726313.3.0000.5149
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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