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

January 19, 2018 updated by: 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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating behavior
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Craving Questionnaires State (FCQ-S)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic, lifestyle, clinical and anthropometric variables
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2016

Primary Completion (Actual)

February 23, 2017

Study Completion (Actual)

February 23, 2017

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE - 10726313.3.0000.5149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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