Eating Behavior, Food Craving and Relation to Excessive Weight Gain in Patients Submitted to Liver Transplantation
2018年1月19日 更新者：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.
研究概览
研究类型
观察性的
注册 (实际的)
301
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西
- Hospital of Clinics of the University Federal of Minas Gerais
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients who undergone liver transplantation at least 18 years of age, who were regularly followed up at the Bias Fortes outpatient clinic
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：横截面
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Eating behavior
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Food Craving Questionnaires State (FCQ-S)
大体时间：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)
大体时间：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)
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Demographic, lifestyle, clinical and anthropometric variables
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年8月23日
初级完成 (实际的)
2017年2月23日
研究完成 (实际的)
2017年2月23日
研究注册日期
首次提交
2018年1月6日
首先提交符合 QC 标准的
2018年1月19日
首次发布 (实际的)
2018年1月26日
研究记录更新
最后更新发布 (实际的)
2018年1月26日
上次提交的符合 QC 标准的更新
2018年1月19日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.