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Eating BehaviorNCT03411616

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

An observational study of Eating Behavior and Liver Transplant, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eating Behavior, Liver Transplant
How many people
301 participants
Where
1 siteBrazil
Study dates
23 Aug 2016to 23 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital of Clinics of the University Federal of Minas Gerais

    Belo Horizonte, Minas Gerais

Other trials in Brazil

About this study

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.

Keywords
Eating behavior, Excessive weight, Food craving, Liver transplantation, Obesity, Weight gain
Medical subject headings
Feeding Behavior, Obesity, Weight Gain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating behavior

    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.

    Measured: 40 minutes

Secondary outcomes (3)

  1. Food Craving Questionnaires State (FCQ-S)

    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.

    Measured: 20 minutes

  2. Food Craving Questionnaires Trait (FCQ-T)

    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.

    Measured: 20 minutes

  3. Brazilian Inventory of Foods Related to Craving (FCI-Br)

    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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start23 Aug 2016
  3. Primary completion23 Feb 2017
  4. Study completion23 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03411616
Sponsor's protocol ID
CAAE - 10726313.3.0000.5149
Status last verified
Jan 2018
First submitted
6 Jan 2018
Last updated
26 Jan 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Behavior and Liver Transplant, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating behavior (time frame: 40 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.

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