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Completed

NCT Number: NCT04193384

Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.

The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil

About this study

Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1> (G1>) - patients that performed bariatric surgery for > 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by [TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bariatric patients without regular medical follow-up

Exclusion criteria

  • Pregnancy
  • Bariatric patients under one year of surgery

Treatment and study plan

Primary outcomes

  1. Analysis of the association between weight regain and alcohol abuse disorder

    Time frame: through study completion, an average of 1 year

    Analysis of the association between weight regain (weight in kg) and Alcohol abuse (avaliated by Alcohol Use Disorders Identification Test) in the first clinical evaluation

  2. Analysis of the association between weight regain and general psychopathology

    Time frame: through study completion, an average of 1 year

    Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation

  3. Analysis of the association between weight regain and physical activity level

    Time frame: through study completion, an average of 1 year

    Analysis of the association between weight regain (weight in kg) and physical activity (avaliated by International Physical Activity Questionnaire and the ActiGraph accelerometer) in the first clinical evaluation

  4. Analysis of the association between weight regain and quality of life indicators

    Time frame: through study completion, an average of 1 year

    Analysis of the association between weight regain (weight in kg) and quality of life (avaliated by the 36-Item Short-Form Health Survey Questionnaire) in the first clinical evaluation

  5. Analysis of the association between weight regain and eating Disorder

    Time frame: through study completion, an average of 1 year

    Analysis of the association between weight regain (weight in kg) and eating disorder (avaliated by Eating Disorder Examination-Questionnaire and Repetitive eating questionnaire) in the first clinical evaluation

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.

Acronym: Obesity

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 10, 2019
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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