Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents
NCT ID: NCT02745795
Last Updated: 2016-04-20
Study Results
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Basic Information
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UNKNOWN
NA
83 participants
INTERVENTIONAL
2015-10-31
2016-05-31
Brief Summary
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Detailed Description
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The present study's main objective is to investigate the efficacy of a MI intervention in adolescents with weight excess, in a school setting, over their motivation to adhere to a health lifestyle plan of dietary habits and physical exercise.
Secondary objectives are to investigate the effect of MI over self-concept, quality of life, depressive symptoms, anxiety symptoms, body mass index, abdominal circumference and blood pressure.
Registry Procedures Data on anthropometric parameters is recorded in data collection sheet and stored in individual files, which are available for monitoring procedures and for auditing by the Metabolic and Food Behavior Disorders Scientific Committee.
Data Checks Data checks will be performed to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source Data Verification All the data will be checked to assess accuracy, completeness, or representativeness of registry data by comparing the data to external data sources: audio-taped interviews, paper case report forms and paper case self-report forms. All the registries will be stored during five years after study completions according to the Medical Faculty of Lisbon norms.
Variables:
Motivational Interview Audio-taped clinical interview record Motivational Interviewing Treatment Integrity (MITI) version 3.1.1
Motivation to adhere to a physical exercise plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet
Motivation to adhere to a diet plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise
Self-concept Self-report by a paper questionnaire Self Perception Profile for Children
Quality of life Self-report by a paper questionnaire Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)
Depressive symptoms Self-report by a paper questionnaire Children Depression Inventory (CDI)
Anxiety symptoms Self-report by a paper questionnaire State-Trait Anxiety Inventory for Children (STAIC C-2)
Body mass index Calculated by the ratio of weight in kilograms over the square of height in meters\^2.
Weight Direct measurement by the research team Measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan) in kilograms
Height Direct measurement by the research team Measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany) in meters
Abdominal circumference Direct measurement by the research team Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany) in centimeters
Blood pressure Direct measurement by the research team Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany) in mm Hg
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MIG: Motivational Interview Group
Group submitted to three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Motivational Interview
Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
CIG: Conventional Intervention Group
Group submitted to three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Conventional Interview
Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Interventions
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Motivational Interview
Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Conventional Interview
Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Eligibility Criteria
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Inclusion Criteria
* Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010)
Exclusion Criteria
* pregnancy
* breastfeeding
* endocrine disease
* present therapy with antidepressant or hypoglycemic drugs
* present treatment for food behavior disease or depression
* cognitive impairment of the student or his/her legal tutor.
14 Years
19 Years
ALL
Yes
Sponsors
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University of Lisbon
OTHER
Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto
UNKNOWN
Centro Hospitalar Lisboa Norte
OTHER
Responsible Party
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Maria do Céu Machad
Director of the Department of Pediatry of Centro Hospitalar Lisboa Norte, Chair of Pediatry at Medicine School of the University of Lisbon
Principal Investigators
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Marina Serra-de-Lemos, PhD
Role: STUDY_CHAIR
Faculty of Psychology and Education Sciences of University of Porto
References
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Other Identifiers
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CC-336
Identifier Type: -
Identifier Source: org_study_id
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