Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents

Study Overview
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Brief Summary
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The objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight.

Detailed Description
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Motivational interview (MI) is a style of communication collaborative, objective-directed, with special attention to change talk. 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

Official Title
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Motivational Intervention Through the Generation of an Interpersonal Plan About Nutrition and Physical Exercise Study (IMAGINE Study), a Randomized Controlled Trial With Obese and Overweight Adolescents in Portuguese High Schools

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Motivational Interview
* Behavioral: Conventional Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 14 and 19 years old Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010) Exclusion Criteria (one or more of the following): recent weight loss of 10% or more of body weight 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIG: Motivational Interview Group<br>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. | Behavioral: Motivational Interview<br>* 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.<br>|
| Sham Comparator: CIG: Conventional Intervention Group<br>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. | Behavioral: Conventional Interview<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation scores to adhere to a diet and physical activity plan | Motivation scores assessed by two self-report confidential paper questionnaires (Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet and Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-concept score | Self-report score assessed by a paper questionnaire (Self Perception Profile for Children) | Six months | 
| Quality of life score | Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0) | Six months | 
| Depressive symptoms score | Depressive symptoms score assessed by Children Depression Inventory (CDI) | Six months | 
| Anxiety symptoms | Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2) | Six months | 
| Abdominal circumference in centimeters | Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany) | Six months | 
| Blood pressure in mm Hg | Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany) | Six months | 
| Weight in kilograms | Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan) | Six months | 
| Height in meters | Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany) | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational interview, adolescents, obesity, overweight, physical activity, diet