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Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents (IMAGINE)

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interview
Conventional Interview
Sponsored by
Centro Hospitalar Lisboa Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Motivational interview, adolescents, obesity, overweight, physical activity, diet

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    MIG: Motivational Interview Group

    CIG: Conventional Intervention Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 5, 2016
    Last Updated
    April 17, 2016
    Sponsor
    Centro Hospitalar Lisboa Norte
    Collaborators
    University of Lisbon, Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02745795
    Brief Title
    Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents
    Acronym
    IMAGINE
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Hospitalar Lisboa Norte
    Collaborators
    University of Lisbon, Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Motivational interview, adolescents, obesity, overweight, physical activity, diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MIG: Motivational Interview Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CIG: Conventional Intervention Group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interview
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conventional Interview
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Motivation scores to adhere to a diet and physical activity plan
    Description
    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)
    Time Frame
    Six months
    Secondary Outcome Measure Information:
    Title
    Self-concept score
    Description
    Self-report score assessed by a paper questionnaire (Self Perception Profile for Children)
    Time Frame
    Six months
    Title
    Quality of life score
    Description
    Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)
    Time Frame
    Six months
    Title
    Depressive symptoms score
    Description
    Depressive symptoms score assessed by Children Depression Inventory (CDI)
    Time Frame
    Six months
    Title
    Anxiety symptoms
    Description
    Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2)
    Time Frame
    Six months
    Title
    Abdominal circumference in centimeters
    Description
    Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany)
    Time Frame
    Six months
    Title
    Blood pressure in mm Hg
    Description
    Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany)
    Time Frame
    Six months
    Title
    Weight in kilograms
    Description
    Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan)
    Time Frame
    Six months
    Title
    Height in meters
    Description
    Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany)
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marina Serra-de-Lemos, PhD
    Organizational Affiliation
    Faculty of Psychology and Education Sciences of University of Porto
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents

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