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

April 17, 2016 updated by: Maria do Céu Machad, Centro Hospitalar Lisboa Norte

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
SHAM_COMPARATOR: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Lisboa Norte

Collaborators

University of Lisbon
Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto

Investigators

  • Study Chair: Marina Serra-de-Lemos, PhD, Faculty of Psychology and Education Sciences of University of Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 17, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 17, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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