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Clinical Trials/NCT02745795
NCT02745795
Unknown
Not Applicable

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

Centro Hospitalar Lisboa Norte0 sites83 target enrollmentOctober 2015
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Centro Hospitalar Lisboa Norte
Enrollment
83
Primary Endpoint
Motivation scores to adhere to a diet and physical activity plan
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
May 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centro Hospitalar Lisboa Norte
Responsible Party
Principal Investigator
Principal Investigator

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

Centro Hospitalar Lisboa Norte

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Anxiety symptoms(Six months)
  • Blood pressure in mm Hg(Six months)
  • Height in meters(Six months)
  • Weight in kilograms(Six months)
  • Self-concept score(Six months)
  • Quality of life score(Six months)
  • Depressive symptoms score(Six months)
  • Abdominal circumference in centimeters(Six months)

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