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Trial record 6 of 9 for:    11468499 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02745795
Recruitment Status : Unknown
Verified April 2016 by Maria do Céu Machad, Centro Hospitalar Lisboa Norte.
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Sponsor:
Collaborators:
Faculdade de Medicina de Lisboa
Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto
Information provided by (Responsible Party):
Maria do Céu Machad, Centro Hospitalar Lisboa Norte

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Motivational Interview Behavioral: Conventional Interview Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Self-concept score [ Time Frame: Six months ]
    Self-report score assessed by a paper questionnaire (Self Perception Profile for Children)

  2. Quality of life score [ Time Frame: Six months ]
    Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)

  3. Depressive symptoms score [ Time Frame: Six months ]
    Depressive symptoms score assessed by Children Depression Inventory (CDI)

  4. Anxiety symptoms [ Time Frame: Six months ]
    Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2)

  5. Abdominal circumference in centimeters [ Time Frame: Six months ]
    Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany)

  6. Blood pressure in mm Hg [ Time Frame: Six months ]
    Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany)

  7. Weight in kilograms [ Time Frame: Six months ]
    Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan)

  8. Height in meters [ Time Frame: Six months ]
    Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany)



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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745795


Sponsors and Collaborators
Centro Hospitalar Lisboa Norte
Faculdade de Medicina de Lisboa
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02745795     History of Changes
Other Study ID Numbers: CC-336
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maria do Céu Machad, Centro Hospitalar Lisboa Norte:
Motivational interview
adolescents
obesity
overweight
physical activity
diet

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms