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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02745795
• Other study ID #: CC-336
• Status: Active, not recruiting
• Phase: N/A
• First received: April 5, 2016
• Last updated: April 17, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2016
• Source: Centro Hospitalar Lisboa Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Data Protection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Norte	Faculdade de Medicina de Lisboa, Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto

References & Publications (29)

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Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008. — View Citation

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Resnicow K, Davis R, Rollnick S. Motivational interviewing for pediatric obesity: Conceptual issues and evidence review. J Am Diet Assoc. 2006 Dec;106(12):2024-33. Review. — View Citation

Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-concept score	Self-report score assessed by a paper questionnaire (Self Perception Profile for Children)	Six months	No
Secondary	Quality of life score	Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)	Six months	No
Secondary	Depressive symptoms score	Depressive symptoms score assessed by Children Depression Inventory (CDI)	Six months	No
Secondary	Anxiety symptoms	Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2)	Six months	No
Secondary	Abdominal circumference in centimeters	Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany)	Six months	No
Secondary	Blood pressure in mm Hg	Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany)	Six months	No
Secondary	Weight in kilograms	Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan)	Six months	No
Secondary	Height in meters	Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany)	Six months	No