Interdisciplinary Intervention With Motivational Approach in Adolescents With Overweight and Obesity.

Study Overview
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Brief Summary
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This study is a randomized clinical trial with two interventions: control group and intervention interdisciplinary group, without cross-over. Control Group (CG): In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission. Interdisciplinary Intervention Group (IG): In this type of intervention, the focus will be the development of skills through educational activities on health that provide the development of autonomy and empowerment for behavior change, based on interdisciplinary motivational strategies. All topics will be focused on the major cardiovascular risk factors considered modifiable. The staff is trained to the techniques of motivational interviewing and transtheoretical model of change and the health issues related to the modification of lifestyle. So this interdisciplinary intervention with adolescents seeks to measure the result of an educational proposal using the techniques of motivational interviewing and transtheoretical model of change, for all professionals involved independent training in health issues related approach to lifestyle modification and the inclusion of family in this process.

Detailed Description
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This study is a randomized clinical trial with two interventions: control group and intervention interdisciplinary group, without cross-over. Interventions will take place at the Rehabilitation Hospital São Lucas Center (CR), will have 12 sessions for each of the following ways: Control Group (CG): In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission. The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk factors and prevention.The sample is 60 adolescents with overweight or obesity. Interdisciplinary Intervention Group (IG): In this type of intervention, the focus will be the development of skills through educational activities on health that provide the development of autonomy and empowerment for behavior change, based on interdisciplinary motivational strategies. Therefore, group meetings will be performed in the presence of a member of the nursing staff, physiotherapy, nutrition and psychology. The meetings are weekly, lasting 1 hour and 45 minutes. In the first 1 hour and 15 minutes will be addressed health issues related to lifestyle modification (self-care, healthy eating and physical activity) using the fundamentals of motivational interviewing technique. All topics will be focused on the major cardiovascular risk factors considered modifiable. The staff is trained to the techniques of motivational interviewing and transtheoretical model of change and the health issues related to the modification of lifestyle. During the sessions the team members address the health issue so that the knowledge of a professional complements the other. At the same time occur the integration of knowledge between these professionals from different areas aiming to encourage teens to lifestyle modification based on the techniques of motivational interviewing and transtheoretical model of change. Likewise, it is envisaged to include a time of physical activity (30 minutes) oriented in conjunction with the research team. This activity aims to motivate adolescents to include other physical activity sessions during the week. So this interdisciplinary intervention with adolescents seeks to measure the result of an educational proposal using the techniques of motivational interviewing and transtheoretical model of change, for all professionals involved independent training in health issues related approach to lifestyle modification and the inclusion of family in this process. Run in: There will be a meeting with the parents of the IG and CG (separately) in order to inform them about the participation of children in the program and guide them about the procedures of the research protocol.

Official Title
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Interdisciplinary Intervention Effectiveness on Motivational Approach in Lifestyle Modification in Adolescents With Overweight and Obesity

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Lifestyle modification and cardiovascular risk
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents between 15 and 18 years with BMI ≥ 85th percentile. Exclusion Criteria: Provide absolute contraindication for physical activity for musculoskeletal, neurological, vascular problems (intermittent claudication), lung and heart; presence of diagnosis of severe psychiatric disorders and / or presence of significant cognitive impairments;pregnant women; diagnosis of Diabetes mellitus type I.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transtheoretical model of change<br>In this type of intervention, the focus will be the development of skills through educational activities on health based on interdisciplinary motivational strategies. | Behavioral: Lifestyle modification and cardiovascular risk<br>* Group meetings will be performed in the presence of a member of the nursing staff, physiotherapy, nutrition and psychology. The meetings are weekly, lasting 1 hour and 45 minutes. In the first 1 hour and 15 minutes will be addressed health issues related to lifestyle modification (self-care, healthy eating and physical activity) using the fundamentals of motivational interviewing technique. All topics will be focused on the major cardiovascular risk factors considered modifiable.Likewise, it is envisaged to include a time of physical activity (30 minutes) oriented in conjunction with the research team. Run in: There will be a meeting with the parents in order to inform them about the participation of children in the program and guide them about the procedures of the research protocol.<br>|
| Placebo Comparator: Health information<br>In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission. | Behavioral: Health Education<br>* The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) measured by height and weight and taking the z score. | Reduction of at least 0.5 percentile point in body mass index (BMI) measured by height and weight and taking the z score. | Measured after three months at the end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal circumference measured by waist circumference in cm | Reduction of at least 5% abdominal circumference measured by waist circumference in cm | Measured after three months at the end of intervention | 
| Dietary aspects as measured by healthy eating index (IAS) | Improves 5% of the Diet quality measured by healthy eating index (IAS) | Measured after three months at the end of intervention | 
| Capacity cardiopulmonary measured by VO2 max | Increase 5% in capacity cardiopulmonary measured by VO2 max | Measured after three months at the end of intervention | 
| Blood pressure measured by the blood pressure measurement | Reduced at least 7% in systolic blood pressure measured by the blood pressure measurement | Measured after three months at the end of intervention | 
| Plasma triglycerides measured by the blood sample | Reduction of at least 20% of the plasma triglycerides measured by the blood sample | Measured after three months at the end of intervention | 
| Plasma HDL cholesterol measured by the blood sample | Increase of at least 5% of the plasma HDL cholesterol measured by the blood sample | Measured after three months at the end of intervention | 
| Total cholesterol and LDL measured by the blood sample | Reduction of at least 5% in total cholesterol and LDL measured by the blood sample | Measured after three months at the end of intervention | 
| Glycemic profile assessed by fasting glucose | Glycemic profile is expected to be reduced by at least 5% at the end of the intervention assessed by fasting glucose | Measured after three months at the end of intervention | 
| Readiness for change measured by the readiness ruler to physical exercise | Increase of one point in the continuous variable readiness to change for performing physical exercise measured by the readiness ruler to physical exercise | Measured after three months at the end of intervention | 
| Readiness for change measured by the readiness ruler to physical nutrition | Increase of one point in the continuous variable readiness to change for performing physical nutrition measured by the readiness ruler to physical exercise | Measured after three months at the end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight