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Completed

NCT Number: NCT02455973

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontifical Catholic University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle modification and cardiovascular risk

Behavioral

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.

Health Education

Behavioral

The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk

Primary outcomes

  1. Body mass index (BMI) measured by height and weight and taking the z score.

    Time frame: Measured after three months at the end of intervention

    Reduction of at least 0.5 percentile point in body mass index (BMI) measured by height and weight and taking the z score.

Secondary outcomes

  1. Abdominal circumference measured by waist circumference in cm

    Time frame: Measured after three months at the end of intervention

    Reduction of at least 5% abdominal circumference measured by waist circumference in cm

  2. Dietary aspects as measured by healthy eating index (IAS)

    Time frame: Measured after three months at the end of intervention

    Improves 5% of the Diet quality measured by healthy eating index (IAS)

  3. Capacity cardiopulmonary measured by VO2 max

    Time frame: Measured after three months at the end of intervention

    Increase 5% in capacity cardiopulmonary measured by VO2 max

  4. Blood pressure measured by the blood pressure measurement

    Time frame: Measured after three months at the end of intervention

    Reduced at least 7% in systolic blood pressure measured by the blood pressure measurement

  5. Plasma triglycerides measured by the blood sample

    Time frame: Measured after three months at the end of intervention

    Reduction of at least 20% of the plasma triglycerides measured by the blood sample

  6. Plasma HDL cholesterol measured by the blood sample

    Time frame: Measured after three months at the end of intervention

    Increase of at least 5% of the plasma HDL cholesterol measured by the blood sample

  7. Total cholesterol and LDL measured by the blood sample

    Time frame: Measured after three months at the end of intervention

    Reduction of at least 5% in total cholesterol and LDL measured by the blood sample

  8. Glycemic profile assessed by fasting glucose

    Time frame: Measured after three months at the end of intervention

    Glycemic profile is expected to be reduced by at least 5% at the end of the intervention assessed by fasting glucose

  9. Readiness for change measured by the readiness ruler to physical exercise

    Time frame: Measured after three months at the end of intervention

    Increase of one point in the continuous variable readiness to change for performing physical exercise measured by the readiness ruler to physical exercise

  10. Readiness for change measured by the readiness ruler to physical nutrition

    Time frame: Measured after three months at the end of intervention

    Increase of one point in the continuous variable readiness to change for performing physical nutrition measured by the readiness ruler to physical exercise

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Registry information

Official study title

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

Acronym: MERC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 28, 2015
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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