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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455973
Other study ID # MERC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 2017

Study information

Verified date September 2020
Source Pontificia Universidade Católica do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lifestyle modification and cardiovascular risk
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
The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk

Locations

Country Name City State
Brazil Pontifical Catholic University of Rio Grande do Sul Porto Alegre RS

Sponsors (3)

Lead Sponsor Collaborator
Pontificia Universidade Católica do Rio Grande do Sul Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830. Review. — View Citation

Miller WR; Rollnick S. Motivational Interviewing, Second Edition: Preparing People for Change.New York, NY: The Guilford Press, 2002. 482 p.

Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. — View Citation

Velasquez M; Maurer GG; Crouch C; DiClemente CC. Group treatment for substance abuse: a stages-of- change therapy manual. New York: The Guilford Press, 2001. 222 p.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Capacity cardiopulmonary measured by VO2 max Increase 5% in capacity cardiopulmonary measured by VO2 max Measured after three months at the end of intervention
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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