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

NCT ID: NCT02455973

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transtheoretical model of change

In this type of intervention, the focus will be the development of skills through educational activities on health based on interdisciplinary motivational strategies.

Group Type: EXPERIMENTAL

Lifestyle modification and cardiovascular risk

Intervention Type: 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 information

In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission.

Group Type: PLACEBO_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Health Education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role: collaborator

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margareth da Silva Oliveira, PHD

Role: PRINCIPAL_INVESTIGATOR

Pontifical Catholic University of Rio Grande do Sul

Locations

Pontifical Catholic University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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

Reference Type: BACKGROUND

PMID: 19739882 (View on PubMed)

Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.

Reference Type: BACKGROUND

PMID: 1329589 (View on PubMed)

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Zanatta LB, Heinzmann-Filho JP, Vendrusculo FM, Campos NE, Oliveira MDS, Feoli AMP, Gustavo ADS, Donadio MVF. Effect of an interdisciplinary intervention with motivational approach on exercise capacity in obese adolescents: a randomized controlled clinical trial. Einstein (Sao Paulo). 2020;18:eAO5268. doi: 10.31744/einstein_journal/2020ao5268. Epub 2020 May 18.

Reference Type: DERIVED

PMID: 32428066 (View on PubMed)

Other Identifiers

MERC

Identifier Type: -

Identifier Source: org_study_id