Interdisciplinary Intervention With Motivational Approach in Adolescents With Overweight and Obesity.
MERC
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Mar 2015
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 30, 2020
September 1, 2020
2.5 years
April 25, 2015
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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)
Measured after three months at the end of intervention
Capacity cardiopulmonary measured by VO2 max
Measured after three months at the end of intervention
Blood pressure measured by the blood pressure measurement
Measured after three months at the end of intervention
Plasma triglycerides measured by the blood sample
Measured after three months at the end of intervention
- +5 more secondary outcomes
Study Arms (2)
Transtheoretical model of change
EXPERIMENTALIn this type of intervention, the focus will be the development of skills through educational activities on health based on interdisciplinary motivational strategies.
Health information
PLACEBO COMPARATORIn this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission.
Interventions
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.
The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk
Eligibility Criteria
You may qualify if:
- Adolescents between 15 and 18 years with BMI ≥ 85th percentile.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (5)
Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830.
PMID: 19739882BACKGROUNDProchaska 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.
PMID: 1329589BACKGROUNDVelasquez 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.
BACKGROUNDMiller WR; Rollnick S. Motivational Interviewing, Second Edition: Preparing People for Change.New York, NY: The Guilford Press, 2002. 482 p.
BACKGROUNDZanatta 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.
PMID: 32428066DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margareth da Silva Oliveira, PHD
Pontifical Catholic University of Rio Grande do Sul
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2015
First Posted
May 28, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
September 30, 2020
Record last verified: 2020-09