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Interdisciplinary Intervention With Motivational Approach in Adolescents With Overweight and Obesity. (MERC)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lifestyle modification and cardiovascular risk
Health Education
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontifical Catholic University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transtheoretical model of change

Health information

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Abdominal circumference measured by waist circumference in cm
Reduction of at least 5% abdominal circumference measured by waist circumference in cm
Dietary aspects as measured by healthy eating index (IAS)
Improves 5% of the Diet quality measured by healthy eating index (IAS)
Capacity cardiopulmonary measured by VO2 max
Increase 5% in capacity cardiopulmonary measured by VO2 max
Blood pressure measured by the blood pressure measurement
Reduced at least 7% in systolic blood pressure measured by the blood pressure measurement
Plasma triglycerides measured by the blood sample
Reduction of at least 20% of the plasma triglycerides measured by the blood sample
Plasma HDL cholesterol measured by the blood sample
Increase of at least 5% of the plasma HDL cholesterol measured by the blood sample
Total cholesterol and LDL measured by the blood sample
Reduction of at least 5% in total cholesterol and LDL measured by the blood sample
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
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
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

Full Information

First Posted
April 25, 2015
Last Updated
September 28, 2020
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02455973
Brief Title
Interdisciplinary Intervention With Motivational Approach in Adolescents With Overweight and Obesity.
Acronym
MERC
Official Title
Interdisciplinary Intervention Effectiveness on Motivational Approach in Lifestyle Modification in Adolescents With Overweight and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transtheoretical model of change
Arm Type
Experimental
Arm Description
In this type of intervention, the focus will be the development of skills through educational activities on health based on interdisciplinary motivational strategies.
Arm Title
Health information
Arm Type
Placebo Comparator
Arm Description
In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification and cardiovascular risk
Intervention Description
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
Intervention Name(s)
Health Education
Intervention Description
The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk
Primary Outcome Measure Information:
Title
Body mass index (BMI) measured by height and weight and taking the z score.
Description
Reduction of at least 0.5 percentile point in 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
Secondary Outcome Measure Information:
Title
Abdominal circumference measured by waist circumference in cm
Description
Reduction of at least 5% abdominal circumference measured by waist circumference in cm
Time Frame
Measured after three months at the end of intervention
Title
Dietary aspects as measured by healthy eating index (IAS)
Description
Improves 5% of the Diet quality measured by healthy eating index (IAS)
Time Frame
Measured after three months at the end of intervention
Title
Capacity cardiopulmonary measured by VO2 max
Description
Increase 5% in capacity cardiopulmonary measured by VO2 max
Time Frame
Measured after three months at the end of intervention
Title
Blood pressure measured by the blood pressure measurement
Description
Reduced at least 7% in systolic blood pressure measured by the blood pressure measurement
Time Frame
Measured after three months at the end of intervention
Title
Plasma triglycerides measured by the blood sample
Description
Reduction of at least 20% of the plasma triglycerides measured by the blood sample
Time Frame
Measured after three months at the end of intervention
Title
Plasma HDL cholesterol measured by the blood sample
Description
Increase of at least 5% of the plasma HDL cholesterol measured by the blood sample
Time Frame
Measured after three months at the end of intervention
Title
Total cholesterol and LDL measured by the blood sample
Description
Reduction of at least 5% in total cholesterol and LDL measured by the blood sample
Time Frame
Measured after three months at the end of intervention
Title
Glycemic profile assessed by fasting glucose
Description
Glycemic profile is expected to be reduced by at least 5% at the end of the intervention assessed by fasting glucose
Time Frame
Measured after three months at the end of intervention
Title
Readiness for change measured by the readiness ruler to physical exercise
Description
Increase of one point in the continuous variable readiness to change for performing physical exercise measured by the readiness ruler to physical exercise
Time Frame
Measured after three months at the end of intervention
Title
Readiness for change measured by the readiness ruler to physical nutrition
Description
Increase of one point in the continuous variable readiness to change for performing physical nutrition measured by the readiness ruler to physical exercise
Time Frame
Measured after three months at the end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareth da Silva Oliveira, PHD
Organizational Affiliation
Pontifical Catholic University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontifical Catholic University of Rio Grande do Sul
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19739882
Citation
Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830.
Results Reference
background
PubMed Identifier
1329589
Citation
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.
Results Reference
background
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.
Results Reference
background
Citation
Miller WR; Rollnick S. Motivational Interviewing, Second Edition: Preparing People for Change.New York, NY: The Guilford Press, 2002. 482 p.
Results Reference
background
PubMed Identifier
32428066
Citation
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.
Results Reference
derived

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

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