ObesityMERCNCT02455973
Interdisciplinary Intervention With Motivational Approach in Adolescents With Overweight and Obesity.
A study testing Lifestyle modification and cardiovascular risk and Health Education in people with Obesity and Overweight, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Lifestyle modification and cardiovascular risk and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between 15 and 18 years with BMI ≥ 85th percentile.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Interdisciplinary Intervention Effectiveness on Motivational Approach in Lifestyle Modification 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.
Read more
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.
Read the 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
- Being tested
- Lifestyle modification and cardiovascular risk, Health Education
- Keywords
- obesity, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modification and cardiovascular riskBehavioural
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 EducationBehavioural
The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk
| Study group | Role | What they receive |
|---|---|---|
| Transtheoretical model of change | Experimental | In this type of intervention, the focus will be the development of skills through educational activities on health based on interdisciplinary motivational strategies. Receives: Behavioral: Lifestyle modification and cardiovascular risk |
| Health information | Placebo comparator | In this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured after three months at the end of intervention
Secondary outcomes (10)
Abdominal circumference measured by waist circumference in cm
Reduction of at least 5% abdominal circumference measured by waist circumference in cm
Measured: Measured after three months at the end of intervention
Dietary aspects as measured by healthy eating index (IAS)
Improves 5% of the Diet quality measured by healthy eating index (IAS)
Measured: Measured after three months at the end of intervention
Capacity cardiopulmonary measured by VO2 max
Increase 5% in capacity cardiopulmonary measured by VO2 max
Measured: Measured after three months at the end of intervention
Blood pressure measured by the blood pressure measurement
Reduced at least 7% in systolic blood pressure measured by the blood pressure measurement
Measured: Measured after three months at the end of intervention
Plasma triglycerides measured by the blood sample
Reduction of at least 20% of the plasma triglycerides measured by the blood sample
Measured: Measured after three months at the end of intervention
Plasma HDL cholesterol measured by the blood sample
Increase of at least 5% of the plasma HDL cholesterol measured by the blood sample
Measured: Measured after three months at the end of intervention
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: Measured after three months at the end of intervention
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: Measured after three months at the end of intervention
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: Measured after three months at the end of intervention
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: Measured after three months at the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Sponsor
- Investigators
- Margareth da Silva Oliveira, PHD, Principal investigator, Pontifical Catholic University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455973
- Sponsor's protocol ID
- MERC
- Acronym
- MERC
- Status last verified
- Sep 2020
- First submitted
- 25 Apr 2015
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830.
PubMed 19739882Prochaska 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.
PubMed 1329589Velasquez 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.
Miller WR; Rollnick S. Motivational Interviewing, Second Edition: Preparing People for Change.New York, NY: The Guilford Press, 2002. 482 p.
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.
PubMed 32428066
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Intervention Effectiveness on Motivational Approach in Lifestyle Modification in Adolescents With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT02455973
- Acronym / sponsor ID
- MERC / MERC
- Conditions
- Obesity, Overweight
- Keywords
- obesity, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Mar 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtheoretical model of change | Experimental | Behavioral: Lifestyle modification and cardiovascular riskIn 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 comparator | Behavioral: Health EducationIn this type of intervention, the focus will be the development of skills through educational activities on health using the pedagogy of transmission. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents between 15 and 18 years with BMI ≥ 85th percentile.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modification and cardiovascular riskGroup 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. | Behavioural | Transtheoretical model of change |
| Health EducationThe meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk | Behavioural | Health information |
Primary outcome
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.
10 secondary outcomes
Abdominal circumference measured by waist circumference in cm
Time frame: Measured after three months at the end of intervention
Dietary aspects as measured by healthy eating index (IAS)
Time frame: Measured after three months at the end of intervention
Capacity cardiopulmonary measured by VO2 max
Time frame: Measured after three months at the end of intervention
Blood pressure measured by the blood pressure measurement
Time frame: Measured after three months at the end of intervention
Plasma triglycerides measured by the blood sample
Time frame: Measured after three months at the end of intervention
Plasma HDL cholesterol measured by the blood sample
Time frame: Measured after three months at the end of intervention
Total cholesterol and LDL measured by the blood sample
Time frame: Measured after three months at the end of intervention
Glycemic profile assessed by fasting glucose
Time frame: Measured after three months at the end of intervention
Readiness for change measured by the readiness ruler to physical exercise
Time frame: Measured after three months at the end of intervention
Readiness for change measured by the readiness ruler to physical nutrition
Time frame: Measured after three months at the end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 19739882Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 2009 Sep;64(6):527-37. doi: 10.1037/a0016830.
- Background: PubMed 1329589Prochaska 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.
- BackgroundVelasquez 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.
- Derived from this study: PubMed 32428066Zanatta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margareth da Silva Oliveira, PHD principal investigator
Pontifical Catholic University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification and cardiovascular risk and Health Education in people with Obesity and Overweight, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455973, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.