Obesity Clinical Trial
— MERCOfficial title:
Interdisciplinary Intervention Effectiveness on Motivational Approach in Lifestyle Modification in Adolescents With Overweight and Obesity
| 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 |
| 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 |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Pontifical Catholic University of Rio Grande do Sul | Porto Alegre | RS |
| 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 |
Brazil,
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.
| 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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