NCT02455973

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

April 25, 2015

Last Update Submit

September 28, 2020

Conditions

Keywords

obesityoverweight

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

EXPERIMENTAL

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

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.

Behavioral: Health Education

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.

Transtheoretical model of change

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

Health information

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

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: 19739882BACKGROUND
  • 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.

    PMID: 1329589BACKGROUND
  • 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.

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

    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.

MeSH Terms

Conditions

ObesityOverweight

Interventions

Heart Disease Risk Factors

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk FactorsRiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Margareth da Silva Oliveira, PHD

    Pontifical Catholic University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

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

Locations