Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/10/2014
Date assigned
07/11/2014
Last edited
07/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obesity is a major public health concern. There are worrying trends in Europe, with evidence suggesting that levels are rising and that the rise is consistent across most European countries. In Portugal there is evidence for accelerating rates of overweight and obesity in children. Obesity is related to several heart-related disease risk factors and metabolic problems, even in childhood, and it is therefore likely to be a major contributor to other diseases and death from heart disease in later years. Less quantifiable - but equally important - costs can be attributed to psychological stress, social problems and bullying. The cause of obesity is likely to be rooted in the genetic make-up, critical environmental influences, and energy balance behaviours: physical activity (PA) and diet. A range of additional psychosocial and demographic influences can modify these relationships. We have very limited information that address these subtle and complex relationships. Schools are a good place for implementation of interventions, as they have continuous, intensive contact with children during their formative years. School infrastructure and physical environment, policies, curricula, and personnel have great potential to positively influence child health. Despite the apparent advantages of addressing obesity in schools, evidence of effectiveness has led some to question the wisdom of allocating scarce resources to school-based programs. The main aim of this study is to develop, implement and evaluate a culturally appropriate school-based intervention that promotes healthy eating behaviours and increased PA to prevent obesity.

Who can participate?
Boys and girls who can engage in physical activity enrolled in the 5, 6, and 7th grades, attending the participating schools.

What does the study involve?
Participants were randomly allocated to one of three groups. The first (control) group will be given general information regarding eating and PA behaviours; the second group, besides the standard counselling, will be provided with two additional hours of formal PA and an educational program; the third group, in addition to the standard counselling and the two additional hours of formal PA, will be provided with a parents health and weight educational program, implementing principles and basic knowledge within the components of PA, eating behaviour and well-being designed to influence the healthy choices of the entire family. We will assess sedentary behaviour, physical activity, cardiorespiratory fitness and body composition. We also will look at three sets of perceived personal, social, and physical and social environmental factors that hold great promise for understanding and predicting PA behaviour.

What are the possible benefits and risks of participating?
Participants have 30 classroom sessions addressing healthy lifestyles through increased PA and healthy diet. Participants are provided with all assessments and related counselling information based upon the results. Considering that all assessments are performed by trained personal, no risks are associated.

Where is the study run from?
The study is run in the public schools of the Oeiras Municipality, with some of the assessment made in the Exercise and Health Laboratory, Faculty of Human Kinetics, University of Lisbon, Portugal.

When is the study starting and how long is it expected to run for?
September 2010 to September 2013.

Who is funding the study?
Portuguese Foundation for Science and Technology (Portugal).
Who is the main contact?
Prof Luis Sardinha
lsardinha@fmh.ulisboa.pt

Trial website

Contact information

Type

Scientific

Primary contact

Prof Luis Sardinha

ORCID ID

Contact details

Estrada da Costa
Cruz-Quebrada Dafundo
1499-002
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PTDC/DES/108372/2008

Study information

Scientific title

A Physical activity and family-based intervention in pediatric obesity prevention in the school setting: a randomised controlled trial

Acronym

PESSOA

Study hypothesis

1. Standard counseling and two additional hours of formal physical activity, together with a parents health and weight educational program, will induce significant impact on sedentary behavior, physical activity and body composition, as compared with a control group with standard protocol with general information regarding eating and physical activity behaviors.
2. Standard counseling and two additional hours of formal physical activity, together with a parents health and weight educational program, will induce significant impact on sedentary behavior, physical activity and body composition, as compared with a standard counseling providing two additional hours of formal physical activity and an educational program.

Ethics approval

Scientific committee of the Faculty of Human Kinetics of the University of Lisbon

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Physical activity, cardiorespiratory fitness and body composition

Intervention

The study used a group-randomized design in which schools were the unit of randomization and students were the unit of analysis. Schools were randomly allocated to one of two different groups:
1. The first (control) group was intervened with a standard protocol with general information regarding eating and PA behaviors
2. The second group (intervention), besides the standard counseling, was provided a 90-min additional weekly sessions with health and weight educational program and PA activities.
Besides regular physical education classes based on the Portuguese national curriculum (usually one weekly session of 90 min and another of 45 min), students in the intervention group also received a standardized set of extra opportunities for further PA. On these educational sessions, basic knowledge about PA, eating behavior and well-being were taught using an experiential learning methodology in an autonomy supportive style, where the importance of the behavior is valued and can be experienced in consonance with other important life values and goals and, at the same time, be interesting and enjoyable. The classroom lessons deal with healthy nutrition, active living, and healthy lifestyle choices and are provided by the regular classroom teacher, who receives an extensive manual on the lessons. The central theme of the lessons is to enjoy a fit and healthy lifestyle.
Specific topics start with a homework assignment to be completed with the help of parents. Assessment and awareness of the child’s behavior are the central themes of the home assignment. Each classroom lesson consists of theoretical and practical parts, during which knowledge is transferred and subsequently applied through activities like games, puzzles and tests. Each lesson finishes with goal setting by drawing up a joint agreement regarding lifestyle for the period until the next lesson. Educational material and classroom posters for writing down the agreements are part of the provided material.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sedentary behavior measured objectively with accelerometers and a validated Portuguese version of the Physical Activity Questionnaire (PAQ)
2. Physical activity measured objectively with accelerometers and a validated Portuguese version of the Physical Activity Questionnaire (PAQ)
3. Cardiorespiratory fitness is assessed by the 20-meter multi-stage shuttle run test and by a multi-stage maximal bicycle ergometer test
4. Body composition is assessed by dual-energy X-ray absorptiometry (DXA) and by standard anthropometric procedures

All primary outcomes are assessed at baseline and at the end of the intervention.

Secondary outcome measures

1. Academic achievement
2. Health-related quality of life
3. Perceived personal, social, and physical and social environmental factors

The following questionnaires were also used: the validated Portuguese version of the Kidscreen-10, to measure QoL; the validated Portuguese version of the BREQ-2, for the Behavioral Regulations for Exercise; and, a selection of the parental support, parental encouragement, peer support and teacher support-related items present in the questionnaire used in the Personal and Environmental Associations with Children’s Health (PEACH) study, to assess perceived social support. Academic performance is assessed using the marks students had, at the end of their academic year, in mathematics, language (Portuguese), foreign language (English), and sciences. All secondary outcomes are assessed at baseline and at the end of the intervention.

Overall trial start date

01/09/2010

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Boys and girls without contraindications for physical activity enrolled in the 5, 6, and 7th grades, attending 14 high schools in the Oeiras Municipality.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2543

Participant exclusion criteria

Limitations for physical activity practice in Physical Education classes.

Recruitment start date

01/09/2010

Recruitment end date

01/09/2013

Locations

Countries of recruitment

Portugal

Trial participating centre

Estrada da Costa
Cruz-Quebrada Dafundo
1499-002
Portugal

Sponsor information

Organisation

Portuguese Foundation for Science and Technology (Portugal)

Sponsor details

Av. D. Carlos I
126
Lisboa
1249-074
Portugal

Sponsor type

Research organisation

Website

http://www.fct.pt/index.phtml.pt

Funders

Funder type

Research organisation

Funder name

Portuguese Foundation for Science and Technology (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes