ClinicalTrials.gg
Status unknownNCT03269513Updated Aug 31, 2017

OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017

An interventional study of Physical Exercise in Obesity, Overweight and Adolescent Obesity, sponsored by University of Santa Cruz do Sul. Status unknown at 1 site in Brazil. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-08-31.

Primary conditionPediatric ObesityRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pediatric Obesity
Why
  1. The study's listed conditions name Pediatric Obesity, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Santa Cruz do Sul · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

The study aims to evaluate the possible effects of an exercise program, nutritional and psychological, postural orientation and guidance of oral health on body composition, physical activity levels and lifestyle, physical fitness and health and motor performance, the factors risk of cardiovascular disease, eating habits, the cognition levels, the psychological profile, the body posture of children and adolescent with overweight and obesity, considering the presence of risk genotype associated with the development of obesity. In addition, identify the effects of orientation for oral health on the quality of life and healthy oral habits.

02

Conditions studied

  • Obesity
  • Overweight
  • Adolescent Obesity
  • Exercise

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03

In context

Pediatric Obesity Reclassified

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

University of Santa Cruz do Sul is the lead sponsor of 5 studies on the registry; none are open to participants now.

Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The official signing the and informed;
  • The student with 12 years or older must sign the consent term;
  • Age range: 10 to 17;
  • Gender: male and female;
  • No for blood collection;
  • No distinction in relation to social class, ethnicity or color;
  • To have a greater than 85th percentile;
  • Do not be participating in any other exercise program and dietary intervention;
  • Participate in the clarification meetings on the project, when the head of the student is committed to the project, the following: a) assume responsibility for bringing to the UNISC (building 42) and refer to their home, the participant student of this study, both in the days of assessment (testing and completion of the data collection instruments), as in the days of intervention: 2nd, 4th and 6th fairs, from 14h to 16h, including 15 minutes in advance to the host, call and guidance students;
  • Participate in intervention sessions during the period of 2 hours daily, the established days, following the guidelines given by the coordination of the project and the professionals of Physical Education, Nutrition, Psychology, Pharmacy, Physiotherapy, Medicine, Nursing and / or another area of health / education that can contribute to achieving the objectives of the intervention project;
  • Participate in the assessments and reassessments as protocols established by the project.

Exclusion criteria

Exclusion Criteria:

  • Students who submit a frequency less than 70% stake in the intervention;
  • Students who present to the practice of physical activity during the program implementation period;
  • Students who choose not to continue with the treatment of intervention proposed by the program;
  • Be in possession of any kind of illness, abnormality or health problem such as:

    • Hypertension untreated, Kidney diseases, Cardiac disorders, chronic renal failure, genetic diseases that have congenital malformations and mental retardation as Turner syndrome, Klinefelter syndrome and Down syndrome or cognitive impairment. And do not be carrying transmitted diseases vertically (from mother to child) with anatomical deformations caused by the interference of the pathogenic agent in the development process, as Congenital Toxoplasmosis (hydrocephalus, cerebral calcification, mental retardation, acute myocarditis, retinochoroiditis, strabismus, microphthalmia ), Rubella Syndrome, congenital (deafness, congenital cataracts, heart defects, microcephaly and mental retardation) congenital Syphilis (bone deformities, keratitis, deafness and mental retardation), cytomegalovirus infection congenital (microcephaly, intracranial calcifications and sensorineural deafness), because these subjects they need special care medical and/or service people trained for the specific purposes.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention group

    Adolescent Obesity The exercise program, nutritional counseling and oral health will last for five to three months and will be held in the gym and rooms of the University of Santa Cruz do Sul (UNISC). The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.

    Behavioral: Physical Exercise

  • No intervention
    Control group

Interventions

  • BehavioralPhysical Exercise

    The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.

    Also known as: Nutritional counseling, Psychological counseling

06

What researchers measure

Primary outcomes

  1. Change from body mass index (BMI) at 3 months

    Weight and height will be evaluated early in the morning in a fasting state, with the student wearing light clothing and shoes. The BMI will be classified as normal BMI, overweight or obesity.The BMI will be classified according to the percentage curves of the Centers for Disease Control and Prevention / National Center for Health Statistics (CDC/NCHS) (2010) according to gender and age, considering the low weight (\<p5), normal weight (p5 and \<p85), overweight (p 85 and \<p 95) and obesity (p 95).

    Time frame: Baseline and 3 months.

Secondary outcomes

  1. Change from the percentage of body fat at 3 months

    To measure body fat percentage (BF%), a Lange (Beta Technology Incorporated) compass will be used to measure triceps and subscapular skinfolds. The equation of Slaughter et al. (1998) will be applied, and data will be classified according to Lonman's data, as mentioned by Heyward and Stolarczyk (2000).

    Time frame: Baseline and 3 months.

  2. Change from the waist circumference (WC) at 3 months

    Waist circumference (WC) was measured with an inelastic tape, using the narrowest part of the trunk between the ribs and the iliac crest and the hip at the greater trochanter level as references. The subjects were then classified according to Taylor et al. (2000), defining the normal circumference percentile as \<80 and obesity percentile as \>80 according to gender and age.

    Time frame: Baseline and 3 months.

07

Study locations

1 site
  • Universidade de Santa Cruz do Sul
    Santa Cruz do Sul, Rio Grande do Sul 96815900, Brazil
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Nov 2017, 3 months after the start.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 3 months is below that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Aug 31, 2017
StartActual
Aug 23, 2017
Primary completionEst.
Nov 23, 2017
CompletionEst.
Dec 8, 2017
Last update
Aug 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03269513
Lead sponsor
University of Santa Cruz do Sul
Responsible party
Miria Suzana Burgos (Principal Investigator, University of Santa Cruz do Sul) — Principal investigator
First posted
Aug 31, 2017
Start date
Aug 23, 2017
Primary completion
Nov 23, 2017 (estimated)
Completion
Dec 8, 2017 (estimated)
Last update
Aug 31, 2017

Study contacts

Miria S Burgos, Dra
principal investigator · Universidade de Santa Cruz do Sul

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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