- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453269
Transdisciplinary Program Against Childhood Obesity (OTPACO)
May 20, 2015 updated by: Carminda Maria Goersch Fontenele Lamboglia, Fortaleza University
Outcome of a 1-year Transdisciplinary Program Against Childhood Obesity
The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program against childhood obesity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was quasi-experimental with a quantitative approach.5
Epidemiologically, the study may be characterized as a controlled, randomized trial.
Twenty participants were selected non-randomly from an elementary school in Fortaleza, Brazil.
The parents or caretakers of the participants gave their informed written consent.
The 20 participants were distributed randomly into two groups, G1 (intervention, n=10) and G2 (control, n=10).
Six children did not complete the study protocol: three in G1 due to insufficient attendance, and three in G2 for unspecified reasons.
To be eligible for the study, children should i) be overweight or obese in accordance with the definition given above6, ii) be considered healthy by a physician after undergoing a clinical examination, iii) attend the transdisciplinary intervention sessions once a week (minimum attendance required: 90%) and iv) be authorized to participate by their parents or caretakers.
The children in the control group were not submitted to the intervention and were not participating in any other program involving obesity control or supervised physical activity.
All children (G1+G2) were instructed to maintain their habitual level of physical activity and attend the school's regular physical education classes.
The latter were scheduled twice a month during the first term and four times a month during the second.
The decision to increase the frequency was made by the school's director in acknowledgment of the importance of physical activity, but the change affected the two groups equally.
Children were ineligible if they had chronic diseases (defined as diseases requiring continuous therapy), mental disorders or cognitive impairments which might interfere with communication, or used a pacemaker, or declined participation.
Children in G1 missing more than 10% of the total intervention sessions were excluded from the sample.
The study was conducted at an elementary school in Fortaleza, Brazil, maintained by the Edson Queiroz Foundation/UNIFOR.
Data were collected at baseline in May 2013 (pre-test) and after one year of intervention, in May 2014 (post-test), as part of the transdisciplinary program against childhood obesity.
Children in G1 were submitted to a transdisciplinary intervention once a week.
Each child received a nutritional education kit including four games ("Cool Diet", a board game, a memory game and a word search puzzle) and an interactive booklet containing illustrations of foods selected from the participants' cultural context (Northeastern Brazil).
The kit was validated by Munguba.
The children in the control group (G2) were not exposed to interventions during the study period.
They attended the school's regular physical education classes, but were excluded from the sample if they joined any other physical activity or weight control program.
At the end of the study, the children in G2 received the booklet described above, including the results of the physical fitness evaluation.
Talks about the importance of physical activity and healthy food in this group were scheduled for early 2015.
Upon the first visit, all participants were given a physical evaluation (BMI, height and waist circumference) following the procedures standardized by Lohman, Roche and Martorell.
The body composition was determined by bioelectrical impedance (Bodystat 1500 MMD) upon the second visit.
Upon the first, the children were instructed in how to prepare for the test: abstain from food and drink (4 hours before), exercise (12 hours before), alcohol (24 hours before) and diuretic medication (7 days before), and urinate 30 min before the test.
The subject is measured lying down, with electrodes attached to hands and feet.
The muscular fitness assessment was based on FitnessGram®, a criterion-referenced test, but was limited to flexibility and abdominal muscle strength/endurance.
The evaluation of sexual maturity was based on the age at menarche in girls and on armpit hair development in boys.
The purpose of this evaluation was to identify each participant's stage of growth, development and maturity.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ceará
-
Fortaleza, Ceará, Brazil, 60.811-905
- Carminda Maria Goersch Fontenele Lamboglia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
To be eligible for the study, children should
- be overweight or obese in accordance with the definition given above6,
- be considered healthy by a physician after undergoing a clinical examination,
- attend the transdisciplinary intervention sessions once a week (minimum attendance required: 90%)
- be authorized to participate by their parents or caretakers.
- The children in the control group were not submitted to the intervention and were not participating in any other program involving obesity control or supervised physical activity.
- All children (G1+G2) were instructed to maintain their habitual level of physical activity and attend the school's regular physical education classes.
- The latter were scheduled twice a month during the first term and four times a month during the second.
- The decision to increase the frequency was made by the school's director in acknowledgment of the importance of physical activity, but the change affected the two groups equally.
Exclusion Criteria:
- Children were ineligible if they had chronic diseases (defined as diseases requiring continuous therapy), mental disorders or cognitive impairments which might interfere with communication, or used a pacemaker, or declined participation.
- Children in G1 missing more than 10% of the total intervention sessions were excluded from the sample.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transdisciplinary program
Children in G1 were submitted to a transdisciplinary intervention once a week.
Each child received a nutritional education kit including four games ("Cool Diet", a board game, a memory game and a word search puzzle) and an interactive booklet containing).
|
|
|
No Intervention: Control group
The children in the control group (G2) were not exposed to interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Height (cm) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Body mass (kg) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Body mass index (kg/m2) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Waist circumference (cm) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Waist circunference/height ratio (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Body fat percentage (%) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Fat body mass (kg) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Lean body mass (kg) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Abdominal strength (repetition) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
|
Flexibility (cm) (outcome)
Time Frame: Participants were followed for the duration of one year
|
Participants were followed for the duration of one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
April 13, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 25, 2015
Study Record Updates
Last Update Posted (Estimate)
May 25, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRANS 123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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