Childhood ObesityOTPACONCT02453269
Transdisciplinary Program Against Childhood Obesity
A study testing Transdisciplinary program in people with Childhood Obesity, run by Fortaleza University at 1 site in Brazil.
Trial summary
The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program against childhood obesity. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Transdisciplinary program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Carminda Maria Goersch Fontenele Lamboglia
Fortaleza, Ceará, 60.811-905
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Transdisciplinary program
- Keywords
- Obesity, Children, Health Colective
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdisciplinary programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Transdisciplinary program | Experimental | 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). Receives: Behavioral: Transdisciplinary program |
| Control group | No intervention | The children in the control group (G2) were not exposed to interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height (cm) (outcome)
Measured: Participants were followed for the duration of one year
Body mass (kg) (outcome)
Measured: Participants were followed for the duration of one year
Body mass index (kg/m2) (outcome)
Measured: Participants were followed for the duration of one year
Waist circumference (cm) (outcome)
Measured: Participants were followed for the duration of one year
Waist circunference/height ratio (outcome)
Measured: Participants were followed for the duration of one year
Body fat percentage (%) (outcome)
Measured: Participants were followed for the duration of one year
Fat body mass (kg) (outcome)
Measured: Participants were followed for the duration of one year
Lean body mass (kg) (outcome)
Measured: Participants were followed for the duration of one year
Abdominal strength (repetition) (outcome)
Measured: Participants were followed for the duration of one year
Flexibility (cm) (outcome)
Measured: Participants were followed for the duration of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carminda Maria Goersch Fontenele Lamboglia, Fortaleza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453269
- Sponsor's protocol ID
- TRANS 123
- Acronym
- OTPACO
- Status last verified
- May 2015
- First submitted
- 13 Apr 2015
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a 1-year Transdisciplinary Program Against Childhood Obesity
- ClinicalTrials.gov ID
- NCT02453269
- Acronym / sponsor ID
- OTPACO / TRANS 123
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Children, Health Colective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program against childhood obesity.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdisciplinary program | Experimental | Behavioral: Transdisciplinary programChildren 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). |
| Control group | No intervention | –The children in the control group (G2) were not exposed to interventions. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- To be eligible for the study, children should
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdisciplinary program | Behavioural | Transdisciplinary program |
Primary outcome
Height (cm) (outcome)
Time frame: Participants were followed for the duration of one year
Body mass (kg) (outcome)
Time frame: 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
Waist circumference (cm) (outcome)
Time frame: 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
Body fat percentage (%) (outcome)
Time frame: 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
Lean body mass (kg) (outcome)
Time frame: Participants were followed for the duration of one year
Abdominal strength (repetition) (outcome)
Time frame: Participants were followed for the duration of one year
Flexibility (cm) (outcome)
Time frame: Participants were followed for the duration of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdisciplinary program in people with Childhood Obesity, run by Fortaleza University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (cm) (outcome) (time frame: Participants were followed for the duration of one year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015; AzTrials last refreshed its copy on 3 Nov 2026.