OverweightCRECESNCT02104973
Obesity Prevention in Schoolchildren
A study testing Lifestyle counseling in people with Overweight and Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Feb 2015
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children students in selected schools
- Anthropometric diagnostic of normality or overweight
- Informed consent of parents
Who cannot join
- Children with special diet or children with limited motor functioning
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720
About this study
Official title: Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.
Read the detailed description
In Mexico, obesity is becoming the most public health problem. The increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. Schools, as social settings, are a opportunity for obesity prevention.
The study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. The evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. The intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and Provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle counseling
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
We will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | After obtaining the approval of schools and parents, will be established in schools, units in which individual attention is given to children, parents and teachers that request: the advice is aimed at training users on healthy diet and constant physical activity. Workshops with children, in which selected topics will be discussed based on the analysis of depth interviews with children, parents and teachers, and information on habits and resources gathered through questionnaires will be conducted. The intervention included the provision of information and feedback with the population through a website. The work will include participation in the selection of foods sold in schools. Receives: Behavioral: Lifestyle counseling |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
We will evaluate the change in body mass index
Measured: 0, 12 months
Secondary outcomes (1)
Change in vegetal and fruit consumption
We will evaluate the change in frequency of consumption of diverse fruits and vegetables
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Secretaria de Salud, Mexico, Secretaría de Educación Pública, México, Universidad Iberoamericana
- Responsible party
- Sponsor
- Investigators
- Marco A González, Master, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104973
- Sponsor's protocol ID
- 2007-785-060
- Other IDs
- 2007-01-68854
- Acronym
- CRECES
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
- ClinicalTrials.gov ID
- NCT02104973
- Acronym / sponsor ID
- CRECES / 2007-785-060
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Secretaria de Salud, Mexico, Secretaría de Educación Pública, México, Universidad Iberoamericana
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2015 (estimated)
- First posted
- 7 Apr 2014 (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 is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.
Detailed description
In Mexico, obesity is becoming the most public health problem. The increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. Schools, as social settings, are a opportunity for obesity prevention.
The study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. The evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. The intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and Provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingAfter obtaining the approval of schools and parents, will be established in schools, units in which individual attention is given to children, parents and teachers that request: the advice is aimed at training users on healthy diet and constant physical activity. Workshops with children, in which selected topics will be discussed based on the analysis of depth interviews with children, parents and teachers, and information on habits and resources gathered through questionnaires will be conducted. The intervention included the provision of information and feedback with the population through a website. The work will include participation in the selection of foods sold in schools. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children students in selected schools
- Anthropometric diagnostic of normality or overweight
- Informed consent of parents
Key exclusion criteria (1 listed)
- Children with special diet or children with limited motor functioning
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 |
|---|---|---|
| Lifestyle counselingWe will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption. | Behavioural | Lifestyle counseling |
Primary outcome
Body mass index
Time frame: 0, 12 months
We will evaluate the change in body mass index
1 secondary outcome
Change in vegetal and fruit consumption
Time frame: 0, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Obesity
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.
Marco A González, Master principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Overweight and Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2014. 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 Mexico. 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?
Results are not available in the source record.
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?
Body mass index (time frame: 0, 12 months). 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 7 Apr 2014.