Childhood ObesityEDAL2NCT01362023
Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2
A study testing lifestyle counseling in people with Childhood Obesity, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university… Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood 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
- 800 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to May 2013
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In the intervention group, all children of the selected classroom are exposed to the intervention.
- The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses.
- Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study.
Who cannot join
- No adequate age
- Lack of inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.
Read the detailed description
Initial pupil enrollment and continued for 3 years.
- Conditions
- Childhood Obesity
- Being tested
- lifestyle counseling
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle counselingBehavioural
Also called Childhood obesity
In 3 academic years, the intervention program consisted of three components:
- Classroom practice by HPA to highlight healthy lifestyle habits
- Teaching practice by HPA using books designed to include the nutritional objectives
- Parental activities included with their children
In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
- Experimental development of activities regarding each healthy lifestyle habit
- Assessment of activity performed in classroom
- An activity developed for use at home
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control pupils follow their usual activities |
| lifestyle counseling | Experimental | In 3 academic years, the intervention program consisted of three components:
1. Classroom practice by HPA to highlight healthy lifestyle habits
2. Teaching practice by HPA using books designed to include the nutritional objectives
3. Parental activities included with their children
In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
1. Experimental development of activities regarding each healthy lifestyle habit
2. Assessment of activity performed in classroom
3. An activity developed for use at home Receives: Behavioral: lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in prevalence of obesity
Primary outcomes include obesity (BMI ≥95th percentile) and overweight (BMI ≥85th percentile) We will analyzed obesity and overweight and a measure of thinness according to the Cole criteria as well as other measures of adiposity such as BMI z score and waist circumference. The numbers of subjects having a particular dietary habit are expressed as percentages of the total number of individuals being evaluated
Measured: Changes from baseline in prevalence of obesity at 3 academic years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Diputació de Tarragona
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Montse Giralt, Md, PhD, Principal investigator, Universitat Rovira i Virgili, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362023
- Sponsor's protocol ID
- YES
- Acronym
- EDAL2
- Status last verified
- Sep 2021
- First submitted
- 23 May 2011
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Llaurado E, Tarro L, Morina D, Queral R, Giralt M, Sola R. EdAl-2 (Educacio en Alimentacio) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. BMJ Open. 2014 Nov 20;4(11):e005496. doi: 10.1136/bmjopen-2014-005496.
PubMed 25412862
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01362023
- Acronym / sponsor ID
- EDAL2 / YES
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Diputació de Tarragona
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 May 2011 (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.
Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.
Detailed description
Initial pupil enrollment and continued for 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control pupils follow their usual activities |
| lifestyle counseling | Experimental | Behavioral: lifestyle counselingIn 3 academic years, the intervention program consisted of three components: 1. Classroom practice by HPA to highlight healthy lifestyle habits 2. Teaching practice by HPA using books designed to include the nutritional objectives 3. Parental activities included with their children In each of 12 activities (1 h/activity), the classroom practice consisted of three components: 1. Experimental development of activities regarding each healthy lifestyle habit 2. Assessment of activity performed in classroom 3. An activity developed for use at home |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- In the intervention group, all children of the selected classroom are exposed to the intervention.
- The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses.
- Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study.
Key exclusion criteria (2 listed)
- No adequate age
- Lack of inclusion criteria
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 counselingAlso: Childhood obesityIn 3 academic years, the intervention program consisted of three components: 1. Classroom practice by HPA to highlight healthy lifestyle habits 2. Teaching practice by HPA using books designed to include the nutritional objectives 3. Parental activities included with their children In each of 12 activities (1 h/activity), the classroom practice consisted of three components: 1. Experimental development of activities regarding each healthy lifestyle habit 2. Assessment of activity performed in classroom 3. An activity developed for use at home | Behavioural | lifestyle counseling |
Primary outcome
Reduction in prevalence of obesity
Time frame: Changes from baseline in prevalence of obesity at 3 academic years
Primary outcomes include obesity (BMI ≥95th percentile) and overweight (BMI ≥85th percentile) We will analyzed obesity and overweight and a measure of thinness according to the Cole criteria as well as other measures of adiposity such as BMI z score and waist circumference. The numbers of subjects having a particular dietary habit are expressed as percentages of the total number of individuals being evaluated
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 6 Oct 2021.
- Derived from this study: PubMed 25412862Llaurado E, Tarro L, Morina D, Queral R, Giralt M, Sola R. EdAl-2 (Educacio en Alimentacio) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. BMJ Open. 2014 Nov 20;4(11):e005496. doi: 10.1136/bmjopen-2014-005496.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, 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.
Montse Giralt, Md, PhD principal investigator
Universitat Rovira i Virgili, Spain
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 Childhood Obesity, run by University Rovira i Virgili at 1 site in Spain.
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 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 6 Oct 2021. 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 Spain. 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?
Reduction in prevalence of obesity (time frame: Changes from baseline in prevalence of obesity at 3 academic years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362023, which also lists 1 linked publication.
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 6 Oct 2021.