ObesityAVALLNCT01156805
Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study
A study testing Educational program in people with Obesity and Food Habits, run by Hospital de Granollers.
Trial summary
The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Obesity, Food Habits, Physical Activity
- What is being tested?
- Educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born in 2000 who attended schools in Granollers City
Who cannot join
- Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued
About this study
Official title: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.
The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.
Read the detailed description
A two-year cluster-randomised prospective study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling (5-6 years of age) in schools in the city of Granollers. The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test.
- Conditions
- Obesity, Food Habits, Physical Activity
- Being tested
- Educational program
- Keywords
- Children, School-based program, Obesity
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programOther
The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention, Control | Experimental | Experimental, intervention group has received specific educational training to improve food habits and physical activity during the period of the study. Receives: Other: Educational program |
| Educational program | No intervention | No intervention has been made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Variables
BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.
Measured: every two years
Secondary outcomes (3)
Height
Measured: every two years
Father's Height
Measured: every two years
Mother's Height
Measured: every two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assumpta Recasens, MD, Study director, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156805
- Sponsor's protocol ID
- AVALL
- Acronym
- AVALL
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2010
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Recasens MA, Xicola-Coromina E, Manresa JM, Ullmo PA, Jensen BB, Franco R, Suarez A, Nadal A, Vila M, Recasens I, Perez MJ, Castell C, Llargues E. Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study). Clin Nutr. 2019 Dec;38(6):2592-2598. doi: 10.1016/j.clnu.2018.12.029. Epub 2019 Jan 24.
PubMed 30737048Llargues E, Recasens MA, Manresa JM, Jensen BB, Franco R, Nadal A, Vila M, Recasens I, Perez MJ, Castell C. Four-year outcomes of an educational intervention in healthy habits in schoolchildren: the Avall 3 Trial. Eur J Public Health. 2017 Feb 1;27(1):42-47. doi: 10.1093/eurpub/ckw199. No abstract available.
PubMed 28177448
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.
- ClinicalTrials.gov ID
- NCT01156805
- Acronym / sponsor ID
- AVALL / AVALL
- Conditions
- Obesity, Food Habits, Physical Activity
- Keywords
- Children, School-based program, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.
Detailed description
A two-year cluster-randomised prospective study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling (5-6 years of age) in schools in the city of Granollers. The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention, Control | Experimental | Other: Educational programExperimental, intervention group has received specific educational training to improve food habits and physical activity during the period of the study. |
| Educational program | No intervention | –No intervention has been made. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children born in 2000 who attended schools in Granollers City
Key exclusion criteria (1 listed)
- Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued
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 |
|---|---|---|
| Educational programThe intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test | Other | Educational intervention, Control |
Primary outcome
Anthropometric Variables
Time frame: every two years
BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.
3 secondary outcomes
Height
Time frame: every two years
Father's Height
Time frame: every two years
Mother's Height
Time frame: every two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30737048Recasens MA, Xicola-Coromina E, Manresa JM, Ullmo PA, Jensen BB, Franco R, Suarez A, Nadal A, Vila M, Recasens I, Perez MJ, Castell C, Llargues E. Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study). Clin Nutr. 2019 Dec;38(6):2592-2598. doi: 10.1016/j.clnu.2018.12.029. Epub 2019 Jan 24.
- Derived from this study: PubMed 28177448Llargues E, Recasens MA, Manresa JM, Jensen BB, Franco R, Nadal A, Vila M, Recasens I, Perez MJ, Castell C. Four-year outcomes of an educational intervention in healthy habits in schoolchildren: the Avall 3 Trial. Eur J Public Health. 2017 Feb 1;27(1):42-47. doi: 10.1093/eurpub/ckw199. No abstract available.
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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.
Assumpta Recasens, MD study director
Hospital de Granollers
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Obesity and Food Habits, run by Hospital de Granollers.
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 1 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: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anthropometric Variables (time frame: every two 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 NCT01156805, which also lists 2 linked publications.
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 17 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.