AVALL: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study

• Sponsor: Hospital de Granollers (Other)
• Overall Status: Completed
• CT.gov ID: NCT01156805
• Collaborator: (none)
• Enrollment: 509
• Arms: 2
• Duration (Months): 72

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Food Habits; Physical Activity	Other: Educational program	N/A

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

• Study Type: Interventional
• Actual Enrollment: 509 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Educational intervention, Control Experimental, intervention group has received specific educational training to improve food habits and physical activity during the period of the study.	Other: Educational program; 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
No Intervention: Educational program No intervention has been made.

Outcome Measures

Primary Outcome Measures

1. Anthropometric Variables [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.

Secondary Outcome Measures

1. Height [every two years]

2. Father's Height [every two years]

3. Mother's Height [every two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children born in 2000 who attended schools in Granollers City

Exclusion Criteria:

• Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital de Granollers

Investigators

• Study Director: Assumpta Recasens, MD, Hospital de Granollers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital de Granollers
• ClinicalTrials.gov Identifier: NCT01156805
• Other Study ID Numbers: AVALL
• First Posted: Jul 5, 2010
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2017

• Keywords provided by Hospital de Granollers: Children; School-based program; Obesity
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	In 2006, the 16 schools in Granollers were randomly distributed to the intervention or control group stratified according to public or semi-private status, number of first-year's classrooms and socioeconomic status of the local neighborhood.

Arm/Group Title	Educational Intervention, Control	Non Intervention
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.
Period Title: Overall Study
STARTED	237	272
COMPLETED	181	216
NOT COMPLETED	56	56

Baseline Characteristics

Arm/Group Title	Educational Intervention, Control	Non Intervention	Total
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.	Total of all reporting groups
Overall Participants	237	272	509
Age (years) [Mean (Standard Deviation) ]
Age	6.03 (0.3)	6.03 (0.3)	6.03 (0.3)
Sex: Female, Male (Count of Participants)
Female	108 45.6%	126 46.3%	234 46%
Male	129 54.4%	146 53.7%	275 54%

Outcome Measures

1. Primary Outcome

Title	Anthropometric Variables
Description	BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.
Time Frame	every two years

Outcome Measure Data

Analysis Population Description

Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.

Arm/Group Title	Educational Intervention, Control	Non Intervention
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.
Measure Participants	272	237
Mean (Standard Deviation) [kg/m^2]	16.4 (2.8)	17.0 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Educational Intervention, Control, Non Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time

2. Secondary Outcome

Title	Height
Time Frame	every two years

Outcome Measure Data

Analysis Population Description

Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD

Arm/Group Title	Educational Intervention, Control	Non Intervention
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.
Measure Participants	272	237
Mean (Standard Deviation) [m]	1.21 (0.06)	1.19 (0.06)

3. Secondary Outcome

Title	Father's Height
Time Frame	every two years

Outcome Measure Data

Analysis Population Description

Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.

Arm/Group Title	Educational Intervention, Control	Non Intervention
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.
Measure Participants	272	237
Mean (Standard Deviation) [m]	1.74 (0.07)	1.75 (0.07)

4. Secondary Outcome

Title	Mother's Height
Time Frame	every two years

Outcome Measure Data

Analysis Population Description

Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.

Arm/Group Title	Educational Intervention, Control	Non Intervention
Arm/Group Description	Experimental, intervention group has received educational training to improve food habits and physical activity Educational program: 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	No intervention has been made.
Measure Participants	272	237
Mean (Standard Deviation) [m]	1.61 (0.07)	1.62 (0.07)

Adverse Events

Arm/Group Title	Educational Intervention, Control		Non Intervention
Arm/Group Description	No untoward or unfavorable medical occurrence in a participants. There's no medication		No intervention has been made.
All Cause Mortality
	Educational Intervention, Control		Non Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/237 (0%)		0/272 (0%)
Serious Adverse Events
	Educational Intervention, Control		Non Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/237 (0%)		0/272 (0%)
Other (Not Including Serious) Adverse Events
	Educational Intervention, Control		Non Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/237 (0%)		0/272 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.