Trial Outcomes & Findings for Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study (NCT NCT01156805)

Results Overview

BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

509 participants

Primary outcome timeframe

every two years

Results posted on

2020-08-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Educational Intervention, Control 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	Non Intervention No intervention has been made.
Overall Study STARTED	237	272
Overall Study COMPLETED	181	216
Overall Study NOT COMPLETED	56	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Educational Intervention, Control n=237 Participants 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	Non Intervention n=272 Participants No intervention has been made.	Total n=509 Participants Total of all reporting groups
Age, Continuous Age	6.03 years STANDARD_DEVIATION 0.3 • n=5 Participants	6.03 years STANDARD_DEVIATION 0.3 • n=7 Participants	6.03 years STANDARD_DEVIATION 0.3 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	126 Participants n=7 Participants	234 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	146 Participants n=7 Participants	275 Participants n=5 Participants

PRIMARY outcome

Timeframe: every two years

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

BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.

Outcome measures

Outcome measures
Measure	Educational Intervention, Control n=272 Participants 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	Non Intervention n=237 Participants No intervention has been made.
Anthropometric Variables	16.4 kg/m^2 Standard Deviation 2.8	17.0 kg/m^2 Standard Deviation 2.4

SECONDARY outcome

Timeframe: every two years

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

Outcome measures

Outcome measures
Measure	Educational Intervention, Control n=272 Participants 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	Non Intervention n=237 Participants No intervention has been made.
Height	1.21 m Standard Deviation 0.06	1.19 m Standard Deviation 0.06

SECONDARY outcome

Timeframe: every two years

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

Outcome measures

Outcome measures
Measure	Educational Intervention, Control n=272 Participants 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	Non Intervention n=237 Participants No intervention has been made.
Father's Height	1.74 m Standard Deviation 0.07	1.75 m Standard Deviation 0.07

SECONDARY outcome

Timeframe: every two years

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

Outcome measures

Outcome measures
Measure	Educational Intervention, Control n=272 Participants 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	Non Intervention n=237 Participants No intervention has been made.
Mother's Height	1.61 m Standard Deviation 0.07	1.62 m Standard Deviation 0.07

Adverse Events

Educational Intervention, Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Esteve Llargues

Hospital General de Granollers

Phone: 938425000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place