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PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.

A Randomised Controlled Trial of a Program Based on the Theory of Planned Behaviour to Promote Fruit and Vegetables Intake Among Children. PROFRUVE Study Protocol.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03400891
Acronym
PROFRUVE
Enrollment
230
Registered
2018-01-17
Start date
2015-05-11
Completion date
2017-06-16
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Eating Behavior, Fruit and Vegetable Intake, Healthy Diet

Brief summary

Because fruit and vegetables (FV) intake of children of Vitoria city is low, a controlled intervention program was proposed at school level. The intervention was based on the Theory of Planned Behavior (TPB) as long as behavioral theories have been proved to be the most effective changing infant FV intake pattern. The main purpose of the study is to evaluate the effectiveness of an intervention program based on TPB and aimed to increase FV consumption in schoolchildren aged 8 to 10. For that aim, eligible classrooms from different schools were randomly assigned to the intervention (n=86) or control (n=86) group. The intervention group received 14 sessions of 60 minutes during 9 months of an academic year. Sessions, designed by a multidisciplinary team, are based on TPB and aimed to modify determinants of behavior (attitudes, subjective norms, perceived behavioral control, intention of consumption), and intake of FV itself. Change in fruit and vegetable intake and determinants of eating behavior were evaluated at 9 months of intervention using validated surveys, 7 day food records, 24 hour reminders and questionnaires. This study will provide a valid and useful tool to achieve changes in the consumption of FV at school level. A negative result will be useful to help redefining new strategies in the framework of changing habits in the consumption of FV.

Detailed description

In Vitoria, only two out of ten children and adolescents (aged 6 to 17) consume the recommended three servings of fruit and only one out of ten the recommended two servings of vegetables per day. Average intake of fruit was 1.8 servings/day and 0.8 servings/day for vegetables. For that reason, promotion of the adequate intake of FV must be a priority objective in the promotion of healthy eating habits. One of the most used theories in this type of interventions is TPB (Theory of Planned Behavior). According to this theory, eating behavior and intention of consumption determinants are both personal and environmental. Specifically, the TPB states that attitude, subjective norms and perceived control are determinants that influence both the intention to consume food and the action of consuming it. The hypothesis of the study is that an intervention program based on theories of behavior and aimed to increase FV intake in schoolchildren aged 8 to 10, will produce changes in attitude, subjective norms, perceived behavioral control and intention of eating fruit and vegetable among children, which in turn will modify the behavior, increasing FV intake. The main objective of this study is to evaluate the effectiveness of an intervention program based on behavioral theory and aimed to increase FV intake in schoolchildren aged 8 to 10 (short and long effect). Secondary objectives of the study are (i) to evaluate the change on FV intake on the study population after intervention, (ii) to examine the impact of the intervention program on behavioral determinants, (iii) to analyze the association of the determinants of behavior on FV intake, and (iv) to study the influence between social demographic variables and the effectiveness of the program. The recruitment of participants begun in may 2015 and they were randomly assigned to intervention or control groups. The intervention group received 14 sessions (one every 15 days) of one hour to work TPB constructs: attitude; subjective norms; perceived behavioural control and intention.

Interventions

BEHAVIORALProgram based on the theory of planned behaviour

14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.

Sponsors

University of the Basque Country (UPV/EHU)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* all schools with children aged 7-11 years old * schools with orchard

Exclusion criteria

* special schools * schools carrying out other healthy eating programs at the intervention period

Design outcomes

Primary

MeasureTime frameDescription
FV intakeChange from baseline food and vegetable intake at 9 months of interventionFruit and vegetable daily intake (servings/day)

Secondary

MeasureTime frameDescription
Eating behaviour determinant: Subjective NormsChange from baseline subjective norms at 9 months of interventionEvolution of subjective norms or social pressure related to eat more FV (1-5 point score, from totally disagree to totally agree)
Eating behaviour determinant: Perceived Behavioural ControlChange from baseline perceived behavioural control at 9 months of interventionEvolution of perceived behavioural control related to eat more FV (1-5 point score, from totally disagree to totally agree)
Eating behaviour determinant: AttitudeChange from baseline attitude at 9 months of interventionEvolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)
Social demographic outcomesChange from baseline social demographic outcomes at 9 months of interventionParticipants families social and demographic data
Parents FV intakeChange from parent's baseline food and vegetable intake at 9 months of interventionsParents fruits and vegetables daily intake (servings/day)
Eating behaviour determinant: IntentionChange from baseline intention at 9 months of interventionEvolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026