Childhood Obesity Clinical Trial
— PROFRUVEOfficial title:
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.
Verified date | January 2018 |
Source | Basque Country University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 230 |
Est. completion date | June 16, 2017 |
Est. primary completion date | June 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 11 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basque Country University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FV intake | Fruit and vegetable daily intake (servings/day) | Change from baseline food and vegetable intake at 9 months of intervention | |
Secondary | Eating behaviour determinant: Attitude | Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree) | Change from baseline attitude at 9 months of intervention | |
Secondary | Eating behaviour determinant: Subjective Norms | Evolution of subjective norms or social pressure related to eat more FV (1-5 point score, from totally disagree to totally agree) | Change from baseline subjective norms at 9 months of intervention | |
Secondary | Eating behaviour determinant: Perceived Behavioural Control | Evolution of perceived behavioural control related to eat more FV (1-5 point score, from totally disagree to totally agree) | Change from baseline perceived behavioural control at 9 months of intervention | |
Secondary | Eating behaviour determinant: Intention | Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree) | Change from baseline intention at 9 months of intervention | |
Secondary | Social demographic outcomes | Participants families social and demographic data | Change from baseline social demographic outcomes at 9 months of intervention | |
Secondary | Parents FV intake | Parents fruits and vegetables daily intake (servings/day) | Change from parent's baseline food and vegetable intake at 9 months of interventions |
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