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PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children. (PROFRUVE)

Primary Purpose

Eating Behavior, Healthy Diet, Fruit and Vegetable Intake

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Program based on the theory of planned behaviour
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Behavior

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    This group received 14 sessions (one every 15 days) of one hour in the classroom, to work TPB constructs: attitude; subjective norms; perceived behavioural control and intention.

    2 session of 1 hour each to give general information about fruit and vegetables intake and health.

    Outcomes

    Primary Outcome Measures

    FV intake
    Fruit and vegetable daily intake (servings/day)

    Secondary Outcome Measures

    Eating behaviour determinant: Attitude
    Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)
    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)
    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)
    Eating behaviour determinant: Intention
    Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)
    Social demographic outcomes
    Participants families social and demographic data
    Parents FV intake
    Parents fruits and vegetables daily intake (servings/day)

    Full Information

    First Posted
    December 21, 2017
    Last Updated
    January 15, 2018
    Sponsor
    University of the Basque Country (UPV/EHU)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03400891
    Brief Title
    PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.
    Acronym
    PROFRUVE
    Official 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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 11, 2015 (Actual)
    Primary Completion Date
    June 16, 2017 (Actual)
    Study Completion Date
    June 16, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of the Basque Country (UPV/EHU)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Behavior, Healthy Diet, Fruit and Vegetable Intake, Childhood Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    230 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    This group received 14 sessions (one every 15 days) of one hour in the classroom, to work TPB constructs: attitude; subjective norms; perceived behavioural control and intention.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    2 session of 1 hour each to give general information about fruit and vegetables intake and health.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Program based on the theory of planned behaviour
    Intervention Description
    14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.
    Primary Outcome Measure Information:
    Title
    FV intake
    Description
    Fruit and vegetable daily intake (servings/day)
    Time Frame
    Change from baseline food and vegetable intake at 9 months of intervention
    Secondary Outcome Measure Information:
    Title
    Eating behaviour determinant: Attitude
    Description
    Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)
    Time Frame
    Change from baseline attitude at 9 months of intervention
    Title
    Eating behaviour determinant: Subjective Norms
    Description
    Evolution of subjective norms or social pressure related to eat more FV (1-5 point score, from totally disagree to totally agree)
    Time Frame
    Change from baseline subjective norms at 9 months of intervention
    Title
    Eating behaviour determinant: Perceived Behavioural Control
    Description
    Evolution of perceived behavioural control related to eat more FV (1-5 point score, from totally disagree to totally agree)
    Time Frame
    Change from baseline perceived behavioural control at 9 months of intervention
    Title
    Eating behaviour determinant: Intention
    Description
    Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)
    Time Frame
    Change from baseline intention at 9 months of intervention
    Title
    Social demographic outcomes
    Description
    Participants families social and demographic data
    Time Frame
    Change from baseline social demographic outcomes at 9 months of intervention
    Title
    Parents FV intake
    Description
    Parents fruits and vegetables daily intake (servings/day)
    Time Frame
    Change from parent's baseline food and vegetable intake at 9 months of interventions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared
    Citations:
    PubMed Identifier
    32008063
    Citation
    Arrizabalaga-Lopez M, Rada-Fernandez de Jauregui D, Portillo MDP, Mauleon JR, Martinez O, Etaio I, Tormo-Santamaria M, Bernabeu-Maestre J, Rodriguez VM. A theory-based randomized controlled trial in promoting fruit and vegetable intake among schoolchildren: PROFRUVE study. Eur J Nutr. 2020 Dec;59(8):3517-3526. doi: 10.1007/s00394-020-02185-5. Epub 2020 Feb 1.
    Results Reference
    derived
    PubMed Identifier
    29973190
    Citation
    Arrizabalaga-Lopez M, Rada-Fernandez de Jauregui D, Portillo MP, Martinez O, Etaio I, Mauleon JR, Echevarria E, Gomez F, Rodriguez VM. A randomised controlled trial of a program based on the theory of planned behavior to promote fruit and vegetable intake among schoolchildren: PROFRUVE study protocol. BMC Public Health. 2018 Jul 4;18(1):827. doi: 10.1186/s12889-018-5748-3.
    Results Reference
    derived

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