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Trial record 1 of 1 for:    NCT03400891
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PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children. (PROFRUVE)

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ClinicalTrials.gov Identifier: NCT03400891
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Victor Manuel Rodriguez Rivera, Basque Country University

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.

Condition or disease Intervention/treatment Phase
Eating Behavior Healthy Diet Fruit and Vegetable Intake Childhood Obesity Behavioral: Program based on the theory of planned behaviour Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Program based on the theory of planned behaviour
14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.

No Intervention: Control
2 session of 1 hour each to give general information about fruit and vegetables intake and health.



Primary Outcome Measures :
  1. FV intake [ Time Frame: Change from baseline food and vegetable intake at 9 months of intervention ]
    Fruit and vegetable daily intake (servings/day)


Secondary Outcome Measures :
  1. Eating behaviour determinant: Attitude [ Time Frame: Change from baseline attitude at 9 months of intervention ]
    Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)

  2. Eating behaviour determinant: Subjective Norms [ Time Frame: Change from baseline subjective norms at 9 months of intervention ]
    Evolution of subjective norms or social pressure related to eat more FV (1-5 point score, from totally disagree to totally agree)

  3. Eating behaviour determinant: Perceived Behavioural Control [ Time Frame: Change from baseline perceived behavioural control at 9 months of intervention ]
    Evolution of perceived behavioural control related to eat more FV (1-5 point score, from totally disagree to totally agree)

  4. Eating behaviour determinant: Intention [ Time Frame: Change from baseline intention at 9 months of intervention ]
    Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)

  5. Social demographic outcomes [ Time Frame: Change from baseline social demographic outcomes at 9 months of intervention ]
    Participants families social and demographic data

  6. Parents FV intake [ Time Frame: Change from parent's baseline food and vegetable intake at 9 months of interventions ]
    Parents fruits and vegetables daily intake (servings/day)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Victor Manuel Rodriguez Rivera, Doctor, Basque Country University
ClinicalTrials.gov Identifier: NCT03400891    
Other Study ID Numbers: US14/15
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight