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

January 15, 2018 updated by: Victor Manuel Rodriguez Rivera, University of the Basque Country (UPV/EHU)

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FV intake
Time Frame: Change from baseline food and vegetable intake at 9 months of intervention
Fruit and vegetable daily intake (servings/day)
Change from baseline food and vegetable intake at 9 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline attitude at 9 months of intervention
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)
Change from baseline subjective norms at 9 months of intervention
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)
Change from baseline perceived behavioural control at 9 months of intervention
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)
Change from baseline intention at 9 months of intervention
Social demographic outcomes
Time Frame: Change from baseline social demographic outcomes at 9 months of intervention
Participants families social and demographic data
Change from baseline social demographic outcomes at 9 months of intervention
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)
Change from parent's baseline food and vegetable intake at 9 months of interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2015

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

June 16, 2017

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US14/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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