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
About this trial
This is an interventional prevention trial for Eating Behavior
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
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
NCT ID
NCT03400891
First Posted
December 21, 2017
Last Updated
January 15, 2018
Sponsor
University of the Basque Country (UPV/EHU)
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
Learn more about this trial
PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.
We'll reach out to this number within 24 hrs