Eating BehaviorPROFRUVENCT03400891
PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.
A study testing Program based on the theory of planned behaviour in people with Eating Behavior and Healthy Diet, run by University of the Basque Country (UPV/EHU).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Eating Behavior, Healthy Diet, Fruit and Vegetable Intake
- What is being tested?
- Program based on the theory of planned behaviour
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2015to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all schools with children aged 7-11 years old
- schools with orchard
Who cannot join
- special schools
- schools carrying out other healthy eating programs at the intervention period
About this study
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.
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.
Read the 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.
- Being tested
- Program based on the theory of planned behaviour
- Medical subject headings
- Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program based on the theory of planned behaviourBehavioural
14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Program based on the theory of planned behaviour |
| Control | No intervention | 2 session of 1 hour each to give general information about fruit and vegetables intake and health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FV intake
Fruit and vegetable daily intake (servings/day)
Measured: Change from baseline food and vegetable intake at 9 months of intervention
Secondary outcomes (6)
Eating behaviour determinant: Attitude
Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)
Measured: Change from baseline attitude at 9 months of intervention
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)
Measured: Change from baseline subjective norms at 9 months of intervention
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)
Measured: Change from baseline perceived behavioural control at 9 months of intervention
Eating behaviour determinant: Intention
Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)
Measured: Change from baseline intention at 9 months of intervention
Social demographic outcomes
Participants families social and demographic data
Measured: Change from baseline social demographic outcomes at 9 months of intervention
Parents FV intake
Parents fruits and vegetables daily intake (servings/day)
Measured: Change from parent's baseline food and vegetable intake at 9 months of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start11 May 2015
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Manuel Rodriguez Rivera, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400891
- Sponsor's protocol ID
- US14/15
- Acronym
- PROFRUVE
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
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.
PubMed 32008063Arrizabalaga-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.
PubMed 29973190
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03400891
- Acronym / sponsor ID
- PROFRUVE / US14/15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 11 May 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Program based on the theory of planned behaviourThis 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. |
| Control | No intervention | –2 session of 1 hour each to give general information about fruit and vegetables intake and health. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- all schools with children aged 7-11 years old
- schools with orchard
Key exclusion criteria (2 listed)
- special schools
- schools carrying out other healthy eating programs at the intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program based on the theory of planned behaviour14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention. | Behavioural | Intervention |
Primary outcome
FV intake
Time frame: Change from baseline food and vegetable intake at 9 months of intervention
Fruit and vegetable daily intake (servings/day)
6 secondary outcomes
Eating behaviour determinant: Attitude
Time frame: 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
Eating behaviour determinant: Perceived Behavioural Control
Time frame: 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
Social demographic outcomes
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Derived from this study: PubMed 32008063Arrizabalaga-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.
- Derived from this study: PubMed 29973190Arrizabalaga-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.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Program based on the theory of planned behaviour in people with Eating Behavior and Healthy Diet, run by University of the Basque Country (UPV/EHU).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FV intake (time frame: Change from baseline food and vegetable intake at 9 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.