PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.

NCT03400891 | Completed

• 1 other identifier: US14/15
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eating Behavior; Healthy Diet; Fruit and Vegetable Intake; Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• FV intake

  Fruit and vegetable daily intake (servings/day)

  Change from baseline food and vegetable intake at 9 months of intervention

Secondary Outcomes (6)

• Eating behaviour determinant: Attitude

  Change from baseline attitude at 9 months of intervention

• Eating behaviour determinant: Subjective Norms

  Change from baseline subjective norms at 9 months of intervention

• Eating behaviour determinant: Perceived Behavioural Control

  Change from baseline perceived behavioural control at 9 months of intervention

• Eating behaviour determinant: Intention

  Change from baseline intention at 9 months of intervention

• Social demographic outcomes

  Change from baseline social demographic outcomes at 9 months of intervention

Study Arms (2)

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.

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.

Interventions

Program based on the theory of planned behaviour BEHAVIORAL

14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.

Intervention

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all schools with children aged 7-11 years old
• schools with orchard

You may not qualify if:

• special schools
• schools carrying out other healthy eating programs at the intervention period

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Related Publications (2)

• 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.

  PMID: 32008063 DERIVED

• 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.

  PMID: 29973190 DERIVED

MeSH Terms

Conditions

Feeding Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 17, 2018
• Study Start: May 11, 2015
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share