NCT03400891: PROFRUVE

PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.

Completed NA Last updated 17 January 2018

What this trial tests

NA trial testing Program based on the theory of planned behaviour in Eating Behavior in 230 participants. Completed in 16 June 2017.

Timeline

11 May 2015

Primary endpoint
16 June 2017

16 June 2017

Quick facts

Lead sponsor	University of the Basque Country (UPV/EHU)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	230
Start date	11 May 2015
Primary completion	16 June 2017
Estimated completion	16 June 2017

Drugs / interventions tested

• Program based on the theory of planned behaviour

Conditions studied

• Eating Behavior — all drugs for Eating Behavior →
• Healthy Diet — all drugs for Healthy Diet →
• Fruit and Vegetable Intake — all drugs for Fruit and Vegetable Intake →
• Childhood Obesity — all drugs for Childhood Obesity →

Sponsor

University of the Basque Country (UPV/EHU)

Who can join

Adults 7 to 11, any sex, with Eating Behavior or Healthy Diet. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A theory-based randomized controlled trial in promoting fruit and vegetable intake among schoolchildren: PROFRUVE study.
   Arrizabalaga-López M, Rada-Fernández de Jáuregui D, Portillo MDP, Mauleón JR, et al · · 2020 · cited 7× · PMID 32008063 · DOI 10.1007/s00394-020-02185-5
2. 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.
   Arrizabalaga-López M, Rada-Fernández de Jáuregui D, Portillo MP, Martínez O, et al · · 2018 · cited 4× · PMID 29973190 · DOI 10.1186/s12889-018-5748-3