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

Abstract

BackgroundThe PROFRUVE study is a controlled intervention based on the Theory of Planned Behavior (TPB), which follows those behavioral theories that have proved to be the most effective at changing infant fruit and vegetable (FV) intake pattern. The main purpose of the study is to evaluate the effectiveness of an intervention program in increasing FV consumption in schoolchildren aged 8 to 10 and based on TPB.MethodsEligible classrooms within schools from Vitoria-Gasteiz (Basque Country, Spain) will be randomly assigned to the intervention (classrooms n = 4; children n = 86) or control (classrooms n = 4; children n = 86) group. The intervention group will receive 14 sessions of 60 min during an academic year (October to June). These sessions, designed by a multidisciplinary team, are based on TPB and are directed at modifying determinants of behavior (attitudes, subjective norms, perceived behavioral control and intention of consumption), and intake of FV itself. Both the process and the evolution of consumption and determinants of behavior will be evaluated (before, during, shortly after and a year after) using validated surveys, 7 day food records, 24 h reminders and questionnaires.DiscussionThis study will provide a valid and useful tool to achieve changes in the consumption of FV at school level. A negative result will be helpful in redefining new strategies in the framework of changing habits in the consumption of FV.Trial RegistrationThis study has been retrospectively registered at ClinicalTrials.gov. Identifier: NCT03400891. Data registered: 17/01/2018.

Evaluating OzHarvest’s primary-school Food Education and Sustainability Training (FEAST) program in 10–12-year-old children in Australia: protocol for a pragmatic cluster non-randomized controlled trial

“…Standard deviations for vegetable and fruit serves/day are estimated to be 1.3 and 1.1 respectively, according to the South Australian Health Reports from 2015 on children’s vegetable intake [ 74 ] and fruit intake [ 75 ]. Allowance will be made for 20% loss due to follow-up or missing data [ 72 , 76 ].…”

A theory-based randomized controlled trial in promoting fruit and vegetable intake among schoolchildren: PROFRUVE study

“…A cluster randomized controlled community trial was carried out over an academic year at school level in Vitoria-Gasteiz, the capital of the Basque Country. Clustering of classrooms from the same school was performed as previously described in the study protocol [20]. Clustering was chosen because this is the easiest way to implement an intervention program at school level.…”

“…Following the published study protocol [20], sample size was calculated to provide a power of 90% to detect an effect size (Cohen´s d) of at least 0.5 servings/day: 172 participants (86 in the intervention group and 86 in the control group) were required. Taking into account the dropout rate of similar studies [21][22][23], the final sample size was increased by 20% to reach 206 children (8 classrooms with a minimum of 26 children per class).…”

“…Identifier: NCT03400891. Data registered 17/01/2018 Protocol: The study protocol was published elsewhere: https://doi.org/10.1186/s12889-018-5748-3 [20].…”