Viggiano 2015.

Study characteristics
Methods	Study design: cluster‐RCT Intervention period: 20 weeks Follow‐up period (post‐intervention): 1 month and 13 months Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: schools Unit of analysis: individual accounting for clustering
Participants	N (control baseline) = 1447 N (control follow‐up) = 421 N (intervention baseline) = 1663 N (intervention follow‐up) = 624 Setting (and number by study group): 20 middle/high schools; 10 intervention and 10 control Recruitment: 12 public middle schools and 8 public high schools were invited Geographic region: Campania, Italy Percentage of eligible population enrolled: 95% participants Mean age: intervention: 13.3 (13.2‐13.4); control: 13.0 (12.9‐13.04) Sex: intervention, 45% female; control, 49% female
Interventions	Aim: to confirm the effectiveness of Kaledo in improving nutritional knowledge and promoting long‐term healthy dietary behaviour in a large cohort study Kaledo is an educational board game. A typical game session requires 2‐4 players and lasts about 15–30 min. A game session represents a journey through daily meals of the Mediterranean diet. At the start, each player receives four chips and sets the energy expenditure of his/her kaleidoscope on the value corresponding to his/her Basal Metabolic Rate (BMR is obtained by consulting a simple table on the kaleidoscope which is based on age and weight). During a game session, the players move their pawns on the 59 boxes on the board and, consequently, they receive nutrition cards (common food items of Mediterranean diet) or activity cards (common daily activity) as indicated in the destination boxes. A player can refuse to take a card by leaving one chip. In this way, he can try to balance the total energy intake (EI) given by the nutrition cards with the total energy expenditure (EE) given by the activity cards and the BMR. At the end of the game, the winner is the person with maximum points calculated on the bases of energy balance (maximum 5 points), best food items (maximum 4 points), and food variety (maximum 1 point). 7 special boxes on the board act as a punishment or a reward during the game and they are associated with specific dietary behaviour in real life (e.g. a fast food lunch). Who delivered: children played themselves, aided by the classroom teacher. Training: before the beginning of the trial, teachers were trained to use the game and they were instructed to select different students to play the game together at each game session. Control group: the control group did not participate in any game session with Kaledo. Diet and PA intervention (board game) vs control
Outcomes	Outcome measures Primary outcome: score on the Adolescent Food Habits Checklist, scores on 6 sections of a dietary questionnaire (food habits, eating behaviour, nutrition knowledge), zBMI. Secondary outcomes: NR Process evaluation: NR
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender PROGRESS categories analysed at outcome: gender Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR
Notes	The pilot study is already included in this Cochrane Review: Amaro 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer generated list of random numbers with the restriction of balancing the number of middle and high schools between the two groups"
Allocation concealment (selection bias)	Unclear risk	NR
Blinding (performance bias and detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	High risk	High attrition; 35% in intervention and 25% in control at 6 months and 62% in intervention and 71% in control at 18 months
Selective reporting (reporting bias)	Unclear risk	Protocol and trial registry report sought but not found
Other bias	Low risk	No additional threats to validity
Other bias‐ timing of recruitment of clusters	Low risk	Schools were recruited before randomisation. Quote: "The 20 schools participating in the trial were randomly allocated to two independent groups by a computer‐generated list of random numbers with the restriction of balancing the number of middle and high schools between the two groups. Each group was then randomly assigned to a treatment condition."