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. 2019 Jul 23;2019(7):CD001871. doi: 10.1002/14651858.CD001871.pub4

Sevinc 2011.

Study characteristics
Methods Study design: cluster‐RCT
Intervention period: 8 months
Follow‐up period (post‐intervention): nil
Differences in baseline characteristics: reported
Reliable outcomes: reported
Protection against contamination: NR
Unit of allocation: group (2 schools in each group)
Unit of analysis: individual
Participants N (controls baseline) = 2926
N (controls follow‐up) = 2654
N (intervention 1 baseline) = 1932
N (intervention 1 follow‐up) = 1897
N (intervention 2 baseline) = 1989
N (intervention 2 follow‐up) = 1815
Setting (and number by study group): schools, intervention 1 (N = 2), intervention 2 (N = 2), control (N = 2). Each group comprised of one low‐SES and one high‐SES school
Recruitment: all schools involved in a half‐day education system; randomly sampled
Geographic region: Denizli, Turkey
Percentage of eligible population enrolled: 98.9% participants
Mean age: (intervention + control): 7‐13 years
Sex: intervention 1: 50.3% female; intervention 2: 49.8% female; control: 49.1% female
Interventions Aim: to determine the efficiency of applying both PA and healthy nutrition programmes and only a healthy nutrition programme for preventing obesity in primary school students (aged 7‐13) in Denizli, to determine the relationship of this efficiency with the possible variables, and to construct an obesity control programme aimed at the students.
Associated study name: Get into motion for health
Intervention description
Intervention group 1: PA combined with healthy nutrition education programme. Initial weekly PE classes were 2 h in total and increased to 3 h on different days of the week. During these sessions standard PA and sport programmes, specific to the age range of the children were applied. Does not state who delivered the PA programme.
Intervention group 2: healthy nutrition education programme only. Education on the importance of healthy nutrition and the methods of preventing obesity were given to the students, their parents, and the teachers. Boxed milk was also distributed to the students for them to drink during meal time. Moreover, to supply healthy eating options for the students in the school canteens, water, freshly squeezed fruit juice, buttermilk, milk and seasonal fruits were sold.
Who delivered/training: personnel of the Health Training Division of the City Health Administration/teachers
Diet and PA combination intervention vs dietary intervention only vs control
PA intervention vs control (health education)
Outcomes Outcome measures
  • Primary outcome: BMI

  • 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; parent: SES (income)
PROGRESS categories analysed at outcome: gender; parent: SES (income)
Outcomes relating to harms/unintended effects: NR
Intervention included strategies to address diversity or disadvantage: targeted both low‐ and high‐SES schools
Economic evaluation: NR
Notes Funding: NR
In one of the schools in intervention group 1, some of the equipment required for the PA programme could not be obtained, and an insufficiency in directing the school canteens to supply healthy food instead of fast food and carbonated drinks might be counted among the limitations of the study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk From the low‐ and high‐value SES regions, 3 schools each (a total of 6 schools) were selected by using a simple random sampling method. These schools were randomly divided into 3 groups consisting of 1 school from the low‐ and 1 school from the high‐SES level. Of these groups, 2 were again randomly selected as intervention groups and the remaining 1 as the control group
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 Low risk 94% retention of those ‘reached’
Selective reporting (reporting bias) Unclear risk Protocol or trial register not found
Other bias Low risk No additional threats to validity
Other bias‐ timing of recruitment of clusters Low risk Figures suggest recruitment happened prior to randomisation