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Table 5 Primary outcomes: pre-randomisation proportions, outcome proportions and risk differences adjusted for stratification factors

From: A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

  Pre-randomisationa (%) Unadjusted model estimatesb Adjusted model estimatesbc
  Outcome (%) RD (95% CI) p-value RD (95% CI) p-value ICC
Primary outcome 1: enrolment
 HENRY alone (n = 10 local authorities) 50.0 18.0 −0.3 (−19.1, 18.6) 0.978 −1.2 (−19.5, 17.1) 0.886 0.136
 HENRY + optimisation intervention (n = 10 local authorities) 60.0 17.8      
Primary outcome 2: attendance
 HENRY alone (n = 10 local authorities) 50.0 13.9 3.1 (−13.3, 19.6) 0.695 1.2 (−15.7, 18.1) 0.881 < 0.001
 HENRY + optimisation intervention (n = 10 local authorities) 50.0 17.1      
  1. aCalculation of outcomes used data provided for randomisation
  2. bCalculation of outcomes used data from the most recently delivered HENRY programme during follow-up at 18 months post-randomisation
  3. cVariables controlled for in the adjusted analyses were as follows: proportion of children’s centres recruiting at least 8 parents per programme at randomisation, proportion of children’s centres retaining at least 75% of parents for a minimum of 5/8 sessions per programme at randomisation, proportion of children’s centres running at least one HENRY programme in 2015, size of local authority and proportion of children’s centres in the least/most deprived quintile as ranked by the 2015 Index of Multiple Deprivation at the Lower Layer Super Output Area
  4. Abbreviations: RD risk difference, CI confidence interval, ICC intra-cluster correlation coefficient