Table 4

Analysis plan: objectives, outcome, hypothesis and methods of analysis

ObjectiveOutcomesMeasurementCriteria for successMethod of analysis
Primary clinicalGlycaemic response to the 75 g oral glucose tolerance testArea under the curve of glucoseMean statistically significant reduction of 15% in the intervention armLinear regression*
Secondary clinicalGestational diabetes diagnosed by 75 g oral glucose tolerance testFasting glucose>5.2 mmol/L, or 2 hours post 75 g load>7.2 mmol/LOR<0.9=signal of benefit
OR>1.1=signal of harm
Logistic regression*
AcceptabilityAcceptabilityAnswer to the question ‘Would you recommend this programme to a friend?’≥80% of participants reply ‘agree or strongly agree’Descriptive statistic (proportion)
  • *Mixed models will be considered to adjust for centre effects using random intercepts.