Analysis plan: objectives, outcome, hypothesis and methods of analysis
Objective | Outcomes | Measurement | Criteria for success | Method of analysis |
Primary clinical | Glycaemic response to the 75 g oral glucose tolerance test | Area under the curve of glucose | Mean statistically significant reduction of 15% in the intervention arm | Linear regression* |
Secondary clinical | Gestational diabetes diagnosed by 75 g oral glucose tolerance test | Fasting glucose>5.2 mmol/L, or 2 hours post 75 g load>7.2 mmol/L | OR<0.9=signal of benefit OR>1.1=signal of harm | Logistic regression* |
Acceptability | Acceptability | Answer 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.