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Table 7 Schematic diagram schedule of registration, screening assessments, interventions, and time point assessments for Project 2, 4 and 6a for intervention and control groups

From: Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose

 

Screening

Randomisation

Post-randomisation

Exit

 

1st

2nd

   

Timepoint [months]

   

4

6

12

24

36

40

46

 Registration

x

         

 Eligibility screen

x

x

x

       

 Informed consent

x

 

x

       

 Fasting plasma glucose

x

x

  

x

x

x

x

x

x

 HbA1c

x

x

  

x

x

x

x

x

x

 Fasting lipid profile

 

x

  

x

x

x

x

x

x

 Fasting plasma insulin

 

x

  

x

x

x

x

x

x

 HOMA IR

 

x

  

x

x

x

x

x

x

 Blood pressure

 

x

  

x

x

x

x

x

x

 Height

x

         

 Weight

x

 

x

x

x

x

x

x

x

x

 BMI

x

 

x

x

x

x

x

x

x

x

 Waist circumference

x

 

x

x

x

x

x

x

x

x

 Body fat mass

x

 

x

x

x

x

x

x

x

x

 Body fat %

x

 

x

x

x

x

x

x

x

x

 Accelerometerb

  

x

x

x

x

x

x

x

x

  1. aParticipants consented to Project 6 do not receive lipid and insulin analysis at baseline or at time points. These participants receive HbA1c and fasting plasma analysis at the 6, 12, 24 and 40 time points only
  2. bActigraph, LLC 17N, Tarragona Street, Pensacola, FL 32502, USA