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Table 2 Study schedule

From: The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle

 

Study period

Recruitment and allocation

Follow-up

Recruitment

Allocation

Post-allocation

Close-out

Visit

R1

R2

R3

R4

yr 1

F1

F2

F3

yr 2

F4

F5

F6

yr 3

F7

F8

F9

Time

−4 wks

−3 wks

−2 wks

−1 wk

mo 1

mo 4

mo 8

mo 12

mo 13

mo 16

mo 20

mo 24

mo 25

mo 28

mo 32

mo 36

Enrollment

                

 Eligibility screen

                

 Medical history

X

               

 Clinical examination

X

               

 LTPA questionnaire

X

               

 Confirmation of sedentary habits/ physical inactivity

  

X

             

 informed consent

X

               

 Demographics

X

               

 Cardiologic evaluation

X

               

 Allocation

   

X

            

Interventions

                

 CON group

                

 Physician recommends increasing daily PA

   

X

    

X

   

X

   

 INT group

                

 Theoretical session

   

X

    

X

   

X

   

 Theoretical and practical sessions

    

X

   

X

   

X

   

 Both: Standard care

                

Prescription

  

X

             

 Adjustment

     

Xa

Xa

Xa

 

Xa

Xa

Xa

 

Xa

Xa

Xa

Assessments

                

 Physical fitness

                

 Run-in familiarization session

 

X

X

             

 Assessment

   

X

   

X

   

X

   

X

 Accelerometer (key)

                

 Delivery of the key (and daily diary)

 

X

 

X

  

X

X

 

X

X

X

 

X

X

X

 Return of the key (and daily diary)

  

X

  

X

Xa

Xa

 

Xa

Xa

Xa

 

Xa

Xa

Xa

 CV risk factors

                

 Anthropometric data

  

X

  

X

X

X

 

X

X

X

 

X

X

X

 Bioimpedence

  

X

  

X

X

X

 

X

X

X

 

X

X

X

 Blood pressure

  

X

  

X

X

X

 

X

X

X

 

X

X

X

 Blood and urine testing

  

X

  

X

X

X

 

X

X

X

 

X

X

X

 Questionnaires

                

 MS

  

X

  

X

 

X

 

X

 

X

 

X

 

X

 WHO-5

  

X

  

X

 

X

 

X

 

X

 

X

 

X

 SF-36

  

X

  

X

 

X

 

X

 

X

 

X

 

X

  1. Overview of the study visits and assessments in the IDES_2
  2. aThree to 10 days after the visit
  3. IDES Italian Diabetes and Exercise Study, LTPA leisure time physical activity, CV cardiovascular, MS musculoskeletal, WHO World Health Organization, SF Short Form, CON control, INT intervention