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Table 2 Data collection components and timepoint of collection

From: Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: ‘OPTIMISE your health’ trial protocol

Data collection component

Timepoint

0 M

3 M

6 M

12 M*

15 M*

18 M*

Clinical assessment (in person)

Fasting venous blood draw a

 

OGTT b

 

Anthropometric b

 

DXA b

 

Blood Pressure b

 

FMD b

 

Cognitive Testing b

 

 

Device-based monitoring

activPAL

GT3X+

 

Activity Monitor Diary

Surveys (administered during clinic visit)

Health History Survey

     

Medication Log a

 

Allied Health Log a c

 

OPTIMISE Survey a

Personal wearables questionnaire b c

 

‘Typical 24 h’ Survey d

    

Surveys (self-completion)

Dietary intake questionnaire

 

Quality of Life Survey

 

Menstrual Status Questionnaire c (women only)

 

 

Motivation for Physical Activity Survey c

 

Motivation to Break Up Sitting survey c

 

OPTIMISED Survey (delayed intervention) *

    

COVID-19 impact questionnaire e

 

Implementation / intervention fidelity data

REDCap Metadata: instrument status, dates & times

Fitbit usage

 

propelo™ message log: full record of all messages sent/received

  

 

Health coaching forms

 

   

Tailoring forms

  

   

Withdrawal and adverse events log f

  1. Abbreviations: OGTT oral glucose tolerance test, DXA dual energy x-ray absorptiometry; FMD flow-mediated dilation
  2. * Expanded protocol only
  3. a Replaced with COVID-safe alternative during restrictions (self-completion questionnaire; self-report; no clinical visit, pathology visit HbA1c test only)
  4. b Dropped during COVID restrictions
  5. c Added part way through study
  6. d Subsample only - recruited first 30 participants, completed before expanded protocol began
  7. e Not timed with the assessments but triggered by events: soon after the Australian government implemented restrictions March 2020 (COVID-19 pandemic restrictions) or upon reporting of a withdrawal or adverse event
  8. f When reported