| V0 |
Physical baseline assessments and initial registration |
Enrollment—≥7 days before the beginning of the intervention |
Collect consent Collect demographic information: date of birth, sex, smoking and drinking status, medical history, diet and exercise habit, household living condition, employment, use of smartphones, habit of step count measurement, and stage of behavior change according to the transtheoretical model of change regarding walking 10,000 steps a day Collect physical data: blood tests to measure HbA1ca, FBGb, LDLc cholesterol, HDLd cholesterol, TGe, and eGFRf; urinalysis; and height, body weight, and BPg measurements Collect medication and combination therapy status Assess health literacy Conduct surveys (Textbox 4) Distribute pedometer and placebo-equipped phone
|
| V1 |
Step count baseline |
From V0 to the day before V2 (at least 7 days) |
|
| V2 |
Registration, allocation, and beginning of the intervention |
Beginning of the intervention (end of week 0) |
Measure HbA1c level Finalize registration and allocation Distribute BP monitor and scale Activate all placebo and StepAdd features Collect medication and combination therapy status Check for adverse events
|
| M |
Ongoing measurement |
From V2 to V8 |
Daily measurements via app Intervention only: daily feedback, weekly feedback, and weekly personalized goal setting via app Check for defects
|
| V3 |
Hospital visit 1 |
End of week 4 |
Check app use and equipment Check for adverse events Intervention: coach goals and coping strategies Collect medication and combination therapy status
|
| V4 |
Hospital visit 2 |
End of week 8 |
Check app use and equipment Check for adverse events Intervention: coach goals and coping strategies Collect medication and combination therapy status
|
| V5 |
Interim hospital visit |
End of week 12 |
Collect physical data: blood tests to measure HbA1c, FBG, LDL cholesterol, HDL cholesterol, TG, and eGFR; urinalysis; and body weight and BP measurements Check app use and equipment Check for adverse events Intervention: coach goals and coping strategies Collect medication and combination therapy status Conduct surveys (Textbox 4)
|
| V6 |
Hospital visit 4 |
End of week 16 |
Check app use and equipment Check for adverse events Intervention: coach goals and coping strategies Collect medication and combination therapy status
|
| V7 |
Hospital visit 5 |
End of week 20 |
Check app use and equipment Check for adverse events Intervention: coach goals and coping strategies Collect medication and combination therapy status
|
| V8 |
End of the intervention |
End of week 24 |
Collect physical data: blood tests to measure HbA1c, FBG, LDL cholesterol, HDL cholesterol, TG, and eGFR; urinalysis; and body weight and BP measurements Collect medication and combination therapy status Check for adverse events Conduct surveys (Textbox 4) Assess usefulness and usability
|
| V9 |
End of follow-up |
End of week 36 |
Collect physical data: blood tests to measure HbA1c, FBG, LDL cholesterol, HDL cholesterol, TG, and eGFR; urinalysis; and body weight and BP measurements Collect medication and combination therapy status Check for adverse events Conduct surveys (Textbox 4)
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