Table 3.

Secondary outcomes investigated in the study—22 areas spanning health outcomes, exercise outcomes, other behavior changes, and app assessments.

Categories and item numbers		Outcomes
Health outcomes
	1	HbA1ca level (%) Change in HbA1c levelb Proportion of patients with HbA1c level <7%c
	2d	FBGe (mg/dL) >5 hours after a meal
	3d	eGFRf (L/min/1.73m2)
	4d	BMI (kg/m2)
	5g	Body weight measured at home (kg)
	6	Systolic and diastolic BPh (mm Hg) BP measured at hospitald BP measured at homeg
	7d	HDLi (mg/dL), LDLj (mg/dL), and TGk (mg/dL)
	8l	Concomitant medication intake (type of medication and daily dosage or weekly dosage for weekly formulation) Change in type 2 diabetes medication intake (either increased, unchanged, or reduced) Introduction of new medications to treat type 2 diabetes, hypertension, or dyslipidemia
	9d	Type 2 diabetes–related emotional distress (assessed using Problem Areas in Diabetes) [45]
	10d	Type 2 diabetes–dependent quality of life (assessed using Audit of Diabetes-Dependent Quality of Life) [53]
Exercise outcomes
	11g	Daily step count
	12d	Walking duration
Other behavior changes
	13d	Locomotive syndrome (assessed using Locomo 25) [46]
	14d	Type 2 diabetes self-care, assessed using the Japanese version of the Summary of Diabetes Self-Care Activities Measure [51]
	15d	Self-management behaviors related to physical activity, assessed using Evaluation Scale for Self-Management Behavior Related to Physical Activity of Type 2 Diabetic Patients [47]
	16d	Self-regulation of physical activity, assessed using the Japanese version of Physical Activity Self-Regulation Scale–12 [50]
	17d	Changes in walking self-efficacy: Self-efficacy for achieving the targeted daily steps [48] Self-efficacy for dealing with barriers to achieving the targeted daily steps (assessed using Self-Efficacy Scale of Walking Behavior) [49]
	18d	Changes in self-efficacy in health-promoting behavior, assessed using Positive Coping Behavior Towards Illness subscale within Self-Efficacy Scale for Health Promoting Behaviors [52]
	19m	Health literacy, assessed using Health Literacy Scale 14 [56]
App assessments
	20n	App use is assessed through the following: Recording rate of body weight, step count, and BP and its changeo Goal achievement ratep Goal increment rateq Goal reduction rater Average number of coping planning strategies implemented per days Number of barrier identificationst
	21u	System feasibility and usability (only for the intervention group)
	22v	Number of emails, SMSs, and calls to encourage registration

^aHbA_1c: hemoglobin A_1c.

^bIncludes both differences between week 0 (registration at V2) and week 12 (V5; or point of discontinuation, if earlier) and between week 0 (registration at V2) and week 36 (V9; or point of discontinuation, if earlier), which are compared within group and between groups, and includes the difference between week 0 (registration at V2) and week 24 (V8; or point of discontinuation, if earlier), which are compared within group.

^cIncludes all 3 proportions that are compared between groups: latest HbA_1c level up to week 12 (V5; or point of discontinuation, if earlier) <7%, latest HbA_1c level up to week 24 (V8; or point of discontinuation, if earlier) <7%, and latest HbA_1c level up to week 36 (V9; or point of discontinuation, if earlier) <7%.

^dIncludes all 3 differences: between provisional registration (V0) and week 24 (V8; or point of discontinuation, if earlier), between provisional registration (V0) and week 12 (V5; or point of discontinuation, if earlier), and between provisional registration (V0) and week 36 (V9; or point of discontinuation, if earlier), which are compared between groups.

^eFBG: fasting blood glucose.

^feGFR: estimated glomerular filtration rate.

^gIncludes differences between the beginning of the intervention (V2; or from baseline period [V1] for steps) and week 4 (V3) and differences between each visit and each subsequent visit, which are compared between groups. In addition, they include measurements at each period (between visits), which are to be compared between groups. Item 11 also includes difference between baseline (V1) and 2 weeks before week 12 (V5; or point of discontinuation, if earlier) and week 24 (V8; or point of discontinuation, if earlier), which are compared within group and between groups.

^hBP: blood pressure.

ⁱHDL: high-density lipoprotein.

^jLDL: low-density lipoprotein.

^kTG: triglyceride.

^lIncludes assessment at week 12 (V5), week 24 (V8), and week 36 (V9; or point of discontinuation, if earlier), respectively, and it will be compared between groups.

^mWill be assessed at provisional registration (V0).

ⁿIncludes comparisons of the differences over the first period of the intervention (from week 0 [V2] to week 4 [V3]) and differences over each subsequent period (between subsequent visits), which are compared between groups (only the recording rate of body weight, step count, and BP and its change) and within group (all assessments).

^oFormula: (number of days in which measurements for BW, step count, and BP are recorded/total number of days) × 100.

^pFormula: (number of days in which step goal was achieved/total number of days) × 100; examined only for the intervention group.

^qFormula: (number of days in which step goal was increased/total number of reset times) × 100; examined only for the intervention group.

^rFormula: (number of days in which step goal was reduced/total number of reset times) × 100; examined only for the intervention group.

^sFormula: total number of coping strategies implemented over the period/total number of days; examined only for the intervention group.

^tNumber of barriers identified every 4 weeks; examined only for the intervention group.

^uWill be assessed for the intervention group only, at week 24 (V8; or point of discontinuation, if earlier).

^vWill be assessed at week 24 (V8; or point of discontinuation, if earlier).