Table 1.

Standard Protocol Items (SPIRIT): details on the scheduled activities related to patient enrollment, interventions, and study variables at different time points

	Study period
	Enrollment	Allocation	Post allocation					Closeout
Time point	−T1	T0	T1	T2	T3	T4	T5	T6
Enrollment
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions		X	X	X	X	X	X	X
Assessments
Major cardiovascular events			X	X	X	X	X	X
Health behaviors
Smoking status		X	X	X	X	X	X	X
Dietary intake		X	X	X	X	X	X	X
Physical activity		X	X	X	X	X	X	X
Medication adherence		X	X	X	X	X	X	X
Anthropometry parameters
Weight		X	X	X	X	X	X	X
Body mass index		X	X	X	X	X	X	X
Waist circumference		X	X	X	X	X	X	X
Biochemical parameters
Total cholesterol		X		X	X	X	X	X
Low-density lipoprotein cholesterol		X		X	X	X	X	X
High-density lipoprotein cholesterol		X		X	X	X	X	X
Fasting blood glucose		X		X	X	X	X	X
Hemoglobin A1c		X		X	X	X	X	X
Systolic blood pressure		X		X	X	X	X	X
Diastolic blood pressure		X		X	X	X	X	X
10-year Framingham risk scores of cardiovascular risks		X		X	X	X	X	X
All-cause mortality			X	X	X	X	X	X
All-cause readmission			X	X	X	X	X	X
Frequency of medical treatment due to CHD			X	X	X	X	X	X
Patients’ engagement in the intervention			X	X	X	X	X	X
Mediators and moderators of behavior changea
Risk perception		X			X	X	X	X
Outcome expectation		X			X	X	X	X
Action planning		X			X	X	X	X
Coping planning		X			X	X	X	X
Behavioral enjoyment		X			X	X	X	X
Social support		X			X	X	X	X
Self-efficacy		X			X	X	X	X
Effectiveness perception		X			X	X	X	X
Intention		X			X	X	X	X
Motivation		X			X	X	X	X
Volition		X			X	X	X	X
Stages of behavior changea		X			X	X	X	X
Knowledge of CHD		X			X	X	X	X
Perceived importance of health behaviors		X			X	X	X	X

CHD, coronary heart disease. −T1: Start point for patient recruitment; T0: Baseline; T₁: 1 month; T₂: 3 months; T₃: 6 months; T₄: 12 months; T₅: 24 months; T₆: 36 months

^aThe stages of behavior change, mediators and moderators of behavior change will be assessed dynamically