Table 1 Standard Protocol Items (SPIRIT): details on the scheduled activities related to patient enrollment, interventions, and study variables at different time points

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 change^a

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 change^a

X

X

X

X

X

Knowledge of CHD

X

X

X

X

X

Perceived importance of health behaviors

X

X

X

X

X