Measure or Instrument name | INTERVAL | INFORM baseline | INFORM follow-up | Mode of assessment | Note | |
---|---|---|---|---|---|---|
Primary outcome | Physical Activity Level* | ✓ | ✓ | ✓ | accelerometers | using the Axivity AX3 – 3Axis logging Accelerometer® |
Secondary outcomes | Traditional risk factors | |||||
 Fruit and vegetables intake | ✓ | ✓ | carotenoids | |||
 Weight | ✓ | ✓ | self-report | |||
 Cholesterol Panel (total, HDL and LDL cholesterol, triglycerides) | ✓ | ✓ | blood serum | |||
 Fructosamine | ✓ | ✓ | blood serum | |||
 Nutrition Behaviour (fruit, vegetables, whole grains, fish, red and processed meat) | ✓ | ✓ | self-report | one-item questions that reflect the present prevention guidelines on CVD [16, 10] | ||
 Physical Activity Level | ✓ | ✓ | self-report | EPIC-Norfolk Physical Activity Questionnaire [60] | ||
 Smoking Status | ✓ | ✓ | self-report | |||
 Alcohol Consumption | ✓ | ✓ | self-report | |||
 Current Medication and Healthcare Usage | ✓ | ✓ | self-report | adapted version of the Health Services Research Unit Aberdeen questionnaire [61] | ||
Perceived risk | ||||||
 Comparative and Absolute Cardiovascular Risk | ✓ | ✓ | self-report | adapted according to Diefenbach et al. [62] and used in other risk communication studies [48, 56] | ||
Cognitive evaluation of provision of coronary heart disease risk scores | ||||||
 Understanding of Risk Scores | ✓ | self-report | as used in another trial of risk communication [56] | |||
 Perceived Accuracy of Risk Scores | ✓ | self-report | ||||
 Acceptability of the Intervention | ✓ | self-report | in line with the Heart to Health study [50] | |||
Psychological outcomes | ||||||
 Stress | ✓ | ✓ | self-report | as used in the Randomized Trial of Personal Genomics for preventive cardiology [48] | ||
 Mood | ✓ | ✓ | self-report | adapted from the Patient Health Questionnaire [63] | ||
 Coronary Heart Disease-related Worry | ✓ | ✓ | self-report | an adaptation of the Cancer Related Worry Scale [64] | ||
 Genetic Risk-related Worry/Anxiety | ✓ | self-report | as used by Knowles et al. [48] | |||
Moderators and mediators |  Sociodemographic characteristics | |||||
 Sex, Age, Ethnicity | ✓ | self-report | ||||
 Marital Status | ✓ | self-report | ||||
 Socioeconomic Status (level of education, level of income, living area) | ✓ | self-report | adapted from the European Health Interview Survey; deprivation level of the area based on the Index of Multiple Deprivation, Department for Communities and Local Government | |||
 Numeracy Skills | ✓ | self-report | 3-item Schwartz scale [65] | |||
 Family History of Coronary Heart Disease | ✓ | self-report | ||||
 History of Genetic Testing | ✓ | self-report | ||||
 History of Coronary Heart Disease Risk Assessment | ✓ | self-report | ||||
 Self-rated Health | ✓ | ✓ | self-report | Ware et al. [66] | ||
 Barriers to risk-reducing strategy | ✓ | self-report | in line with the Heart to Health study [50] | |||
 Cognitive and emotional theory-based antecedents to behaviour change | ||||||
 Intentions | ✓ | self-report | adapted according to Ajzen [67] and used in previous similar research [56] | |||
 Perception of Diet | ✓ | self-report | ||||
 Perception of Physical Activity | ✓ | self-report | ||||
 Coronary heart disease risk Representations | ✓ | self-report | the Brief Illness Perceptions Questionnaire [68] | |||
 Self-efficacy | ✓ | self-report | ||||
 Response Efficacy | ✓ | ✓ | self-report | |||
 Social Support | ✓ | self-report | the Multidimensional Scale of Perceived Social Support [70] | |||
 Time Orientation | ✓ | self-report | as used in a study by Peretti-Watel et al. [71] | |||
 Sense of Coherence | ✓ | self-report | 3-items scale, Lundberg et al. [72] | |||
 Comparative Optimism | ✓ | self-report | comparative perceived risk |