Background
Objectives
Primary objective
Secondary objectives
Objectives of the qualitative study
Methods/Design
Study design
Population
Setting
Recruitment
Consent
Baseline assessment
Randomisation, allocation concealment and blinding
Interventions
Group | Type | Lifestyle advice | Phenotypic risk score | Genetic risk score |
---|---|---|---|---|
1 | Control | No | No | No |
2 | Intervention | Yes | No | No |
3 | Intervention | Yes | Yes | No |
4 | Intervention | Yes | Yes | Yes |
Phenotypic CHD risk score
Genetic CHD risk score
Format of phenotypic and genetic risk
Lifestyle advice
Follow-up assessment
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 | |||
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 | |||
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 | ||||
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 |