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Table 2 INFORM measures at each stage of the study

From: Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour

  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 as used in Godino et al. [56] and Knowles et al. [48]
   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 as used in other risk communication studies [48, 56]
   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 as used in previous behavioural research [56, 68]
   Response Efficacy   self-report as used in previous behavioural research [52, 69]
   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
  1. *participants who did not take part in physical activity monitoring during the INTERVAL Study will be required to undertake baseline activity monitoring over 7 days