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Table 1 Measures used at baseline and one year in the ADDITION-Plus trial (Cambridge, UK)

From: Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care

Measures

Baseline

One year

 

C

I

C

I

Objectively measured health behaviours

Physical activity (ActiHeart)[47]

  

X

X

Dietary intake (plasma vitamin C concentration)

X

X

X

X

Medication adherence (plasma drug concentrations)

  

X

X

Smoking status (plasma cotinine concentration)

  

X

X

Self-reported health behaviours

Physical activity: EPAQ-2 [52], IPAQ [53]

X

X

X

X

Dietary intake: EPIC food frequency questionnaire [54]

X

X

X

X

Medication adherence:

    

   All drugs during the last month [34]

X

X

X

X

   Hypoglycaemic drugs during the last month [34]

  

X

X

Smoking status and alcohol consumption (questionnaire)

X

X

X

X

CVD risk

    

Modelled ten-year CVD risk: UKPDS risk engine, v3 [33]

X

X

X

X

Self-reported history of angina, heart attack and stroke

X

X

X

X

Biochemical measures

HbA1c, total cholesterol, HDL and LDL cholesterol, triglyceride, urea and electrolytes, creatinine, albumin, bilirubin, alanine amino transferanse (ALT), alkaline phosphatase, aspartate aminotransference (AST), thyroid stimulating hormone (TSH), urine albumin/creatinine ratio

X

X

X

X

Clinical measures

Waist circumference, height, weight, blood pressure, pulse, body fat impedance and ECG

X

X

X

X

Cardiorespiratory fitness measured using a sub-maximal VO2 test[47]

  

X

X

Rose angina questionnaire [55]

  

X

X

Neuropathy questionnaire (adapted from the Michigan screening instrument) 1

X

X

X

X

Health utility, functional status, quality of life, well-being, treatment satisfaction and anxiety

Diabetes well-being (WBQ-28) [57]

  

X

X

SF-36 [74]

  

X

X

Diabetes-related quality of life (ADDQOL) [57]

  

X

X

Diabetes Treatment satisfaction (DTS) [57]

  

X

X

EuroQol EQ-5D [59]

X

X

X

X

Consultation and relational empathy measure (CARE) [61]

  

X

X

Spielberger Short form State anxiety inventory [60]

X

X

X

X

Assessment of diabetes services

  

X

X

Frequency of and views about self-monitoring of blood glucose (DiGEM questionnaire [62])

  

X

X

Beliefs about behaviour change, illness perceptions and habit

Beliefs about behaviour change: intention, perceived behavioural control, behavioural beliefs (physical activity, eating a low-fat diet; taking medication and smoking cessation) [29]

X

X

X

X

Illness perceptions (consequences and treatment control sub-scales IPQ-R) [65]

X

X

X

X

Diabetes knowledge1

  

X

X

Habit [67]) in relation to physical activity and dietary change

  

X

X

Intervention evaluation

Facilitator assessment

   

X

Skills in last 12 months in relation to lifestyle change and medication taking1

   

X

Costs

Self-reported current medication/vitamins

X

X

X

X

Personal patient costs1

X

X

  

Health service and medication use in the previous three months (adapted from the Aberdeen Health Service Research Unit questionnaire) 1

  

X

X

  1. C = control group; I = intervention group; 1 Questionnaire developed for the study
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BMC Public Health

ISSN: 1471-2458

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