title: Effect of a participant-driven health education programme in primary care for people with hyperglycaemia detected by screening: 3-year results from the Ready to Act randomized controlled trial (nested within the ADDITION-Denmark study).
abstract: OBJECTIVE
  To assess whether a 12-week participant-driven health education programme offered to individuals with screening-detected hyperglycaemia in Danish primary care would lead to improvements in cardiovascular risk factors, health behaviour and patient-reported outcomes after 3 years.
  
  
  METHODS
  We conducted a randomized controlled trial in 509 patients with screening-detected hyperglycaemia (impaired fasting glucose, impaired glucose tolerance or type 2 diabetes) from 33 general practices in Denmark. Individuals were pre-randomized to receive (i) routine care (n = 187), or (ii) an invitation to participate in the Ready to Act health education programme (n = 322). The programme was delivered over 12 weeks in primary care and focused on motivation, action experience, informed decision-making and social involvement to promote health behaviour change. The primary outcome was 10-year modelled cardiovascular risk.
  
  
  RESULTS
  Of 322 individuals, 123 (38%) received the intervention and 436/509 individuals (86%) returned for follow-up assessment. There was no difference between the trial groups in modelled cardiovascular risk at 3 years (relative difference: 1.01; 95% CI: 0.84 to 1.23). Total cholesterol was lower (-0.24mmol/l, 95% CI: -0.45 to -0.03, P = 0.027), and patient activation was higher in the intervention than in the control group (5.3, 95% CI: 0.97 to 9.7). No other between-group differences were observed for any cardiovascular risk factor, health behaviour or patient-reported outcome variables. Subgroup analyses suggested that the intervention was more beneficial in those with impaired fasting glucose/impaired glucose tolerance than in those with type 2 diabetes.
  
  
  CONCLUSIONS
  For patients with screening-detected hyperglycaemia, a participant-driven health education programme was not associated with improvements in most clinical, behavioural and patient-reported outcomes after 3 years of follow-up.
authors.affiliation: Health Promotion and Health Services Research, Department of Public Health, Aarhus University, Aarhus, Denmark.
authors.forename: H T
authors.initials: HT
authors.lastname: Maindal
authors.forename: A H
authors.initials: AH
authors.lastname: Carlsen
authors.forename: T
authors.initials: T
authors.lastname: Lauritzen
authors.forename: A
authors.initials: A
authors.lastname: Sandbaek
authors.forename: R K
authors.initials: RK
authors.lastname: Simmons
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications / Q000209:etiology / Q000517:prevention & control*; D003131:Combined Modality Therapy; D003718:Denmark / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000150:complications / Q000517:prevention & control; D058065:Diabetic Cardiomyopathies / Q000150:complications / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D018149:Glucose Intolerance / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D015438:Health Behavior; D006801:Humans; D006937:Hypercholesterolemia / Q000150:complications / Q000209:etiology / Q000517:prevention & control; D008019:Life Style; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D057285:Precision Medicine; D011236:Prediabetic State / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011320:Primary Health Care; D012307:Risk Factors