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. 2021 Nov 6;2021(11):CD001800. doi: 10.1002/14651858.CD001800.pub4

Heller 1993.

Study characteristics
Methods Study design: cluster‐randomised multicentre RCT
Country: Australia
Dates participants recruited: 18 September 1990 to 5 December 1991
Maximum follow‐up: 6 months
Participants Inclusion criteria: < 70 years with a suspected heart attack registered by the Newcastle collaborating centre of the WHO MONICA Project and discharged alive from hospital
Exclusion criteria: renal failure or other special dietary requirements and those considered by their physicians to have 'endstage' heart disease
N randomised: total: 450; intervention: 213; comparator: 237
Diagnosis (% of participants): MI: 100%
Age (mean ± SD): intervention: 59 ± 8; comparator: 58 ± 8
Percentage male: 71%
Ethnicity: NR
Interventions Intervention: a mail‐out programme designed to help participants reduce dietary fat, obtain regular exercise by walking and to quit smoking.
  • 1st package: Step 1 "Facts on fat" kit, together with walking programme information, encouragement to walk in the form of a magnetic reminder sticker, and "Quit for Life" programme for smokers.

  • 2nd package: Steps 2‐3 "Facts on fat" kit; exercise log.

  • 3rd package: Steps 4‐5 "Facts on fat" kit, together with information regarding local "Walking for Pleasure" groups.


Components: exercise plus education
Setting: home
Exercise programme modality: walking
Length of session: NR
Frequency: NR
Intensity: NR
Resistance training included? NR
Total duration: 6 months.
Co‐interventions: supplementary telephone contact was also used and a letter was sent to the family doctor regarding the benefit of aspirin and β blockers for secondary prevention.
Comparator: usual care
Co‐interventions: none described
Outcomes Total mortality, HRQL
Study outcomes assessed at 6 months
Source of funding National Health and Medical Research Council of Australia
Conflicts of interest NR
Notes Low use of preventative services (dietary, anti smoking) by both groups
10% of participants received CR ‐ mostly having had CABG
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Cluster‐randomisation by GP. "All general practices were randomly allocated to intervention or usual care within those strata." Method of randomisation not described.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding not described
Incomplete outcome data (attrition bias)
All outcomes High risk 17% lost to follow‐up; no description of withdrawals or dropouts
Selective reporting (reporting bias) Low risk All outcomes reported at all time points.