Murray 1986.
Methods |
Design: RCT Setting: Heart Health Centre in Mankato, Minnesota (a southern Minnesota community of 35,000) Dates: Intervention group recruited September to December 1982, control group recruited September to December 1983. Intervention group returned for follow‐up September to December 1983. Follow‐up: 1 year |
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Participants | N randomised: 2323 (Intervention n = 1156, Control n = 1167) addresses were randomised Of 2323 addresses, 4.0% were non‐residences and 3.6% could not be contacted Of 2146 addresses contacted, 12.6% had no age‐eligible residents Participation rates at initial screen equivalent for intervention and control groups (50.6%). No adults agreed to participate in 43.1% of households and 6.3% agreed to attend but did not keep appointment Final numbers included in analyses: Intervention n = 428 Control n = 478 Overall healthy population. From the addresses randomised, 1 resident was randomly selected from those aged 25 ‐ 74 years. Treatment group participants who moved out of town prior to follow‐up were excluded from analyses (32, 7%). 49/428 (11.4%) of treatment group were lost to follow‐up (data from baseline visit were substituted for follow‐up data where possible) Age (assume mean) years: Intervention 43.8, control 43.9 Men %: intervention 43.0, control 40.0 |
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Interventions |
Setting: Heart Health Centre Intervention: After giving informed consent, participants were tested for total serum cholesterol, height and weight, blood pressure, expired‐air carbon monoxide, and leisure‐time physical activity. Results of these tests were returned during the visit. Participants received a health education message on videotape, printed materials or both, focused on changing behaviour, on diet, physical activity, stopping smoking or helping smokers to stop, reading food labels. Color‐coded risk factor cards used to record each participant’s risk factor level and to provide a message tailored to the risk factor value. Each family spent 20 min with a health educator to review the test results. The average visit lasted 75 min. A second measurement was made if diastolic blood pressure was 90mmHg or higher or total cholesterol was 300 mg/dl or greater, if this remained the case a referral was made to a local physician. Control: received intervention one year later (no baseline assessment of risk factors which might motivate behaviour change). |
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Outcomes | BP, total cholesterol, attendance rates | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Heart Health Centre staff were not informed of the study until its conclusion. Participants were not informed of their treatment condition and were scheduled together during the 1983 follow‐up. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Cholesterol was analysed at a central laboratory (as well as at the Heart Health Centre) where staff were blinded to identity and prior Heart Health Centre cholesterol value |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to be similar between groups, in effect the last observation carried forward was used for losses to follow‐up from the intervention group. |
Selective reporting (reporting bias) | High risk | Limited data; no measures of variance reported |
Other bias | Unclear risk | Not reported |