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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Kirk 2009.

Study characteristics
Methods A randomized trial investigating the 12‐month changes in physical activity and health outcomes following a physical activity consultation delivered by a person or in written form in Type 2 diabetes: Time2Act
RCT (NA clusters and NA providers), conducted in 1) Study took place at the University of Dundee in Scotland sports centre, United Kingdom. 2) Intervention delivered by trained researcher. In United Kingdom.
3 arms: 1. Control (standard care) (control arm) and 2. Intervention 1 (written physical activity consultation, PAC) (intervention arm), 3. Intervention 2 (one‐to‐one physical activity consultation) (other arm)
Participants Control arm N: 35
Intervention arm N: 52, 47, NA
Diabetes type: 2
Mean age: 61.35 ± 9.2
% Male: 48.51
Longest follow‐up: 12 months
Interventions Control arm: (standard care)
1) Patient education
Intervention arm: (written physical activity consultation)
1) Case management
2) Patient education
3) Promotion of self‐management
Intervention arm: (one‐to‐one physical activity consultation)
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Funding source Thank you to Diabetes UK for funding this research (BDA:RD04/0003033)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. Participants were randomly assigned on an individual basis using consecutively numbered, sealed envelopes.
Allocation concealment (selection bias) Unclear risk Participants were randomly assigned on an individual basis using consecutively numbered sealed envelope (opaque?).
Patient's baseline characteristics (selection bias) Low risk Table 1. No significant between‐group differences were found at baseline on any measured outcome variable.
Patient's baseline outcomes (selection bias) Low risk Table 1. No significant between‐group differences were found at baseline on any measured outcome variable.
Incomplete outcome data (attrition bias) High risk Figure 1. A total of 18 patients were lost at 12 months out of the 134 randomised (13.4%). 4 were lost in the standard arm (11.4%), 9 in the written PAC (17.3%) and 5 in the person PAC (10.6%). Dropout from the study was around 10% (in‐person delivered and standard care) with slightly higher rates (17%) recorded in the written delivered group. At baseline, those who dropped out (n = 18) were similar in age, employment status and levels of physical activity, but had significantly higher BMI, HbA1c and socio‐economic deprivation (P < 0.05).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk All our outcomes of interest were objectively measured (HbA1c, SBP and DBP). Researchers conducting outcome measures were blind to group allocation at baseline and in most cases at 6 and 12 months.
Selective reporting (reporting bias) Unclear risk No registered protocol. Results match methods.
Risk of contamination (other bias) Unclear risk All patients received follow‐up phone calls and education. Control participants did not have physical education discussed during follow‐up call. Unclear who did the calling.
Other bias Low risk None.