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

Perry 1997.

Study characteristics
Methods Lifestyle intervention in people with insulin‐dependent diabetes mellitus (IDDM)
Cross‐over RCT (NA clusters and NA providers), conducted in 1) Participants were recruited from the Dunedin Public Hospital Diabetes Clinic and from those responding to a request for volunteers in a radio interview, and in local newspaper advertisements. The study was conducted in the Department of Human Nutrition at the University of Otago in Dunedin, New Zealand. Physical fitness appraisal and training programmes were conducted by the School of Physical Education at the University of Otago. 2) Participants met with the research team at least monthly. No details on team members' expertise (from the department of nutrition, medicine and mathematics). In New Zealand.
2 arms: 1. Control (Group 2: standard care) (control arm) and 2. Intervention (Group 1: intensive lifestyle education) (intervention arm)
Participants Control arm N: 36
Intervention arm N: 34, NA, NA
Diabetes type: 1
Mean age: 42.14 ± 10.03
% Male: 57.38
Longest follow‐up: 6 months
Interventions Control arm: (standard care)
Intervention arm: (intensive lifestyle education)
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Funding source This study was supported by the Eli Lilly Research Grant (Eli Lilly and Company (New Zealand) Ltd), The Deans Research Grant (Otago Medical School, New Zealand) and The New Zealand Dietetic Association (Abbott Award)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. Participants were randomised after stratification for age and gender to either Group 1 or Group 2.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Unclear risk Table 1. No P values. Data only for those who completed the study. Looks like there are more males in group 2.
Patient's baseline outcomes (selection bias) Unclear risk Table 3. No P values. Data only for those who completed the study.
Incomplete outcome data (attrition bias) High risk They lost a total of 9 out of 70 patients randomised (12.9%), 3 out of 34 in Group 1 (8.8%) and 6 out of 36 in Group 2 (16.7%). Numbers unbalanced. 61 participants completed the study (31 in Group 1 and 30 in Group 2). 9 participants (3 from Group 1 and 6 from Group 2) did not complete the study.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Our outcomes of interest were objectively measured (HbA1c, SBP, DBP and LDL).
Selective reporting (reporting bias) Unclear risk No registered protocol. No data on BMI.
Risk of contamination (other bias) Low risk Intervention delivered by research team, unlikely that control group would receive intervention.
Other bias Low risk No evidence of other bias.