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

Imai 2008.

Study characteristics
Methods Intervention with delivery of diabetic meals improves glycemic control in patients with type 2 diabetes mellitus
RCT (NA clusters and NA providers), conducted in 1) Participants were recruited from outpatients attending the Kajiyama Clinic between 2004 and 2005, in Kyoto, Japan. 2) The intervention involved diabetic meals delivered at home, individual diet counselling with dietitians or conventional dietary education by either a doctor or nurse. In Japan.
3 arms: 1. Control (conventional dietary education) (control arm) and 2. Intervention 1 (individual diet counselling) (intervention arm), 3. Intervention 2 (meal delivery and sessions with dietitians) (other arm)
Participants Control arm N: 30
Intervention arm N: 30, 30, NA
Diabetes type: 2
Mean age: 63.62 ± 14.03
% Male: 45.45
Longest follow‐up: 12 months
Interventions Control arm: (conventional dietary education)
1) Patient education
Intervention arm: (individual diet counselling)
1) Case management
2) Patient education
3) Promotion of self‐management
Intervention arm: (meal delivery and sessions with dietitians)
1) Case management
2) Patient education
Outcomes Glycated haemoglobin
Low‐density lipoprotein
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. A total of 77 adults with type 2 diabetes who attended the clinic were assigned into 3 dietary groups by the stratified randomisation method that considered age, gender, and duration of diabetes.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values above 0.05. There were no significant differences between the 3 groups with respect to age, sex, diabetes duration and glucose control methods.
Patient's baseline outcomes (selection bias) Low risk Table 1. All P values above 0.05. There were no significant differences between the three groups with respect to body mass index (BMI), FBG, HbA1c, T‐Ch, HDL‐Ch, LDLCh and TG.
Incomplete outcome data (attrition bias) High risk In this study, we first assigned 30 patients in each of the 3 groups. However, 12 patients in the group with meal delivery and sessions with dietitians (40% lost) were not able to complete the intervention. The main reasons were particular food preferences and the cost of the meal delivery. Problems with intervention feasibility. No patient was lost in the control group and 1 was lost in the diet counselling group (3.3%). Numbers unbalanced between groups.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective outcomes (HbA1c and LDL).
Selective reporting (reporting bias) Unclear risk No registered protocol. They report HbA1c at months 1, 2, 3, 6, 9 and 12 (Figure 1), but not for fasting blood glucose (just at baseline and endpoint, both primary outcomes). They only report blood pressure at baseline.
Risk of contamination (other bias) Unclear risk The conventional dietary education group (control) involved the patients receiving their usual outpatients management every month. The control group received higher level of attention compared to most studies included in this systematic review (control patients usually visit their caregivers every 3 to 4 months). Dieticians saw participants in both intervention groups.
Other bias Low risk No evidence of other bias.