Gamiochipi 2016.

Study characteristics
Methods	Effect of an intensive metabolic control lifestyle intervention in type‐2 diabetes patients RCT (NA clusters and NA providers), conducted in 1) The trial was carried out in eight Family Medicine Units (UMF) in Mexico City. 2) The IIEV (intervention) curriculum was applied by certified nutritionists. The COED (control) curriculum was applied by diabetes educators in Mexico. 2 arms: 1. Control (collaborative education model‐COED) (control arm) and 2. Intervention (intensive lifestyle intervention‐IIEV) (intervention arm)
Participants	Control arm N: 104 Intervention arm N: 95, NA, NA Diabetes type: 2 Mean age: 49.48 ± 9.33 % Male: 22.11 Longest follow‐up: 6 months
Interventions	Control arm: (collaborative education model‐COED) 1) Patient education 2) Promotion of self‐management Intervention arm: (intensive lifestyle intervention‐IIEV) 1) Case management 2) Patient education 3) Promotion of self‐management 4) Continuous quality improvement 5) Financial incentives
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein
Funding source	This work was funded by Research Grant 2004/497 from Fondo de Fomento a la Investigación (FOFOI)/IMSS.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A total of 199 patients accepted to participate in the trial (99% response rate), with 95 being assigned to the control group and 104 to the intervention group using the Epistat package (Epistat Services, Richardson, TX, USA). Epistat's 25 programs perform over 40 common statistical tests or functions and provide utilities for data entry, editing, printing, graphing, sorting, selecting, transforming and cross tabs.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. All P values above 0.05. Table 1 indicates the baseline characteristics for the 2 groups, and shows no significant differences.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All P values above 0.05. Table 1 indicates the baseline characteristics for the 2 groups, and shows no significant differences.
Incomplete outcome data (attrition bias)	Low risk	A total of 199 patients were recruited for the trial in 8 independent sites (Family Medicine Clinics). Of these, 17 did not finish the trial (8.5%); 7 had been assigned to the IIEV group, and 10 to the COED group (P > 0.05). Reasons not reported but small numbers and balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	All objective outcomes (HbA1c, SBP, DBP and LDL). Double‐blind evaluation of results.
Selective reporting (reporting bias)	Unclear risk	No registered protocol or previously published protocol. Method: measurements were taken at baseline, 3 and 6 months. The authors only report 6‐month results.
Risk of contamination (other bias)	Low risk	Each study arm was followed by different case managers. The IIEV (intervention) curriculum was applied by certified nutritionists while the COED (control) curriculum was applied by diabetes educators. Only the intervention arm received prizes, awards, calls and psychologist consultations. The 2 groups were summoned to the UMF on distinct non overlapping dates, and all patients were informed that recommendations would be individual.
Other bias	Low risk	None reported.